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FDA Recalls

July 2009 - December 2009

Recalls as of December 30, 2009
Recalls as of December 23, 2009
Recalls as of December 16, 2009
Recalls as of December 9, 2009
Recalls as of December 2, 2009
Recalls as of November 25, 2009
Recalls as of November 18, 2009
Recalls as of November 11, 2009
Recalls as of November 4, 2009
Recalls as of October 28, 2009:
Recalls as of October 21, 2009:
Recalls as of October 14, 2009:
Recalls as of October 7, 2009:
Recalls as of September 30, 2009:
Recalls as of September 23, 2009:
Recalls as of September 16, 2009:
Recalls as of September 9, 2009:
Recalls as of September 2, 2009:
Recalls as of August 26, 2009
Recalls as of August 19, 2009
Recalls as of August 12, 2009
Recalls as of August 5, 2009
Recalls as of July 29, 2009
Recalls as of July 22, 2009
Recalls as of July 15, 2009
Recalls as of July 8, 2009
Recalls as of July 1, 2009

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 30, 2009:

CLASS II

PRODUCT: Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434. Recall # Z-0002-2009
MANUFACTURER: GE Medical Systems, LLC, Waukesha, WI, by letter dated March 7, 2008. Firm initiated recall is ongoing.
REASON: GE Healthcare has recently become aware of a potential risk of observing a blank image after exposure on Revolution XR/d systems equipped with HP 8200 PC user consoles that may impact patient safety. It was reported that images acquired with off-center collimation for extremities with the position selected as Digits to front or Digits to back are displayed as blank. Investigation into this issue revealed an error in the Revolution XR/d image processing software that controls rotation of collimator coordinates. This error causes the system to display a blank image when Digits to front or Digits to back are selected for off-center collimation exams.

PPRODUCT: MilCAM Recon III Model Family of IR Imagers that incorporate a Class I infrared laser for Laser Range Finding (LRF). Recall # Z-0937-2009
MANUFACTURER: Flir Systems, Inc., North Billerica, MA, by letter on March 28, 2009. Firm initiated recall is complete.
REASON: LRF models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations, Subchapter J, Parts 1000 - 1050 (21 CFR 1000 - 1050). A filter defect allows transmission of laser energy such that the affected LRF would be Class 3B laser product, however the product is reported to CDRH as a Class I product.

PPRODUCT: MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infrared laser pointer. Recall # Z-1223-2009
MANUFACTURER: Flir Systems, Inc., North Billerica, MA, by letter on April 17, 2009. Firm initiated recall is complete.
REASON: MilCAM Recon III models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations. Conditions of sale were not stated in variance approval letters issued for similar laser products.

PRODUCT:
1) GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems. Recall # Z-1257-2009;
2) GE Healthcare CT Systems Table Model Number 2271242 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems. Recall # Z-1258-2009;
3) GE Healthcare CT Systems Table Model Number 2269165 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems. Recall # Z-1259-2009
MANUFACTURER: GE Medical Systems, LLC, Waukesha, WI, by visit beginning April 27, 2009. Firm initiated recall is ongoing.r> REASON: Failure to provide the certification label required by 21 CFR 1010.2.

PRPRODUCT: Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies. Recall # Z-1658-2009
MANUFACTURER: NRT - Nordisk Rontgen Teknik A/S, Hasselager, Denmark, by letter dated May 1, 2009. Firm initiated recall is ongoing.
REASON: The GE Precision MPi is in violation with 21 CFR Part 1020.32 requiring a signal audible to the fluoroscopist to sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure.

PRODUCT:
1) GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-1687-2009;
2) Innova 3100, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-1688-2009;
3) GE Innova 3100-IQ, Cardiovascular Imaging System, (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall Z-1689-2009;
4) GE Innova 4100, (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-1690-2009;
5) GE Innova 4100-IQ, (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-1691-2009
MANUFACTURER: GE Healthcare, Waukesha, WI, by letter dated November 3, 2008. Firm initiated recall is ongoing.
REASON: During a Maximum Air Kerma Rate (AKR) calibration procedure check, GE Healthcare found the AKR calibration procedure does not exactly reflect the worst-case clinical usage of the product. This may result, when using large Equivalent Patient Thickness and in some rare cases of system/set-up combinations, in a non-compliance with 21 CFR 1020.32. The non-compliance may exceed the regulatory standard limit of 88mGy/min (10 R/min) by 6% (90.6 4mGy/min or 10.63R/min). The system works properly until the point where the maximum Air Kerma Rate is reached (88mGy/min or 10R/min).

PRODUCT: Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for percutaneous endoscopic placement to provide internal nutrition to patients requiring nutritional support. Recall # Z-1910-2009
MANUFACTURER: Cook Endoscopy, Winston Salem, NC, by letter on July 24, 2009. Firm initiated recall is complete.r> REASON: The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.

PRODUCT: iPulse Circulatory Support System Catalog number: 0036-0010 The iPulse System Console is a multi-purpose mechanical circulatory support system used to support patients suffering from acute cardiovascular failure. The iPulse console can be used to drive exclusively one of two classes of therapeutic devices: either pneumatically actuated Ventricular Assist Devices (VADs) for total circulatory support, or (i.e., non-simultaneously) an intra-aortic balloon (IAB) catheter for counter-pulsation therapy. Recall # Z-1931-2009
MANUFACTURER: Abiomed, Inc., Danvers, MA, by letter on April 8, 2009. Firm initiated recall is complete.
REASON: iPulse Console SC1035 displayed a "Low Pressure / Low Flow" alarm and stopped pumping during patient transport in battery operation.

PRODUCT: ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L). Made in Switzerland. Twist drill for preparation of osteotomy during dental implant surgical drilling procedure. Recall # Z-1947-2009
MANUFACTURER: Recalling Firm: Biomet 3i, LLC, Palm Beach Gardens, FL, by letter dated June 30, 2009. Manufacturer: Dentsply Maillefer, Ballaigues, Switzerland. Firm initiated recall is ongoing.
REASON: Some of the packages of ACT3020, drills may actually contain an ACT3220 drill.

PRODUCT: BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application. Recall # Z-2223-2009
MANUFACTURER: BioTek Instruments, Inc., Winooski, VT, by letters dated March 13, 2009 and March 25, 2009. Firm initiated recall is complete.
REASON: Software design allowed false negatives to be read when wells are dark.

PRODUCT: Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile. Disposable single-use devices indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgeries. Endoscopic instruments for surgery. Recall # Z-2226-2009
MANUFACTURER: Applied Medical Resources Corp., Rancho Santa Margarita, CA, by letter dated June 9, 2009. Firm initiated recall is ongoing.
REASON: Applied Medical is conducting a coluntary recall of two lot numbers, 1084426 and 1085506, of the 15mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in tip breakage.

PRODUCT:
1) St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372 Max. Guidewire O.D. .038", 2010-01, Sterile EO. Used for the introduction of catheters into a vessel. Recall # Z-2228-200;
2) St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM. Guidewire O.D .038", 2010-01, Sterile EO. Used for the introduction of catheters into a vessel. Recall # Z-2229-2009
MANUFACTURER: St. Jude Medical, Minnetonka, MN, by letter beginning August 28, 2009. Firm initiated recall is ongoing.
REASON: St. Jude Medical has initiated a voluntary recall of two lots of Fast-Cath Hemostasis Introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. They discovered that the product lots could contain some items which have been mis-labeled with the incorrect French size. In one case, the pouch label does not correctly identify the content of the pouch. In another case, the carton label is incorrect. The pouch label indicated that the product was 4F catheter, but the contents of the pouch may be a 7F catheter. St. Jude Medical has not received any reports of injuries resulting from this mis-labeling.

PRODUCT: ZOLL R Series Defibrillator/Pacemaker/Monitor Used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. Recall # Z-2315-2009
MANUFACTURER: ZOLL Medical Corporation, World Wide Headquarters, Chelmsford, MA, by letter on August 31, 2009 and on September 1, 2009. Firm initiated recall is ongoing.
REASON: Failure of Device to display ECG could delay delive CLASS II

PRODUCT: MilCAM Recon III Model Family of IR Imagers that incorporate a Class I infrared laser for Laser Range Finding (LRF). Recall # Z-0937-2009
MANUFACTURER: Flir Systems, Inc., North Billerica, MA, by letter on March 28, 2009. Firm initiated recall is complete.
REASON: LRF models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations, Subchapter J, Parts 1000 - 1050 (21 CFR 1000 - 1050). A filter defect allows transmission of laser energy such that the affected LRF would be Class 3B laser product, however the product is reported to CDRH as a Class I product.

PRODUCT: MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infrared laser pointer. Recall # Z-1223-2009
MANUFACTURER: Flir Systems, Inc., North Billerica, MA, by letter on April 17, 2009. Firm initiated recall is complete.
REASON: MilCAM Recon III models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations. Conditions of sale were not stated in variance approval letters issued for similar laser products.

PRODUCT:
1) GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems. Recall # Z-1257-2009;
2) GE Healthcare CT Systems Table Model Number 2271242 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems. Recall # Z-1258-2009;
3) GE Healthcare CT Systems Table Model Number 2269165 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems. Recall # Z-1259-2009
MANUFACTURER: GE Medical Systems, LLC, Waukesha, WI, by visit beginning April 27, 2009. Firm initiated recall is ongoing.
REASON: Failure to provide the certification label required by 21 CFR 1010.2.

PRODUCT: Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies. Recall # Z-1658-2009
MANUFACTURER: NRT - Nordisk Rontgen Teknik A/S, Hasselager, Denmark, by letter dated May 1, 2009. Firm initiated recall is ongoing.
REASON: The GE Precision MPi is in violation with 21 CFR Part 1020.32 requiring a signal audible to the fluoroscopist to sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure.

PRODUCT: Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for percutaneous endoscopic placement to provide internal nutrition to patients requiring nutritional support. Recall # Z-1910-2009
MANUFACTURER: Cook Endoscopy, Winston Salem, NC, by letter on July 24, 2009. Firm initiated recall is complete.
REASON: The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.

CLASS III

PRODUCT:
1) TI Cann Partl Thd Recon Screw 6.00MM x 65MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406065. Recall # Z-2277-2009;
2) TI Cann Partl Thd Recon Screw 6.00MM x 70MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406070. Recall # Z-2278-2009;
3) TI Cann Partl Thd Recon Screw 6.00MM x 75MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406075. Recall # Z-2279-2009;
4) TI Cann Partl Thd Recon Screw 6.00MM x 80MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406080. Recall # Z-2280-2009;
5) TI Cann Partl Thd Recon Screw 6.00MM x 85MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item 14-406085. Recall # Z-2281-2009;
6) TI Cann Partl Thd Recon Screw 6.00MM x 90MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406090. Recall # Z-2282-2009;
7) TI Cann Partl Thd Recon Screw 6.00MM x 95MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406095. Recall # Z-2283-2009;
8) TI Cannulated Screw 20MM thrd 6.5MM (d) X 85MM (L); Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number: 245846. Recall # Z-2284-2009;
9) TI Cannulated Screw 32MM thrd 7.3MM (d) X 95MM (L); Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 245958. Recall # Z-2285-2009;
10) TI Cannulated Screw 32MM thrd 7.3MM (d) X 100MM (L); Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number: 245960. Recall # Z-2286-2009;
11) TI Cannulated Screw 32MM thrd 7.3MM (d) X 120MM (L); Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 245968. Recall # Z-2287-2009;
12) TI Screw Buttress Thread 5MM (D) x 35MM (L) Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 33-345424. Recall # Z-2288-2009;
13) TI Screw Buttress Thread 6MM (D) x 65MM (L) Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 33-345534. Recall # Z-2289-2009;
14) Bone Screw 5.5MM X 45MM Bone Screw Lck-Cann, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27445. Recall # Z-2290-2009;
15) Bone Screw 5.5MM X 55MM Bone Screw Lck-Cann, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27455. Recall # Z-2291-2009;
16) Bone Screw 5.5MM X 70MM Bone Screw Lck-Cann, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 274470. Recall # Z-2292-2009;
17) Bone Screw 4.5MM X 20MM Bone Screw Lock, Rx only. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27820. Recall # Z-2293-2009;
18) Bone Screw 4.5MM X 28MM Bone Screw Lock, Rx only. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27828. Recall # Z-2294-2009;
19) Bone Screw 4.5MM X 36MM Bone Screw Lock, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27836. Recall # Z-2295-2009;
20) Bone Screw 4.5MM X 52MM Bone Screw Lck-Cann, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27852. Recall # Z-2296-2009;
21) Bone Screw .5MM X 60MM Bone Screw Lock, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27860. Recall # Z-2297-2009;
22) Bone Screw 4.5MM X 70MM Bone Screw Lock, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27870. Recall # Z-2298-2009;
23) Bone Screw4.5MM X 95MM Bone Screw Lock, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27895. Recall # Z-2299-2009;
24) Cannulated Screw Ballista Percutaneous Pedicle Screw System. 6/5 x 45MM; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 2000-3445. Recall # Z-2300-2009;
25) C-Tek Maxan Anterior Cervical Plate System; 4.0MM X 20MM Fixed Screw'; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-521520. Recall # Z-2301-2009;
26) Pediatric Femoral Nail 5.5MM (d) x 28 CM (L) Rx only, Sterile; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 24128. Recall # Z-2302-2009;
27) Pediatric Femoral Nail 5.5MM (d) x 30 CM (L) Rx only, Sterile; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 24130. Recall # Z-2303-200;
28) Pediatric Femoral Nail 5.5MM (d) x 32 CM (L) Rx only, Sterile; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 24132. Recall # Z-2304-2009;
29) Pediatric Femoral Nail 5.5MM (d) x 36 CM (L) Rx only, Sterile; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 24136. Recall # Z-2305-2009;
30) Fixed Closed Screw, 6.5mm (D) x 40mm (L), Made in USA; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog number 6147. Recall # Z-2306-2009;
31) Fixed Open Screw (TI); 7.0MM (D) x 30MM (L); Made In USA. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number 7140. Recall # Z-2307-2009;
32) Fixed Closed Screw (Ti); 5.0MM (D) x 25MM (L); Made in USA. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number 7155. Z-2308-2009;
33) Fixed Closed Screw (Ti); 6.0MM (D) x 40 MM (L) Made In USA. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number 7162. Recall # Z-2309-2009;
34) Bone Screw 6MM (D) x 35MM (L) Telescopic Plate Spacer, Thoracolumbar Spinal System Made in USA. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number 1300-0635. Recall # Z-2310-2009;
35) Bone Screw 7MM (D) x 35 MM (L) Telescopic Plate Spacer Thoracolumbar Spinal System; Made in USA. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number: 1300-0735. Recall # Z-2311-200;
36) Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number 6588. Recall # Z-2312-2009
MANUFACTURER: EBI, L.P., Parsippany, NJ, by letters dated March 29, 2009, April 2, 2009 and April 16, 2009, e-mail on May 22, 2009, and June 19, 2009. Firm initiated recall is ongoing.
REASON: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.

CLASS III

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 23, 2009:

CLASS I

PRODUCT: Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels. Recall # Z-0120-2010
MANUFACTURER: Thomas Medical Products Inc., Malvern, PA, by letter dated October 22, 2009. Firm initiated recall is ongoing.
REASON: Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces.

CLASS II

PRODUCT:
1) Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, nonsterile; REF 00-2490-001-00. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0375-2010;
2) Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, tall, nonsterile; REF 00-2490-001-05. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0376-2010;
3) Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, 0.512" wide, nonsterile; REF 00-2490-001-10. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0377-2010;
4) Zimmer Natural Nail System, Tibial Targeting Guide Handle, small, nonsterile; REF 00-2490-005-00. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0378-2010;
5) Zimmer Natural Nail System, Tibial Targeting Guide Handle, tall, nonsterile; REF 00-2490-005-03. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0379-2010;
6) Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, small, nonsterile; REF 00-2490-008-00. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0380-2010;
7) Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, small, 0.512" wide, nonsterile; REF 00-2490-008-10. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0381-2010;
8) Zimmer Natural Nail System, Antegrade Femoral Interlock Module, standard, nonsterile; REF 00-2490-001-03. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0382-2010;
9) Zimmer Natural Nail System, Antegrade Femoral Recon Module, standard, nonsterile; REF 00-2490-001-08. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0383-2010;
10) Zimmer Natural Nail System, Antegrade Femoral interlock Module, tall, nonsterile; REF 00-2490-001-53. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0384-2010;
11) Zimmer Natural Nail System, Antegrade Femoral Interlock Module, small, nonsterile; REF 00-2490-008-03. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0385-2010;
12) Zimmer Natural Nail System, Antegrade Femoral Recon Module, small, nonsterile, REF 00-2490-008-08. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0386-2010;
13) Zimmer Natural Nail System, REF 00-2490-005-04. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0387-2010;
14) Zimmer Natural Nail System, REF 00-2490-000-11. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0388-2010
MANUFACTURER: Zimmer Inc., Warsaw, IN, by e-mail on July 1, 2009, August 5, 2009, August 6, 2009, and by letter dated September 14, 2009. Firm initiated recall is ongoing.
REASON: The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.

PRODUCT:
1) Scorpio CR Basic Femur with Posts. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 70-3007R. Recall # Z-0466-2010;
2) Scorpio CR Waffle Femur Lfit with posts. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 70-4107R. Recall # Z-0467-2010;
3) Scorpio PS Basic Femur. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 71-3003L, and Catalog number 71-3005R. Recall # Z-0468-2010;
4) Scorpio PS Femur Waffle Posts with LfIt. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 71-4505L, and Catalog number 71-4505R. Recall # Z-0469-2010;
5) Scorpio NRG Cruciate Retaining Femoral, Left/Right # 5. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 80-4405L, and Catalog number 80-4405R. Recall # Z-0470-2010;
6) Scorpio NRG Cruciate Retaining Femoral, Right # 7. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 80-4407R. Recall # Z-0471-2010;
7) Scorpio NRG Cruciate Retaining Femoral, Left # 8. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 80-4408L. Recall # Z-0472-2010;
8) Scorpio NRG Posterior Stabilized Femoral, #3 Left. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog Number 81-4403L. Recall # Z-0473-2010;
9) Scorpio NRG Posterior Stabilized Femoral. # 4 left/right. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 81-4404L, and Catalog number 81-4404R. Recall # Z-0474-2010;
10) Scorpio NRG Posterior Stabilized Femoral, # 5 Left. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 81-4405L. Recall # Z-0475-2010;
11) Scorpio NRG Posterior Stabilized Femoral, # 7 left/right. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 81-4407L and Catalog number 81-4407R. Recall # Z-0476-2010;
12) Scorpio NRG Posterior Stabilized Femoral, #9 left. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog Number 81-4409L, Recall # Z-0477-2010
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on October 2, 2009. Firm initiated recall is ongoing.
REASON: It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barrier system.

PRODUCT: Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, Rx only. Protg EverFlex" Self-Expanding Peripheral Stent System (for Outside United States distribution). 6 x 100mm, Model Number PRP35-06-100-080. Sterile EO, Rx only. In the United States, the stent is intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the United States, it is intended indicated for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, superficial femoral, proximal popliteal, or subclavian arteries. Recall # Z-0478-2010
MANUFACTURER: Ev3, Inc., Plymouth, MN, by letters on November 9, 2009. Firm initiated recall is ongoing.
REASON: ev3 has determined that a lot of 150mm Protg EverFlex Biliary Stent System contains a 100mm length Self-Expanding stent. The implantation of a stent 50mm shorter than expected may not cover the full length of the target lesion and may require subsequent intervention.

PRODUCT: Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C, right, for cemented use only; REF 00-5764-013-52. Recall # Z-0501-2010
MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letter dated November 12, 2009. Firm initiated recall is ongoing.
REASON: The inner package may interfere with the outer seal, resulting in lack of assurance of sterility.

PRODUCT: 1) Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12. Recall # Z-0502-2010; 2) Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14. Recall # Z-0503-2010
MANUFACTURER: Alphatec Spine, Inc., Carlsbad, CA, by telephone on August 5, 2009. Firm initiated recall is ongoing.
REASON: Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.

PRODUCT:
1) Merit Medical Systems, Inc. Connection Tube label reading in part: Connecting Tube 12" Sterile K10-04129, Catalog number K10-04129 Connection tubing can be used with any drainage catheter and drainage bag. Recall # Z-0510-2010;
2) Merit Medical Systems, Inc. Connection tubes label reading in part: Connecting Tube w/ Stopcock 12" Catalog number K10-04131 LOT F720653 Connection tubing can be used with any drainage catheter and drainage bag. Recall # Z-0511-2010;
3) Merit Medical Systems, Inc. Monarch Inflation Syringe label reading in part: Monarch Catalog number IN2130 for inflation and deflation of interventional devices. Recall # Z-0512-2010;
4) Merit Medical Systems, Inc. Monarch Inflation Syringe Catalog number IN2230 for inflation and deflation of interventional devices. Recall # Z-0513-2010;
5) Merit Advance Angiographic Needle label reading in part: Majestik Series Angiographic Needles 20 G Catalog number AN20T52C for the introduction of vascular access devices. Recall # Z-0514-2010;
6) Merit Medical CT Transfer Set, REF/CAT No: TS120 Catalog #TS120/A - Transfer Set with filtered Sosa spike. Used to transfer contrast or saline into a sterile injector syringe. Recall # Z-0515-2010;
7) Merit Medical Systems, Inc. CT Transfer Set REF/CAT NO.: TS220. Recall # Z-0516-2010;
8) Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER 21G 6F-SMT 4 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries. Recall # Z-0517-2010;
9) Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER 21G 6F-SMT 4 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries. Recall # Z-0518-2010;
10) Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No.: PRO-6F-11-035 Prelude PRO SHEATH INTRODUCER 6F 11 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries. Recall # Z-0519-2010;
11) Merit Medical Systems, Inc. Medallion Syringe REF/CAT No.: MSS111-LB Indicated for use in cardiology and radiology procedures. Recall # Z-0520-2010;
12) Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation Device for Percutaneous Catheters Used to secure catheters in place without the use of sutures, reducing the exposure of sharps and sharp-related accidents. Recall # Z-0521-2010;
13) Merit Medical Systems, Inc. Futura Safety Scalpels, Futura Safety Scalpel REF/CAT No SMS210 Used for cutting tissue in surgical and laboratory procedures. Recall # Z-0522-2010;
14) Merit Medical Systems, Inc. Pressure Infusor Bag MERITMEDICAL 500 ml Pressure Infusor Bag Catalog number PIB500 Used to apply pressure to a sealed bag of sterile fluid. Recall # Z-0523-2010;
15) Merit Medical systems, Inc, Convenience Kit REF/CAT #: K09-07692 Revision A, Custom Kit. Recall # Z-0524-2010
MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by telephone and letter on September 29, 2009. Firm initiated recall is ongoing.
REASON: Potential sterility breach caused by excessive shipment damage.

PRODUCT: Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle screw system. Recall # Z-0554-2010
MANUFACTURER: Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter dated August 17, 2009. Manufacturer: Zimmer Spine Austin, Inc., Austin, TX. Firm initiated recall is ongoing.
REASON: The tip of the instrument may fracture during use.

PRODUCT: Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01. Recall # Z-0555-2010
MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letter dated February 25, 2009 and by e-mail on February 26, 2009.
REASON: Smaller diameter screws than required were included in the package.

PPRODUCT: 1) Stryker Howmedica Osteonics, Super SecurFit HA Hip Stem; Sterile Arc Deposited, V40 taper Not for use with 16mm heads. Catalog numbers: J6051-0425, J0651-0525, J6051-0625. Recall # Z-0556-2010; 2) Stryker Howmedica Osteonics, Primary Super SecurFit Stems, Sterile; Arc Deposited, V40 taper Not for use with 16mm heads. Catalog Number: J6054-XXXX. Recall # Z-0557-2010
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on January 14, 2009. Manufacturer: Stryker Ireland, Ltd., Orthopedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.
REASON: Stryker Orthopedics became aware that there may be difficulty in mating stem to implantation/extraction instrument./p>

PPRODUCT: Zimmer/CAS Power Cord, Sesamoid Plasty, NA; REF 20-8000-070-12. The device is the power cord component for the Sesamoid Plasty CAS workstation which connects the workstation to the power mains. Recall # Z-0558-2010
MANUFACTURER: Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter dated November 2, 2009. Manufacturer: Zimmer CAS, Montreal, Canada. Firm initiated recall is ongoing.
REASON: The power cord female receptacle is not recessed sufficiently and may present a shock hazard.

CLASS III

PRODUCT: E-Z CLEAN Non Stick Cautery Tip. Label reads in part: CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07***" The device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during general surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated. Recall # Z-0486-2010
MANUFACTURER: Megadyne Medical Products, Inc., Draper, UT, by letter dated October 13, 2009. Firm initiated recall is ongoing.
REASON: Product labels reference an incorrect expiration date. Expiration date referenced on labels is

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 16, 2009:

CLASS II

PRODUCT:
1) Heartstart FR2+ automated external defibrillator Models M3860A and M3840A are equipped with an ECG Module. M3860A is under the Philips label and M3840A is under the Laerdal label. 4 model (catalog) numbers are affected: M3860A, M3861A, M3840A, and M3841A. Specifics for each code: M3860A: Philips Heartstart FR2+ Defibrillator with ECG Module (various languages) M3861A: Philips Heartstart FR2+ Defibrillator Text Display, No ECG Module (various languages). M3840A: Laerdal Branded Heartstart FR2+ Defibrillator with ECG Module (various languages). M3841A: Laerdal Branded Heartstart FR2+ Defibrillator Text Display, No ECG Module (various languages). The following letter codes are used in conjunction with the catalog numbers to indicate language of Instructions for Use (IFU) and FR2+ voice prompts: ABA=U.S. English; ABU=U.K. English; ABD=German; ABE=Spanish; ABF=French; ABH=Dutch; ABI=Hong Kong; ABJ=Japanese; ABN=Norwegian; ABO=Taiwanese; ABS=Swedish; ABX=Finland; ABZ=Italian; AB2=China; and AC4=Portugal. Additional (non-language related) letter codes for product: A01=Product with TSO (Technical Standard Order) approved battery; and RF=Service Replacement. Recall # Z-0063-2010;
2) Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. Model M3861A is under the Philips label and M3841A is under the Laerdal label. Recall # Z-0062-2010
MANUFACTURER: Philips Medical Systems, Seattle, WA, by press release on September 28, 2009 and letters on October 1, 2009. Firm initiated recall is ongoing.
REASON: A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.

PRODUCT: Guider XF Softip Guide Catheter. The device is intended to facilitate placement of interventional devices into the neurovascular system. UPN/Model numbers: H965100420/10042, H965100430/10043, H965100440/10044, H965100460/10046, H965100470/10047, H965100480/10048, H965100500/10050, H965100510/10051, H965100520/10052, M003100620/10062, M003100630/10063, M003100640/10064, M003101420/10142, M003101430/10143, M003101440/10144, M003101460/10146, M003101470/10147, M003101480/10148, M003101500/10150, M003101510/10151, M003101520/10152, M003101620/10162, M003101630/10163 and M003101640/10164. Recall # Z-0107-2010
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Fremont, CA, by letter on October 6, 2009. Manufacturer: Boston Scientific Corp., Maple Grove, MN. Firm initiated recall is ongoing.
REASON: Product degradation-- a polymer portion of the distal section of the catheter may degrade prematurely, leading to potential systemic embolization of particulates with ischemic complications.

PRODUCT: Coloplast Titan OTR Inflatable Penile Prosthesis, 18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400. Sterile EO. Indicated for male patients suffering from erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis. Recall # Z-0171-2010br> MANUFACTURER: Coloplast Manufacturing, US, LLC, Minneapolis, MN, by letter dated October 2009. Firm initiated recall is ongoing.
REASON: Coloplast determined that a portion of Titan OTR pumps were manufactured using a process that where validation activities were not completed. The Titan OTR pumps were made to our standard product specifications and have passed all in-process testing to ensure mechanical reliability of these pumps. Coloplast is not recommending product explant because there are no identified risks since the product has been manufactured utilizing identical materials and processes compared to the existing Titan OTR pumps.

PRODUCT: Apligraf (draftskin) packaging. Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatment of full-thickness neuropathic diabetic foot ulcers. Recall # Z-0181-2010
MANUFACTURER: Organogenesis, Inc., Canton, MA, by letter dated September 28, 2009. Firm initiated recall is complete.
REASON: Unit contaminated with Staphylococcus epidermidis.

PRODUCT: Siregraph CF X-Ray System, Model Number: 4466033. Intended use: X-Ray, Fluoroscopic, Image-intensified. Recall # Z-0189-2010
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated September 11, 2009. Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany. Firm initiated recall is ongoing.
REASON: Possible injury to hand/fingers.

PRODUCT: NOVEL SPINAL SPACER SYSTEM, Part Number(s): a) 64817-010, b) 64817-012, c) 64817-013, d) 64817-014, e) 64817-107, f) 64113-012, g) 64113-010, h) 64765-109, i) 64733-124. Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology. Recall # Z-0190-2010
MANUFACTURER: Alphatec Spine, Inc., Carlsbad, CA, by telephone on May 13, 2009. Firm initiated recall is ongoing.
REASON: Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant.

PRODUCT:
1) Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Recall # Z-0194-2010;
2) Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080). EQL/27/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Recall # Z-0195-2010;
3) Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100). EQL/33/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Recall # Z-0196-2010;
4) Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120). EQL/40/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Recall # Z-0197-2010
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Maple Grove, MN, by letter dated September 29, 2009. Manufacturer: Boston Scientific Cork, Ltd, Cork, Ireland. Firm initiated recall is ongoing.
REASON: Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be breached. If a compromised seal is not detected and a sterility-compromised catheter is used clinically, there is a risk of adverse health consequences.

PRODUCT:
1)1) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 9 MM height, use with baseplate size 00 or 0, sterile; REF 00-5424-010-09 The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0199-2010;
2) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 11 MM height, use with baseplate size 00 or 0, sterile; REF 00-5424-010-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0200-2010;
3) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 13 MM height, use with baseplate size 00 or 0, sterile; REF 00-5424-010-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0201-2010;
4) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 16 MM height, use with baseplate size 00 or 0, sterile; REF 00-5424-010-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0202-2010;
5) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 19 MM height, use with baseplate size 00 or 0, sterile; REF 00-5424-010-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0203-2010;
6) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 9 MM height, use with baseplate size 1 or 2, sterile; REF 00-5424-011-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0204-2010;
7) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 11 MM height, use with baseplate size 1 or 2, sterile; REF 00-5424-011-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0205-2010;
8) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 13 MM height, for use with baseplate size 1 or 2 sterile; REF 00-5424-011-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0206-2010;
9) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 16 MM height, for use with baseplate size 1 or 2 sterile; REF 00-5424-011-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0207-2010;
10) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 19 MM height, for use with baseplate size 1 or 2 sterile; REF 00-5424-011-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0208-2010;
11) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 9 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5424-013-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0209-2010;
12) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 11 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5424-013-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0210-2010;
13) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 13 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5424-013-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0211-2010;
14) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 16 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5424-013-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0212-2010;
15) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left,19 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5424-013-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0213-2010;
16) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 9 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5424-020-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0214-2010;
17) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 11 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5424-020-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0215-2010;
18) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 13 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5424-020-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0216-2010;
19) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 16 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5424-020-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0217-2010;
20) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 19 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5424-020-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0218-2010;
21) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1 or 2, right, 9 MM height, for use with baseplate size 1, 2, sterile; REF 00-5424-021-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0219-2010;
22) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 11 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5424-021-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0220-2010;
23) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 13 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5424-021-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0221-2010;
24) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 16 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5424-021-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0222-2010;
25) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 19 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5424-021-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0223-2010;
26) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 9 MM height, for use with baseplate size 3, 4, or 5, sterile; REF 00-5424-023-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0224-2010;
27) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 11 MM height, for use with baseplate size 3, 4, or 5, sterile; REF 00-5424-023-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0225-2010;
28) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 13 MM height, for use with baseplate size 3, 4, or 5, sterile; REF 00-5424-023-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0226-2010;
29) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 16 MM height, for use with baseplate size 3, 4, or 5, sterile; REF 00-5424-023-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0227-2010;
30) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 19 MM height, for use with baseplate size 3, 4, or 5, sterile; REF 00-5424-023-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0228-2010;
31) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 9 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-010-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0229-2010;
32) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 11 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-010-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0230-2010;
33) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 13 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-010-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0231-2010;
34) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 16 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-010-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0232-2010;
35) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 19 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-010-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0233-2010;
36) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 9 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-011-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0234-2010;
37) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 11 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-011-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0235-2010;
38) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 13 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-011-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0236-2010;
39) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 16 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-011-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0237-2010;
40) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 19 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-011-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0238-2010;
41) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 9 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5428-013-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0239-2010;
42) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 11 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5428-013-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0240-2010;
43) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 13 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5428-013-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0241-2010;
44) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 16 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5428-013-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0242-2010;
45) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 19 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5428-013-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0243-201;
46) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 9 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-020-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0244-2010;
47) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 11 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-020-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0245-2010;
48) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 13 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-020-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Recall # Z-0246-2010;
49) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 16 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-020-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0247-2010;
50) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 19 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-020-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0248-2010;
51) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 9 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-021-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0249-2010;
52) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 11 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-021-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0250-2010;
53) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 13 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-021-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0251-2010;
54) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 16 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-021-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0252-2010;
55) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 19 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-021-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0253-2010;
56) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 9 MM height, for use with baseplate size 3,4 or 5, sterile; REF 00-5428-023-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0254-2010;
57) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 11 MM height, for use with baseplate size 3,4 or 5, sterile; REF 00-5428-023-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0255-2010;
58) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 13 MM height, for use with baseplate size 3,4 or 5, sterile; REF 00-5428-023-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0256-2010;
59) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 16 MM height, for use with baseplate size 3,4 or 5, sterile; REF 00-5428-023-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0257-2010;
60) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 19 MM height, for use with baseplate size 3,4 or 5, sterile; REF 00-5428-023-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0258-2010
MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letter dated October 8, 2009. Firm initiated recall is ongoing.
REASON: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.

PRODUCT:r> 1) GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL, 16 Slice and 6 Slice scanning device configurations. Model Numbers: 4535-679-71891 and 4535-6797591, 510(k) #K051170. Catalog Numbers: 882390 and 882410. Recall # Z-0260-2010;
2) GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI TF, 16, 64, and 16 Base Slice configurations, Model Numbers: 4535 679 83931, 4535 679 94741, and 4535-674 41711, 510(k) #K052640; Catalog Numbers: 882470, 882471, and 882473. Recall # Z-0261-2010
MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter on January 26, 2009. Firm initiated recall is complete.
REASON: Upper patient pallet component of the recalling firm's Gemini PET/CT system may be thinner than normally required which may reduce the product's load bearing capacity, resulting in cracking under less than the designed full-load weight.

PRODUCT: Intramedullary Skeletal Kinetic Distractor (ISKD) is an internal limb lengthening device consisting of a telescoping Internal Limb Lengthener, Locking Screws, Instrumentation and an external hand-held Monitor; catalog numbers: T10-215-265, T10-215-265NS, T10-255-305, T10-255-305NS, T10-255-335, T10-300-350, T10-300-350NS, T12-215-265, T12-245-295, T12-255-305, T12-255-305NS, T12-255-335, T12-300-350, T12-380-380, F12-255-305, F12-255-305NS, F12-255-335, F12-255-335NS, F12-300-350, F12-300-350NS, F12-300-380, F12-300-380NS, F12-345-395, F12-345-395NS, F12-345-425, and F12-345-425NS. Recall # Z-0262-2010
MANUFACTURER: Orthofix, Inc., McKinney, TX, by letter on October 9, 2009. Firm initiated recall is ongoing.
REASON: ISKD lengthening device has the potential for not pre-distracting.

PRODUCT: Norian CRS Rotary Mixer Cement 10cc sterile. Catalog number 614.10.01S. Recall # Z-0269-2010
MANUFACTURER: Synthes USA (HQ), Inc., West Chester, PA, by teleconference on September 14, 2009 and letter dated September 17, 2009. Firm initiated recall is ongoing.
REASON: Non-conforming material - increased set time. Potential clinical ramifications associated with increased set time and decreased strength includes extrusion of unset material and fragmentation of cured material. The risk of Norian fragmentation post cure increases with a larger defect and a thicker layer of product.

PRODUCT: Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, sterile; REF 35-351534. Internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. The devices can also be used as instrument accessories to stabilize cut blocks and can serve as guide wires while using reamers. Recall # Z-0367-2010
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated August 6, 2009. Firm initiated recall is ongoing.
REASON: Packages labeled as having a .045 inch diameter trocar point actually contain a diamond point with a diameter of .062 inches.

PRODUCT:
1) Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part Numbers: D-1257-01 & D-1257-02. Recall # Z-0368-2010;
2) Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02. Recall # Z-0369-2010
MANUFACTURER: Recalling Firm: BioSense Webster, Inc., Chihuahua, Mexico, by letter on October 6, 2008. Manufacturer: BioSense Webster, Inc., Irwindale, CA. Firm initiated recall is complete.
REASON: Biosense Webster reported that one of the Printed Circuit Board (PCB) components used in the NAVISTAR (R) RMT Catheters, may cause the ablation catheter icon to shift on the map viewer when RF energy is being applied. The icon then returns to the correct position after the RF application is stopped. However, this movement is only observed on the map viewer and there is no actual movement of the catheter tip. Testing indicates that for shifts of less than approximately 25mm, there is no display of an error message or any other indication that the CARTO RMT System/catheter is malfunctioning and therefore, the user, attempting a linear ablation in the location displayed on the CARTO RMT screen, may ultimately apply RF energy to an unintended locations. This would only be applicable for lesions being created during a linear ablation and would not apply to a focal lesion ablation since the icon returns to the true position between RF applications and location is typically verified using the ECG. This condition does not impact any other ancillary visualization equipment. A shift in the ablation catheter icon can be detected by paying close attention to the location of the ablation catheter icon on the map viewer when applying RF energy. Consistent with the CARTO (R) RMT System manual, it is also recommended to check the position of the catheter by observing the electrograms prior to applying RF energy.

PRODUCT: Zimmer Dynesys top-loading cutter, spacer; REF 07.01284.001. Recall # Z-0370-2010
MANUFACTURER: Recall # Zimmer Inc., Warsaw, IN, by letter dated May 20, 2009.
Manufacturer: Zimmer Spine, Inc., Minneapolis, MN. Firm initiated recall is ongoing.
REASON: The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay.

PRODUCT: Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603. Recall # Z-0389-2010
MANUFACTURER: Smith & Nephew, Inc., Memphis, TN, by letter on January 23, 2009. Firm initiated recall is ongoing.
REASON: Radius at the end of the taper of the femoral implant is smaller than specification. This error could result in the tapers not locking fully or properly on femoral stems or in causing impingement and/or increased wear debris. The deficiency may not be noticed by the user. Impingement and/or wear debris may lead to revision.

PRODUCT:
1) AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) Part Number 72201714. The product is an orthopedic device. Recall # Z-0415-2010;
2) AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an orthopedic device. Recall # Z-0416-2010;
3) AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an orthopedic device. Recall # Z-0417-2010
MANUFACTURER: Smith & Nephew, Inc., Endoscopy Div., Mansfield, MA, by letter on September 3, 2009. Firm initiated recall is ongoing.
REASON: Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.

PRODUCT: Philips Lifeline Personal Help Button Pendant Classic and Slimline Style. Recall # Z-0419-2010
MANUFACTURER: Philips Lifeline, Inc., Farmingham, MA, by letters on September 21, 2009. Firm initiated recall is ongoing.
REASON: Pendant Personal Help Button neck cord may not break away and if not will present a potential choking risk.

PRODUCT: Kuschall K Junior Manual wheelchair. Model Numbers: 0806281234, 0806893858, 0806135534, 0806161578, 0806237627, 0806268153, 0806268154, 0806309590, 0806315524, 0806351557, 0806568768, 0806591793. 0806670117, 0806724855, 0806731287, 0806773921, 0807007811, 0807019897, 0807062866, 0807110193. Recall # Z-0421-2010
MANUFACTURER: Recalling Firm: Invacare Corp., Elyria, OH, by telephone and letter on June 15, 2009. Manufacturer: Kuschall Design AG, Allschwil, Switzerland. Firm initiated recall is ongoing.
REASON: The handle has been breaking at a calculated weight of 65kg which may have serious consequences (broken bones) depending on the circumstances of the break (e.g., user on ramps, hills, etc.).

PRODUCT:
HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P060040) and the HeartMate XVE LVAS (PMA P920014) Systems. The HeartMate II and the HeartMate XVE LVAS are intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate XVE LVAS is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days and who are not candidates for cardiac transplantation. The HeartMate II and XVE LVAS are intended for use both inside and outside the hospital, for transportation of Ventricular Assist Device (VAD) patients via ground ambulance, fixed-wing aircraft or helicopter. The devices consist of an implantable blood pump connected to an external System Controller by a percutaneous lead. The external controller is powered by AC electrical power, via the Power Module or Power Base Unit, or by battery power with a pair of rechargeable HeartMate batteries. Two batteries are used simultaneously for power. The LVAS is also designed to operate on a single battery, facilitating battery changes without interruption of VAD support. Recall # Z-0422-2010
MANUFACTURER: Thoratec, Corp., Pleasanton, CA, by letter dated October 14, 2009. Firm initiated recall is ongoing.
REASON: Patient reports alerted Thoratec that during the process of disconnecting power leads from the battery clips, the threaded connector of the battery clip housing was observed to be loose, and in some cases dislodged from the battery clip housing. The problem affects HeartMate 12V SLA Battery Clips including those used for the HeartMate II LVAS and HeartMate XVE systems. If not detected and handled correctly, this may interfere with the ability to connect the system to a power source, and subsequently to interrupt pump function.

PRODUCT: Tornier, LMP-50 (Lesser Metatarsal Phalangeal Implant), Size 50, Sterile EO. The Lesser Metatarsal Phalangeal Joint Implant is indicated for: Partial or complete dislocation of the lesser metatarsophalangeal joint. Recall # Z-0455-2010
MANUFACTURER: Recall Firm: Tornier, Inc., Edina, MN, by letter dated April 3, 2009. Manufacturer: Kinamed Inc., Camarillo, CA. Firm initiated recall is ongoing.
REASON: Mislabeled product due to a product mix-up. The package label indicated that the product was a model LMP-50 however the product inside the package was Tornier FGT-50 implant (Primus Flexible Great Toe Implant With Grommetts).

PRODUCT: GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment. Recall # Z-0456-2010
MANUFACTURER: GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated September 23, 2009. Firm initiated recall is ongoing.
REASON: There are potential safety issues, including misdiagnosis or delay in treatment, associated with the use of GE Centricity PACS RA1000 Workstation software that may impact patient safety.

PRODUCT: Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bluetooth Wireless Technology. Recall # Z-0458-2010
MANUFACTURER: Nonin Medical, Inc., Plymouth, MN, by on October 23, 2009. Firm initiated recall is ongoing.
REASON: A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the POD. This overheating, while unlikely to occur, has the potential to cause a burn if the POD is in direct contact with the patient.

PRODUCT:
1) Bath Safe Adjustable Shower Seat, Without Back and Arms, Catalog number 727142001. Recall # Z-0459-2010;
2) Bath Safe Adjustable Shower Seat, With Arms, Model numbers 727142020, 727142021, and MDS89750R. Recall # Z-0460-2010;
3) Bath Safe Adjustable Shower Seat, With Back, Catalog number 727142101. Recall # Z-0461-2010;
4) Bath Safe Adjustable Shower Seat, With Arms and Back, Catalog numbers 727142120, 727142121, 727142124, and MDS89755R. Recall # Z-0462-2010;
5) Bath Safe Adjustable Transfer Bench, Catalog numbers 727142500, 727142501, and MDS86960R. Recall # Z-0463-201;
6) Shower Seat, Non-rotating, Catalog number 727152000. Recall # Z-0464-2010;
7) Shower Seat, Rotating, Catalog number 727152100. Recall # Z-0465-2010
MANUFACTURER: Nutech Manufacturing Corp., Pocomoke City, MD, by letter, telephone and e-mail on July 9, 2009. Firm initiated recall is ongoing.
REASON: Safety chair used in shower/bath may not meet specifications for weight load.

PRODUCT: Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories. Recall # Z-0480-2010
MANUFACTURER: Recalling Firm: Maquet, Inc., Bridgewater, NJ, by letters on October 22, 2009. Manufacturer: Maquet Aktiengesellschaft, Rastatt, Germany. Firm initiated recall is ongoing.
REASON: Product monitoring has determined that the connection bracket shows potential mechanical play at the OR table interface for some procedures. This is due to the hole in the lock washer, which is responsible for locking the accessory to the OR table, being too large.

PRODUCT: TempSpan Dual-Cure Temporary Crown and Bridge Material, Part number N69AD, The intended use of this device is to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. Recall # Z-0482-2010
MANUFACTURER: Jeneric/Pentron, Wallingford, CT, by letter on October 22, 2009. Firm initiated recall is ongoing.
REASON: Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary Crown and Bridge Material was not setting. Investigation of product in inventory was conducted and it was confirmed that some of the bottles had been mispackaged with an incorrect catalyst.

PRODUCT: 1) Axiom Artis MP, Model number 5904466 angiographic x-ray systems. Recall # Z-0483-2010; 2) Axiom Artis dMP, Model number 7555365 angiographic x-ray systems. Recall # Z-0484-2010; 3) Axiom Artis Zee Multi-purpose, Model number 10094139 angiographic x-ray systems. Recall # Z-0485-2010
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on October 27, 2009. Manufacturer: Siemens Medical Solutions, Inc., Erlangen, Germany. Firm initiated recall is ongoing.
REASON: C-arm may tilt.

PRODUCT: Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002. Recall # Z-0488-2010
MANUFACTURER: Sybronendo, Orange, CA, by letter on November 06, 2009. Firm initiated recall is ongoing.
REASON: The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability required, and therefore, may not withstand the pressures exhibited by the Elements Obturation Unit with which the cartridges are used. More specifically, there exists a possibility that if the lock nut were to fail, the cartridge could fall out onto patients or users and could cause a burn.

PRODUCT: Zodiac Polyaxial Spinal Fixation System. Part Number: 62665-50. Recall # Z-0491-2010
MANUFACTURER: Alphatec Spine, Inc., Carlsbad, CA, by telephone on October 16, 2008. Firm initiated recall is complete.
REASON: Alphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. As a result, they are conducting a voluntary recall of the Zodiac Titanium cannulated polyaxial screw 6.5 mm x 50 mm L.

PRODUCT: ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520. The ILLICO Posterior Thoracolumbar Access Retractor is an instrument that is intended for use in a minimally invasive approach for surgical procedures. The retractor allows retraction of tissue through combination of articulating blades. Device will serve to provide access for surgeons to surgical site. Recall # Z-0498-2010
MANUFACTURER: Alphatec Spine, Inc., Carlsbad, CA, by telephone on January 28, 2009. Firm initiated recall is complete.
REASON: The recall was initiated after Alphatec Spine received a complaint on the ILLICO Posterior Thoracolumbar access retractor. It was reported that one of the retractor arms in the retractor broke during surgery.

PRODUCT: Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile; REF AVACT. Recall # Z-0499-2010
MANUFACTURER: Recalling Firm: Zimmer, Inc., Warsaw, IN, by telephone on or about November 6, 2009. Manufacturer: Zimmer Dental, Inc., Carlsbad, CA. Firm initiated recall is complete.
REASON: The devices may not meet specifications, which may result in fracturing during tightening of the component.

PRODUCT: Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile, REF 904842P. Intended to be implanted for fixation of bone fractures and for bone reconstructions. Recall # Z-1091-2010
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated September 9, 2009.
Manufacturer: Biomet sports Medicine, Inc., Ontario, CA. Firm initiated recall is ongoing.
REASON: These anchors may be difficult to remove, or may not detach from the inserter shaft.

CLASS III

PRODUCT: 1) Advance (R) Canal Filling Stem Extension, REF: KSP1-2140, Diameter 11mm, Length 140mm, 1 each, Sterile R, (For use with cement only), Single Use Only, (Ti6A14V). Recall # Z-0492-2010; 2) Advance (R) Canal Filling Stem Extension, REF: KSP1-2140, Diameter 13mm, Length 140mm, 1 each, Sterile R, (For use with cement only), Single Use Only, (Ti6A14V). Recall # Z-0493-2010
MANUFACTURER: Wright Medical Technology, Inc., Arlington, TN, by telephone on September 22, 2009 and letters dated October 9, 2009. Firm initiated recall is complete.
REASON: Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy segregation, primary alpha and/or a transformed beta matrix in some of the heat lots. The absence of alloying elements results in an area with less strength. For those instances where the product has been implanted, there is the potential increased risk of failure for these patients.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 11, 2009:

CLASS II

PRODUCT: Cyberonics VNS Therapy Demipulse Generator Model 250 Programming System, version 4.6, 6.1, 7.0, and 7.1 labeling, for vagus nerve stimulation. Recall # Z-0264-2010
MANUFACTURER: Cyberonics, Inc., Houston, TX, by letter on July 24, 2009. Firm initiated recall is ongoing.
REASON: Failure to deliver therapy. Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test using Model 250 Programming Software (versions 7.1 and earlier) may report "Lead Impedance: OK" when a short-circuit condition exists that prevents the lead from delivering therapy to the vagus nerve.

PRODUCT:
1) Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmonary digital assembly kit and Pulmonary toolkit oncology Pro available on the following GEMINI PET/CT systems: GEMINI GXL 16 slice configuration, Model Number: 4535 679 75691. Recall # Z-0286-2010;
2) Respiratory Gating System, Catalog Number: NPTA540, Model #4535 674 26701, for the following affected CT/PET scanning device systems : GEMINI TF CT/PET Systems 16 Slice, GEMINI TF CT/PET System 16 Slice Mobile; GEMINI TF CT/PET System 64 Slice Mobile; and GEMINI TF CT/PET System 64 Slice. Model Numbers: 16 slice: 4535 679 83931; 64 slice Mobile: 4535 674 47551; and 64 slice: 4535 679 94741. Recall # Z-0287-2010
MANUFACTURER: The Philips Medical Systems (Cleveland), Cleveland, OH, by letter on November 24, 2009. Firm initiated recall is ongoing.
REASON: A leak between the Tube Interface and the Outlet Tube of the transducer for the Respiratory Gating System component may result in a failure of the device to produce respiratory correlated images.

PRODUCT: PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems. Recall # Z-0365-2010
MANUFACTURER: Picis Inc., Wakefield, MA, by letter on April 8th 2009. Firm initiated recall is ongoing.
REASON: Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between non-Picis clinical systems (your "HIS" or "CIS") and certain Picis applications, if that interface is not configured properly.

PRODUCT: 1) Stryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component. Catalog number 6260-5-326. Recall # Z-0390-2010;
2) Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component. Catalog number 6260-9-132. Recall # Z-0391-2010
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on September 4, 2009 and September 9, 2009. Manufacturer: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.
REASON: Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.

PRODUCT: Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical labels: (1) Prentice PICC Kit, Catalog number K12T-03698; (2) Insertion Kit, catalog number K12T-03050C; and (3) Angio Procedure Pack, catalog number K09T-09530A. Recall # Z-0413-2010
MANUFACTURER: Merit Medical Systems, Inc., Chester, VA, by telephone, fax or visit on May 19, 2009. Firm initiated recall is complete.
REASON: Surgical gloves in hospital convenience kits may be degraded and tear during use.

PRODUCT: The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Phototherapy System". Catalogue / Part Numbers: 010101 (110V, US, new); 010101R (110V, US, refurbish); 010102 (230V, UK, new); 010102R (230V, UK, refurbish); 010103 (230V, EUR, new); 010103R (230V, EUR, refurbish); 010104 (230V, EUR, new); 010104R (230V, EUR, refurbish). Recall # Z-0420-2010
MANUFACTURER: Natus Medical Incorporated, Seattle, WA, by letter on October 1, 2009. Firm initiated recall is ongoing.
REASON: The clamp connecting the neoBLUE mini phototherapy light to the accessory pole stand can sustain stress fractures or break when excessive force is used when tightening the clamp. No injuries have been reported.

PRODUCT:
1) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 22MM, spinal implant component. Catalog Number 48036022. Recall # Z-0423-2010;
2) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 25MM, spinal implant component. Catalog number 4803625. Recall # Z-0424-2010;
3) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 28MM, spinal implant component. Catalog number 48036028. Recall # Z-0425-2010;
4) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 31MM, spinal implant component. Catalog number 48036031. Recall # Z-0426-2010;
5) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 34MM, spinal implant component. Catalog number 48036034. Recall # Z-0427-2010;
6) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 37MM, spinal implant component. Catalog number 48036027. Recall # Z-0428-2010;
7) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 40MM, spinal implant component. Catalog number 48036040. Recall # Z-0429-2010;
8) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 43MM, spinal implant component. Catalog number 48036043. Recall # Z-0430-2010;
9) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 46MM, spinal implant component. Catalog number 48036046. Recall # Z-0431-2010;
10) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 49MM, spinal implant component. Catalog number 48036049. Recall # Z-0432-2010;
11) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 52MM, spinal implant component. Catalog number 48036052. Recall # Z-0433-2010;
12) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 55MM, spinal implant component. Catalog number 48036055. Recall # Z-0434-2010;
13) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 58MM, spinal implant component. Catalog number 48036058. Recall # Z-0435-2010;
14) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 61MM, spinal implant component. Catalog number 48036061. Recall # Z-0436-2010;
15) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 64MM, spinal implant component. Catalog number 48036064. Recall # Z-0437-2010;
16) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 67MM, spinal implant component. Catalog number 48036067. Recall # Z-0438-2010;
17) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 22MM, spinal implant component . Catalog number 48036522. Recall # Z-0439-2010;
18) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 25MM, spinal implant component. Catalog number 48036525. Recall # Z-0440-2010;
19) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 28MM, spinal implant component. Catalog number 48036528. Recall # Z-0441-2010;
20) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 31MM, spinal implant component. Catalog number 48036531. Recall # Z-0442-2010;
21) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 34MM, spinal implant component. Catalog number 48036534. Recall # Z-0443-2010;
22) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 37MM, spinal implant component. Catalog number 48036537. Recall # Z-0444-2010;
23) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 40MM, spinal implant component. Catalog number 38036540. Recall # Z-0445-2010;
24) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 43MM, spinal implant component. Catalog number 48036543. Recall # Z-0446-2010;
25) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 46MM, spinal implant component. Catalog number 48036546. Recall # Z-0447-2010;
26) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 49MM, spinal implant component. Catalog number 48036549. Recall # Z-0448-2010;
27) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 52MM, spinal implant component. Catalog number 48036552. Recall # Z-0449-2010;
28) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 55MM, spinal implant component. Catalog number 48036555. Recall # Z-0450-2010;
29) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 58MM, spinal implant component. Catalog number 48036558. Z-0451-2010;
30) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 61MM, spinal implant component. Catalog number 48036561. Recall # Z-0452-2010;
31) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 64MM, spinal implant component. Catalog number 48036564. Recall # Z-0453-2010;
32) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 67MM, spinal implant component. Catalog number 48036567. Recall # Z-0454-2010
MANUFACTURER: Recalling Firm: Stryker Spine, Allendale, NJ, by letters on October 19, 2009. Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is ongoing.
REASON: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break at the tip.

PRODUCT: Cargille Modified Kingsbury-Clark Albumin Standards For in vitro Diagnostics (Set of 8 Standards: 5, 10, 20, 30, 40, 50, 75, 100 mg/ml); Catalog number: 52064. Recall # Z-0479-2010
MANUFACTURER: Cargille-Sacher Laboratories, Inc., Cedar Grove, NJ, by letters on July 7, 2006. Firm initiated recall is complete.
REASON: The 10 ml size standard of Cargille modified Kingsbury Clark Albumin Standards of lot Jan-12-05 appear shrunken or liquefied.

PRODUCT: ezManager Max Diabetes Management System version 2.0.9. Recall # Z-0481-2010
MANUFACTURER: Animas Corp., West Chester, PA, by letter dated November 2, 2009. Firm initiated recall is ongoing.
REASON: Printed hard copy of results is not the same as the system screens-carbohydrate to insulin ratio incorrect.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 2, 2009:

CLASS II
PRODUCT:
1) Medtronic Concerto, C154DWK, Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy, atrial and ventricular therapies. Recall # Z-0126-2010;
2) This device is not approved in the United States. Medtronic Concerto, C174AWK. Dual Chamber implantable cardioverter defibrillator with cardiac resynchronization therapy, atrial and ventricular therapies. Recall # Z-0127-2010;
3) Medtronic Virtuoso DR, D154AWG, Dual Chamber implantable cardioverter defibrillator with atrial and ventricular therapies. This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure. In addition, the device is indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. Recall # Z-0128-2010;
4) Medtronic Virtuoso VR, Model D154VWC, Single Chamber implantable cardioverter defibrillator with atrial therapies. This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure. Recall # Z-0129-2010;
5) This device is not approved in the United States. Medtronic Virtuoso DR, D164AWG. Recall # Z-0130-2010;
6) This device is not approved in the United States. Medtronic Virtuoso VR, D164VWC. Recall # Z-0131-2010
MANUFACTURER: Recalling Firm: Medtronic Inc., Cardiac Rhythm Disease Management, Saint Paul, MN, by letter dated September 9, 2009 and September 28, 2009. Manufacturers: Medtronic Swiss Manufacturing Facility, Tolochenaz, Switzerland and Medtronic Puerto Rico Operations Company (MPROC), Juncos, Puerto Rico. Firm initiated recall is ongoing.
REASON: A subset of active implanted Concerto CRT-D and Virtuoso ICD devices worldwide (estimated at 6,300) may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the Recommended Replacement Time (RRT) earlier than projected. This issue does not compromise device functionality or affect therapy delivery. Medtronic expects that affected devices will continue to provide at least three months of normal device function between RRT and End of Service (EOS) as described in device labeling.

PRODUCT: Bausch & Lomb ReNu Multi-Purpose Solution, 12 fl. oz. (355 ml). Product is used for the cleaning, rinsing, disinfecting, and storage of soft contact lenses. Recall # Z-0159-2010
MANUFACTURER: Recalling Firm: Bausch & Lomb, Inc., Rochester, NY, by letter on/about August 17, 2009. Manufacturer: Bausch & Lomb, Inc., Greenville, SC. Firm initiated recall is ongoing.
REASON: During routine testing the product failed to meet shelf life specifications.

PRODUCT: * (Box label) Suction Coagulator 10FR Qty 25 ***** * (Pouch label) Ultraclean TM Foot Controlled Suction Coagulator 10 FR Qty: 1 ** Sterile ***** Made in China. Recall # Z-0165-2010
MANUFACTURER: Recalling Firm: ConMed Electrosurgery, Centennial, CO, by telephone from September 30 – October 1, 2009 and by letter dated September 30, 2009. Manufacturer: Modern Metal & Electric Ltd., Kwai Chung, Hong Kong SAR. Firm initiated recall is ongoing.
REASON: One production lot of Suction Coagulators received ETO sterilization instead of gamma radiation sterilization.

PRODUCT:
1) Koordinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as an Angiographic X-Ray System. Recall # Z-0166-2010;
2) Koordinat M/MP Patient Table used with Multistar Model 6239003. The device is used as an Angiographic X-Ray System. Recall # Z-0167-2010
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated July 1, 2009. Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany. Firm initiated recall is ongoing.
REASON: The table swivel locking mechanism may not completely engage and could result in uncontrolled patient movement during transfer resulting in a patient fall.

PRODUCT: Gynecare Morcellex Tissue Morcellator. a) Product Code: MX0100 Hand Piece - 5 pack; b) Product Code: MX0100R- single. Recall # Z-0173-2010
MANUFACTURER: Ethicon, Inc., Somerville, NJ, by letters on October 8, 2009. Firm initiated recall is ongoing.
REASON: There is the potential for the duckbill seal to become dislodged.

PRODUCT: Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license. a) Model number 7502029, b) Model number 10496279. Recall # Z-0174-2010
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated September 14, 2009. Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany. Firm initiated recall is ongoing.
REASON: Incomplete amount of image data; specifically, the image count in the series table of the online and archive database will display the full amount of images received at the Syngo Imaging XS as archived. However, the zip file on the NAS or HSM will contain fewer images-those which have been archived until the time of the error/interruption

.PRODUCT: Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model no. 840-700K, or Swiss LithoClast Ultra Upgraded System model no. 840-701U, compatible with 330mm Ultrasound Probes (REF 840-714 and 840-715), Rx, sterile, no detectable latex; REF/catalog no 840-733. Recall # Z-0175-2010
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Spencer, IN, by letter dated September 17, 2009. Manufacturer: EMS SA, Nylon, Switzerland. Firm initiated recall is ongoing.
REASON: The label incorrectly reads "compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)" instead of bearing the correct statement "compatible with 403mm ultrasound probes (Ref 840-716 and 840-7170).

PRODUCT: Respironics V60 Ventilator. Recall # Z-0176-2010
MANUFACTURER: Respironics California, Inc., Carlsbad, CA, by letter on October 26, 2009. Firm initiated recall is ongoing.
REASON: The recall was initiated to correct an issue with a component on the V60 Ventilator Power Management (PM) Printed Circuit Board (PCB). A component on the PCB has the potential to break off or become damaged if the PCB is removed from the ventilator. If this occurs, the ventilator may not properly switch between back up battery power and AC power. This can result in power loss during ventilation followed by the annunciation of the back up alarm and the display of a red Alarm LED during the following conditions: (1) During transport with the optional back up battery, (2) If there is an interruption of power caused by mains power loss, (3) Inadvertent disconnection of the power cord.

PRODUCT: System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; The Hemodialysis and Continuous Renal Replacement Therapy devices are used for acute and chronic hemodialysis, including high flux hemodialysis. The device is intended for use by trained operators when prescribed by a physician. The device is intended to be used with hollow fiber or parallel plate dialyzers. Recall # Z-0179-2010
MANUFACTURER: Recalling Firm: Baxter Healthcare Renal Division, McGaw Park, IL, by letter dated August 31, 2009. Manufacturer: Baxter Healthcare Corp., Largo, FL. Firm initiated recall is ongoing.
REASON: When the main power is lost temporarily, a software anomaly prevents the instrument from automatically changing the ultra filtration rate (UFR) to the minimum value as described in the Operator's manual.

PRODUCT:
Guidant LATITUDE Communicator, model 6481. The LATITUDE Patient Management system enables physicians to periodically monitor both patient and device status remotely. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. Recall # Z-0180-2010
MANUFACTURER: Recalling Firm: Boston Scientific CRM Corp., Saint Paul, MN, by telephone beginning August 6, 2009 and August 17, 2009. Manufacturer: Benchmark Electronics Inc., Winona, MN. Firm initiated recall is ongoing.
REASON: The LATITUDE communicator (Model 6481) for a patient may not have been able to receive measurements from their weight scale or blood pressure monitor after initial setup. The issue has been resolved. If any patient weight or blood pressure readings are stored in the patient's sensor, they will be uploaded to LATITUDE after the patient's communicator calls in to Boston Scientifics servers. It may take up to 8 days for readings from the weight scale or blood pressure sensors to appear in LATITUDE. Physicians should note the timestamps on the sensor readings or weight alerts before basing any patient management decisions on this information.

PRODUCT: Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621. Recall # Z-0263-2010
MANUFACTURER: Recalling Firm: Stryker Instruments Div. of Stryker Corp., Kalamazoo, MI, by letter dated October 5, 2009. Manufacturer: Orchid Unique, Bridgeport, MI. and Stryker Ireland, Ltd. - Instruments Division, Carrigtwohill, County Cork, Ireland. Firm initiated recall is ongoing.
REASON: The cross-cuts are missing on the device, which will result in poor cutting and overheating and/or smoking of the device.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 25, 2009:

CLASS I
PRODUCT:
1) Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # a) 5801, b) 12-8713, c) 732-E, and d) 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned. Recall # Z-0039-2010;
2) Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: a) 5804; b) 12-8709, c) 727-E; d) 727MM, e) 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recall # Z-0040-2010;
3) Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # a) 5807; b) 12-8703, c) 723-E (Foreign Distribution only), d) 723MM. Packaged under the name of Dynarex and Evergreen. Recall # Z-0041-2010;
4) Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s a) 5808, b) 12-8704; c) 724-E; d) 724MM, e) 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products. Recall # Z-0042-2010;
5) Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distribution only), 721MM. Packaged under the name of Evergreen, Hospitak, Kentron, McKesson and Mada. Recall # Z-0043-2010;
6) Manual Pulmonary Resuscitator, Adult w/ Large Adult Mask & Reservoir Bag. Product # 12-8705. Packaged under the name of Evergreen. Recall # Z-0044-2010;
7) Pediatric Manual Pulmonary Resuscitator w/Luer-lock Sampling Elbow & Reservoir bag (No mask). Product ID# 12-8707. Packaged under the name of Evergreen. Recall # Z-0045-2010;
8) Pediatric Manual Pulmonary Resuscitator. Product ID # 12-8708. Packaged under the name of Evergreen. Recall # Z-0046-2010;
9) Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID # 12-8710, 726-E; 86-722E, 726MM. Packaged under the name of Evergreen, Hospitak, and McKesson. Recall # Z-0047-2010;
10) Infant Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas sampling elbow. Product ID # 12-8714; 731-E, 731MM; 86-731E. Packaged under the name of Evergreen, Hospitak and McKesson. Recall # Z-0048-2010;
11) Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & standard elbow. Product ID # 722-E, 86-722-E; 722MM. Packaged under the name of Hospitak and McKesson. Recall # Z-0049-2010;
12) Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas Sampling Elbow. Product ID #: 728-E. Recall # Z-0050-2010;
13) Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off 40 Cm H2O Elbow. Product ID #s: 729-E; 40-116730; Foreign distribution only; 729MM. Recall # Z-0051-2010;
14) Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow. a) Product ID # 730-E; Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow, b) Product ID # 730MM. Recall # Z-0052-2010;
15) Manual Pulmonary Resuscitator with reservoir tube and Peep Valve. Product ID #s 742-E; 86-742E. Packaged under the name of Hospitak, McKesson. Recall # Z-0053-2010;
16) Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 Cm H2O Elbow. a) Product ID # 735-E; Distributed in France only: b) product code: 40-116735. Recall # Z-0054-2010;
17) Hospitak Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel gas sampling elbow. Foreign distribution only. Product code: 725-E. Recall # Z-0055-2010;
18) Drager Medical Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and swivel gas sampling elbow, Peep Valve. Product code: 40-116733, Distribution to France only. Recall # Z-0056-2010;
19) Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas sampling elbow. Foreign Distribution only: Product number 733-E. Recall # Z-0057-2010;
20) Hospitak Infant Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off 40 cm H2O Elbow. Foreign distribution only: Product codes: 734-E, 734MM. Recall # Z-0058-2010;
21) Unomedical Adult Manual Pulmonary Resuscitator, Adult Medium Mask w/ Reservoir Bag. Product ID # 779725. Recall # Z-0070-2010;
22) Unomedical Pediatric Manual Pulmonary Resuscitator, Child Mask & Reservoir Hose, Product ID # 779728. Recall # Z-0071-2010;
23) Unomedical Infant Manual Pulmonary Resuscitator, Infant Mask & Reservoir Hose. Product ID # 779733. Recall # Z-0072-2010
MANUFACTURER: Recalling Firm: Unomedical, McAllen, TX, by press release on October 6, 2009 and by letters on October 7, 2009. Manufacturer: Unomedical S.A. de C.V., Reynosa, Mexico. Firm initiated recall is ongoing.
REASON: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary to ventilate the patient.

PRODUCT: Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. The Cordis CROSSOVER Sheath Introducer is intended for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids. a) Catalog Number: 403545S; Catalog Number: 403585S; Catalog Number: 403645S; d) Catalog Number: 403685S; e) Catalog Number: 403745S; f) Catalog Number: 403785S, Recall # Z-0087-2010
MANUFACTURER: Recalling Firm: Cordis Corp., Miami Lakes, FL, by letter dated October 19, 2009. Manufacturer: Thomas Medical Products, Inc., Malvern, PA. Firm initiated recall is ongoing.
REASON: Complaints of stretching or fracture of the sheath shaft during use.

CLASS II
PRODUCT: Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head. a) Part 133-2846, b) Part 133-2847; c) Part 133-2848; d) Part 133-2851; e) Part 133-2852. Recall # Z-0086-2010
MANUFACTURER: Ortho Development Corp., Draper, UT, by Memo dated April 2, 2009 and by telephone on April 29, 2009. Firm initiated recall is ongoing.
REASON: A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances.

PRODUCT: Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited. Recall # Z-0119-2010
MANUFACTURER: Cochlear Americas, Inc, Englewood, CO., by letter on September 28, 2009. Firm initiated recall is ongoing.
REASON: Cochlear implant device component was mislabeled.

PRODUCT: VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Recall # Z-0133-2010
MANUFACTURER: Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on September 15, 2009. Firm initiated recall is ongoing.
REASON: Software issue: Under certain circumstances, when a therapy treatment field is transferred to VARiS Vision 6.2, 6.1 and 6.0 via LINK procedures, the rotation direction will be reversed.

PRODUCT:
1) GE Healthcare, GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector), Recall # Z-0135-2010;
2) GE Healthcare, GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Recall # Z-0136-2010;
3) GE Healthcare, GE Innova 4100 / 4100 IQ. , (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Recall # Z-0137-2010;
4) Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging System. Recall # Z-0138-2010
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated April 16, 2009. Manufacturer: GE Medical Systems, SCS, Bue Cedex, France. Firm initiated recall is ongoing.
REASON: Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the X-ray is inhibited. This could lead to a delay in treatment and possible additional X-ray exposure and contrast media when examination is resumed on other equipment.

PRODUCT: John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube. Recall # Z-0139-2009
MANUFACTURER: Recalling Firm: GF Health Products, Inc., Atlanta, GA, by letter on/about September 14, 2009. Manufacturer: Fine Surgical Corp., Hempstead, NY. Firm initiated recall is ongoing.
REASON: Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications.

PRODUCT: Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8" (13.7 cm), catalog # OS5000-005, sold separately, or as a component of the Craig Vertebral Biopsy Set, catalog # OS5000. Recall # Z-0141-2010
MANUFACTURER: Recalling Firm: Cardinal Health, Mc Gaw Park, IL, by letters dated August 28, 2009. Manufacturer: Cardinal Health, Medical Products & Services Div., Maplewood, MO. Firm initiated recall is ongoing.
REASON: The Craig Calibrated Cannula does not interface with the toothed cutter properly, which may prevent the toothed cutter from properly advancing through the cannula to the biopsy site.

PRODUCT:
1) Power cord for Model 3300 Cardiac Output Computer, List # 41245-04-03. AC power cords, all units of Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, 826-96057-003. Recall # Z-0142-2010;
2) Power cord for Optional Thermal Printer (For use with Model 3300 COC), Oximetrix 3 SO2/CO Computer, Q-Vue CCO Computer and Q2 CCO/SO2 Computer, List Number 50132-04-05, AC power cords, all units of Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, 826-96057-003. Recall # Z-0143-2010;
3) Power cord for Oximetrix 3 SO2/CO Cardiac Output Computer, list # 50130-04-07, AC power cords, all units of Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, 826-96057-003. Recall # Z-0144-2010;
4) Power cord for Q2 Continuous Cardiac Output (CCO)/SO2 Computer, list #s 52235-04-01, 52235-04-03, 52236-04-05, 52235-04-07, 52235-04-11, AC power cords, all units of Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, 826-96057-003. Recall # Z-0145-2010;
5) Power cord for Q2Plus/Continuous Cardiac Output (CCO)/SO2 Computer, list #s 56711-04-01, 56711-04-03, 5671-04-05, 56711-04-51. AC power cords, all units of Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, 826-96057-003. Recall # Z-0146-2010;
6) Power cord for QVue Continuous Cardiac Output (CCO)/SO2 computer, list #s 52230-04-03, 52230-04-05, 52230-04-07, 52230-04-09, 52230-04-11, 52230-04-13, 52230-04-15, 52230-04-17, 52230-04-25, 52230-04-31, 52230-04-33. AC power cords, all units of Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, 826-96057-003. Recall # Z-0147-2010
MANUFACTURER: Hospira, Inc., Morgan Hill, CA, by press release and letter on August 14, 2009. Firm initiated recall is ongoing.
REASON: Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock hazard.

PRODUCT: 1) Stryker Medical Stair-PRO Stair Chair with wheels, patient transport device, Model 6251. Recall # Z-0148-2010;
2) Stryker Medical Stair-PRO Stair Chair with wheels and a track system, patient transport device, Model 6252. Recall # Z-0149-2010
MANUFACTURER: Stryker Medical Div. of Stryker Corp., Portage, MI, by letter dated September 9, 2009. Firm initiated recall is ongoing.
REASON: The front of the handle may become detached from the chair, which could result in a patient fall or an operator injury.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 18, 2009:

CLASS II
PRODUCT:
1) GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Recall # Z-1706-2009;
2) Sterile, Drape, Headset, Upper, Part Number 888945-01. Recall # Z-1708-2009;
3) Sterile, Drape, Headset, Upper, Part Number 888945-01. Recall # Z-1708-2009;
4) Disposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01, Sterile, Drape, Headset, Lower and Part Number 888945-01, Sterile, Drape, Headset, Upper). Recall # Z-1709-2009
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated August 15, 2008. Manufacturer: Contour Fabricators Inc., Fenton, MI. Firm initiated recall is ongoing.
REASON: Products may have seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state.

PRODUCT: Broselow/Hinkle Pediatric Emergency System; Contents: 1 15 Ga Adjustable Length Sternal/Iliac aspiration Needle; 1 Extension Set, Sterile. Equipment Color Zone: Green, Single Patient use, INTRAOSSEUS Module, Product # 7700GIO, The Broselow/Hinkle Pediatric Emergency System is a convenience kit that contains various modules/components used for the emergency treatment of pediatric patients. The modules are color coded to accommodate patients of various sizes. Model Numbers: 7700BIO, 7700GIO, 7700PIO, 7700RIO, 7700WIO, 7700YIO, 7700BIO2, 7700GIO2, 7700OIO2, 7700PIO2, 7700RIO2, 7700WIO2, 7700YIO2, 7730BLU5, 7730GRN5, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5, 7730FLY, 7730MOD, 7730ALS and 7730IALS. Recall # Z-1912-2009
MANUFACTURER: Vital Signs, Inc., Totowa, NJ, by letter dated June 30, 2009. Firm initiated recall is ongoing.
REASON: Not compatible: The luer connector on the Intraosseus needle provided does not fit securely on the luer connection of the IV Extension Set in the module.

PRODUCT: ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L).. Made in Switzerland. Twist drill for preparation of osteotomy during dental implant surgical drilling procedure. Recall Z-1947-2009
MANUFACTURER: Recalling Firm: BIOMET 3i LLC, Palm Beach Gardens, FL, by telephone, fax and letter, dated June 30, 2009. Manufacturer: Dentsply Maillefer, Ballaigues, Switzerland. Firm initiated recall is ongoing.
REASON: Some of the packages of ACT3020, drills may actually contain an ACT3220 drill.

PRODUCT: Celsite Access Port Model ST305P. The Celsite Access Port model ST305P is a member of the Celsite product line of implantable port and catheter systems. Recall # Z-1961-2009
MANUFACTURER: Recalling Firm: B. Braun Interventional Systems, Plymouth, MN, by letter dated June 22, 2009. Manufacturer: B.Braun Celsa Medical, Chasseneuil, France. Firm initiated recall is ongoing.
REASON: B. Braun Interventional Systems was notified by B. Braun Medical France, the manufacturer of the Celsite Access port that they had received 11 reports of polyurethane (type P) catheter disconnections. B. Braun Medical France has decided to recall all Celsite ports supplied with the affected catheter lot. To date, B. Braun Interventional Systems (US) has not received any reports of catheter disconnections. Nevertheless, B. Braun Interventional Systems (BIS) has decided to recall the above identified Celsite port systems, which were manufactured with the affected catheter lot, as a precautionary measure.

PRODUCT: iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04. Recall # Z-1965-2009
MANUFACTURER: Theken Spine LLC, Akron, OH, by telephone on August 26, 2008. Firm initiated recall is ongoing.
REASON: Failure to label the product properly. Additionally, 15 pieces were reworked and the expiration date was misprinted as 2011-04 instead of the actual date of 2010-04.

PRODUCT: 1) Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients. Recall # Z-1994-2009;2) Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients. Recall # Z-1995-2009
MANUFACTURER: Recalling Firm: GE Medical Systems Information Tecnology, Wauwatosa, WI, by letter dated February 6, 2006. Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall is ongoing.
REASON: GE Healthcare (Datex-Ohmeda) S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software had an issue where the Heart Rate (HR) was displaying as ---(3 dashes) when the monitor was used continuously for 49 days without a cold start. A missed alarm or missed HR value could cause a delay in recognition of a cardiac event that may result in a serious injury that is permanent or life threatening. There were no reported patient injuries or illnesses for the use of this device in conjunction with this device correction.

PRODUCT: Ultra-Thin LightMat Surgical Illuminator, Disposable one time use. Model Number: UA2550, Exp Date: 2012-05. Product is packaged in individual sterile pouch w/5 pouches per box. The LightMat is intended for the illumination of surgical procedures, particularly where deep cavities or adjacent tissues limit outside light in the surgical field. Recall # Z-1998-2009
MANUFACTURER: Lumitex, Inc., Strongsville, OH, by letter dated July 2, 2009. Firm initiated recall is ongoing.
REASON: Adhesive which is used to attach LightMat to retractor may not have been tested to Medical standards. The vendor provided an adhesive strip that did not conform to Lumitex specifications. The adhesive strip provided may not have met Lumitex requirements to be medical grade, EtO compatible, and biocompatible.

PRODUCT:
1) Roche Coaguchek XS System, Coaguchek XS Professional Care Kit; Catalog/Model Number 04837975001. Coaguchek XS System and Coaguchek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication. Recall # Z-2002-2009;
2) Roche Coaguchek XS System, Coaguchek XS PST Kit; Catalog/Model Number 04837738001. Coaguchek XS System and Coaguchek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication. Recall # Z-2003-2009;
3) Roche Coaguchek XS System, Coaguchek XS Plus Care Kit; Model Number 05021537001. Coaguchek XS System and Coaguchek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication. Recall # Z-2004-2009
MANUFACTURER: Recalling Firm: Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter dated July 22, 2009. Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.
REASON: The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.

PRODUCT: Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilation Catheter allows a safe and atraumatic transtracheal access for oxygenation/ventilation. Recall # Z-2010-2009
MANUFACTURER: Recalling Firm: Instrumentation Industries, Inc., Bethel Park, PA, by letter dated July 9, 2009. Manufacturer: Vbm Medizintechnik Vertriebs Gmbh, Sulz A.N., Germany. Firm initiated recall is ongoing.
REASON: User instructions not updated to correspond with product change.

PRODUCT: HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part #811905, Bottle part #1905LB. SteriChek Residual Peroxide Reagent Strips provide a convenient means of measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid. Recall # Z-2016-2009
MANUFACTURER: Hach Co., Ames, IA, by letter dated April 21, 2009 and by telephone between April 22 – 23, 2009. Firm initiated recall is complete.
REASON: Some of the reagent strip bottles contain the incorrect strips.

CLASS III
PRODUCT: Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP). In vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
Catalog Number DF34. Recall # Z-1930-2009
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter on April 15, 2008. Firm initiated recall is complete.
REASON: Falsely elevated results in EDTA plasma samples.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 11, 2009:

CLASS I
PRODUCT:
1) PRO5100, PowerPro Battery Modular Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5200, PowerPro Battery Two Trigger Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5250, PowerPro Battery Two Trigger Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5300 PowerPro Battery Oscillator Handpiece. PRO 5300 Oscillator Speed Range: 0-11,000 cpm, and PRO5400 PowerPro Battery Reciprocator Handpiece. Speed Range: 0-14,500 cpm+/- 500 cpm. Recall # Z-1950-2009;
2) PowerProMax PRO5100M Battery Single Trigger, PowerProMax PRO5200M Battery Two Trigger, PowerProMax PRO5250M Battery Two-Trigger Standard, PowerProMax PRO5300M Battery Oscillator, PowerProMax PRO5400M Battery Reciprocator, and PowerProMax PRO6200 Battery Single Trigger. Recall # Z-1951-2009;
3) Mpower PRO6200 Single Trigger Modular Handpiece, Mpower PRO6202 Battery
Two-Trigger Modular Handpiece, Mpower PRO6300 Battery Oscillating Saw, Mpower PRO6400 Battery Reciprocating Saw, and Mpower PRO6450 Battery Sternum Saw. Recall # Z-1952-2009
MANUFACTURER: Linvatec Corp. dba ConMed Linvatec, Largo, FL, by letter on July 31, 2009. Firm initiated recall is ongoing.
REASON: There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower Handpieces manufactured prior to June 1, 2008.

PRODUCT: MC5057 12ft/3.6 meters Universal Cable. Made in USA. NON STERILE Rx Only. The MC5057 Universal Cable, 12 ft, is used to connect electric handpieces to the power source. The cable is designed with a button feature that allows the user to increase or decrease the operating speed of the handpiece in use. In select handpieces, the cord button feature can select the function, i.e. screw, tap, or drill mode. Recall # Z-2007-2009
MANUFACTURER: Linvatec Corp. dba ConMed Linvatec, Largo, FL, by letter on July 31, 2009. Firm initiated recall is ongoing.
REASON: Sufficiently worn/damaged Universal Cable with product number MC5057, when used with various ConMed Linvatec electric Handpieces, may cause the handpiece to self activate.

CLASS II
PRODUCT: Whatman Body Fluid Collection Paper 903 The device is used by healthcare professionals in the collection and in-vitro storage of neonate blood. Recall # Z-1871-2009
MANUFACTURER: Whatman, Inc., Sanford, ME, by letter on May 6, 2009. Firm initiated recall is ongoing.
REASON: The two portions of the card are coming apart prematurely.

PRODUCT
BrightView Gamma Camera Radius Drive Assembly, 3/8" tilt, model number 4535604 34811, 3/4"tilt, model number 4535674 34801, and 3/8" fixed, model number 4535604 34781, all catalog number 882480 Medical device-- intended to produce images depicting anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel. Recall # Z-1892-2009
MANUFACTURER: Recalling Firm: Phillips Nuclear Medicine, Milpitas, CA, by letter on July 6, 2009. Manufacturer: Philips Medical Systems (Cleveland) Inc, Cleveland, OH. Firm initiated recall is ongoing.
REASON: Unexpected movement-- if the drive assembly is severely compromised, the detector may slide to its hardware limit.

PRODUCT: Abiomed AB5000 Portable Driver Catalog number: 0025-0000 The AB5000 System is a mechanical circulatory support system for use in patients suffering from potentially reversible ventricular dysfunction. It can also be used to facilitate patient transport. The Driver is external to the patient and is intended for short-term use. Recall # Z-1914-2009
MANUFACTURER: Abiomed, Inc., Danvers, MA, by letter on May 8, 2009. Firm initiated recall is complete.
REASON: The Emergency System Operation (ESO) mode may not provide adequate patient support under a specific operating condition

PRODUCT: Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM. General purpose aspiration Cytology Biopsy Needle. Recall # Z-1935-2009
MANUFACTURER: Remington Medical, Inc., Alpharetta, GA, by telephone on June 19, 2009 and by letter on June 30, 2009. Firm initiated recall is complete.
REASON: Two unsealed pouches were identified after product release, compromising product sterility.

PRODUCT: The BladderScan BVI 9400 is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder volume. The device consists of an ultrasound probe that scans the patient's bladder, and a battery operated console that provides measurement related information. The BVI 9400 measures ultrasonic reflections on multiple planes inside the body and produces a three dimensional image. Based on the image, the BVI 9400 calculates and displays bladder volume. Recall # Z-1939-2009;
MANUFACTURER: Verathon, Inc., Bothell, WA, by post card and telephone on or about May18, 2009. Firm initiated recall is ongoing.
REASON: Three specific issues are being addressed: 1. Calculation and use of an incorrect year in dates after 12/31/2009. 2. Double scans, continuous scans, and double printing. 3. Calibration sensitivity.

PRODUCT: Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; List Number 3D50-05. AxSYM AFP is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of alpha-fetoprotein (AFP).
Recall # Z-2222-2009
MANUFACTURER: Abbott Laboratories, Abbott Park, IL, by letters dated February 2, 2009. Firm initiated recall is ongoing.
REASON: The AxSYM Cancer Assay Disk (LN 3D50-05 version 5.0) contains an AxSYM AFP assay file where the Low Concentration flag for the AFP 1:101 automated dilution protocol the instrument to report results between 0 ng/mL and 0.4 ng/mL (40.4 ng/mL accounting for the 1:101 dilution). The sensitivity of the assay is 0.4 ng/mL.

PRODUCT: 3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, Osseotite Custom, Micromini Implant, Lot # 470258, Sterile. Custom temporary cover screws are for use in maintaining the soft tissue during the healing process of a dental restoration. Recall # Z-2227-2009
MANUFACTURER: Biomet 3i, LLC, Palm Beach Gardens, FL, by telephone and follow- up faxed letter on or about July 28, 2009. Firm initiated recall is ongoing.
REASON: Healing Abutment was not made within required manufacturing specification. The product did not have the relief behind the thread, which does not allow proper seating.

PRODUCT:
1) SKINTACT Electrodes for Defibrillation, 10X REF DF20, Rx only. The device is non-sterile and single use. For use on adults and children over eight years old for external defibrillation, pacing, monitoring, and cardioversion. Recall # Z-2233-2009;
2) S&W Electrodes for Defibrillation, 10 Defibrillation Electrodes, Reorder #90101. The device is non-sterile and single use. For use on adults and children over eight years old for external defibrillation, pacing, monitoring, and cardioversion. Recall # Z-2234-2009
MANUFACTURER: Leonhard Lang Gmbh, Innsbruck, Austria, by letter dated June 9, 2009. Firm initiated recall is ongoing.
REASON: A potential risk was identified associated with the connectors of the defibrillation electrodes DF20. It was found that some of the connectors do not slip easily into the sockets of the defibrillator or an extension cord of the defibrillator. In such cases increased force or some wiggling is required to insert the connector fully. A potential risk for patients exist, if (a) such a connector (b) is used with the nearly brandnew defibrillator or extension cord (c) in a situation imposing extensive stress on a user.

PRODUCT: ILUMAVision Software, version 2.1.0 Picture Archiving and Communication system Product used as a tool for the pre-surgical planning of the placement of dental implants and pre-surgical fabrication of stents to aid in dental implant insertion. In addition, it is used for diagnostics and treatment planning in orthodontic, ENT and similar applications. Recall # Z-2239-2009
MANUFACTURER: IMTEC IMAGING L.L.C., Ardmore, OK, by letter on August 3, 2009. Firm initiated recall is ongoing.
REASON: Under certain circumstances, software Version 2.1.0 has potential for incorrect data imaging and patient identification.

PRODUCT: 1) B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 100-48, 100 ml x 2 ml/hr Used to provide an optional filling device for the Easypump. Recall # Z-2249-2009; 2) B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hr. Recall # Z-2250-2009
MANUFACTURER: Recalling Firm: I-Flow Corp., Lake Forest, CA, by letter dated August 1, 2008. Manufacturer: B. Braun Melsungen, Melsungen, Germany. Firm initiated recall is complete.
REASON: I-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary package. Used to provide an optional filling device for the Easypump.

PRODUCT: Medtronic SynchroMed II Programmable Pump, 8637, Rx Only, Sterilized by ethylene oxide gas. (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Affected products are SynchroMed II Model 8637 pumps with batteries (MECC Lifetest Batteries) manufactured from April 9, 2002 through July 2, 2002 (internally defined as Time Period 1), and from August 15, 2003 to March 16, 2005 (internally defined as Time Period 3). The SvnchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the certain drugs and fluids. Recall # Z-2276-2009
MANUFACTURER: Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letter dated July 2009. Manufacturer: Medtronic Neuromodulation, Columbia Heights, MN. Firm initiated recall is ongoing.

REASON: This recall is related to the potential for reduced battery performance in a small percentage of Medtronic Model 8637 SynchroMed II pumps with batteries manufactured during two distinct time periods prior to April 2005. Nature of the Device Issue: As part of ongoing analysis of returned explanted product, Medtronic has confirmed that reduced battery performance resulted in eight (8) occurrences of Low Battery Reset between 47 to 56 months implant duration, and one (1) occurrence of premature Elective Replacement Indicator (ERI) at 54 months implant duration. Of the eight (8) reports of Low Battery Reset (critical alarm), seven (7) were confirmed to have occurred when a bolus was given during priming or flex programming, which places additional demand on the battery. The single report of premature ERI (non-critical alarm) occurred during simple continuous drug delivery. Analysis of these pumps showed that the alarms were functional.

PRODUCT: Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, Percutaneous Catheter, indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature. Catalog number PND6F11512M. Recall # Z-2313-2009
MANUFACTURER: Penumbra Inc., Alameda, CA, by letters on July 6, 2009 and July 7, 2009. Firm initiated recall is ongoing.
REASON: Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery'.

PRODUCT: Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile. Designed for use with femoral stems and acetabular components distributed by Smith & Nephew. Recall # Recall # Z-2314-2009
MANUFACTURER: Smith & Nephew Inc., Memphis, TN, by letter, e-mail and telephone on January 12, 2009 and by letter on April 6, 2009. Firm initiated recall is ongoing.
REASON: 46 mm Femoral head was mismarked and packaged as being 45 mm.

PRODUCT: Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. Printing results of clinical chemistry tests and test panels contained in the i-STAT test cartridges. Printer i-STAT Catalog number 06723-91; battery pack catalog number 06F21-35. Martel Printers with. Repaired printers received since November 4, 2008; Replacement chargeable battery packs received since October 30, 2008. Recall # Z-2328-2009
MANUFACTURER: Abbott Point of Care, Inc., East Windsor, NJ, by letters dated April 2009. Firm initiated recall is ongoing.
REASON: It appears that the rechargeable battery pack is overheating with or without the presence of smoke.

CLASS III
PRODUCT: Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10. In vitro diagnostic products for clinical susceptibility testing of H. influenza and Streptococcus spp. can provide both qualitative and quantitative results. Recall # Z-2324-2009
MANUFACTURER: Recalling Firm: Trek Diagnostic Systems, Cleveland, OH, by telephone on June 4, 2009. Manufacturer: Trek Diagnostics Systems Inc., Sun Prairie, WI. Firm initiated recall is ongoing.
REASON: Thirty-one boxes of unapproved quarantine product, CP112-10 MHB w/LHB, Lot # 150444SA, were inadvertently shipped to customers on 6/2/09 instead of shipping approved Lot # 150344SA.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 4, 2009:

CLASS I
PRODUCT: Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor. Automated external defibrillator deployed primarily in public access defibrillator environments where the expected use for any one device is once every 20 months. For use on persons requiring defibrillation therapy. Recall # Z-2030-2009
MANUFACTURER: Physio Control, Inc., Redmond, WA, by telephone beginning August 18, 2009and letter dated August 2009. Firm initiated recall is ongoing.
REASON: The K1 relay on the Analog printed circuit board assembly may short due to moisture ingress in a highly humid environment. K1 shorting may affect the ECG amplitude causing the Shock Advisory System (SAS) to not analyze the ECG rhythm correctly thus preventing the device from delivering therapy.

PRODUCT: Pedi-Cap CO2 Detector, 1 kg - 15 kg, Assembled in Mexico. Sold in packages of 6 (PediCap6) or 24 (PediCap). Intended for use during endotracheal or nasotracheal intubation to assist in verification of tube placement. Recall # Z-2047-2009
MANUFACTURER: Recalling Firm: Covidien Limited, Boulder, CO, by letter dated August 14, 2009. Manufacturer: Nellcor Puritan Bennett Mexico, S.A. de C.V., Tijuana B.C., Mexico. Firm initiated recall is ongoing.
REASON: CO2 detector may increase resistance to air flow in an intubated patient.

PRODUCT: Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. Intended for the introduction of interventional devices into the peripheral, coronary and neuro vasculature. Recall # Z-2049-2009
MANUFACTURER: Penumbra, Inc., Alameda, CA, by telephone and e-mail on May 29, 2009. Firm initiated recall is ongoing.
REASON: Leakage – Due to a manufacturing error, some products may have a fold in the innermost layer, causing disruption in the layering process and may result in blow holds or exposed wire braids, which may result in further damage.

PRODUCT:
1) Protex Uncuffed Paediatric Sized Tracheal Tube, Oral Nasal , Ivory 2.5 mm, Product Code: 100/105/025. Intended for oral and/or nasal intubation for airway management. Recall # Z-2056-2009;
2) Protex Uncuffed Paediatric Sized Tracheal Tube Oral Nasal, Ivory 3.0 mm, Product Code: 100/105/030. Intended for oral and/or nasal intubation for airway management. Recall # Z-2057-2009;
3) Protex Uncuffed Paediatric Sized Tracheal Tube Oral Nasal, Ivory 3.5 mm, Product Code: 100/105/035. Intended for oral and/or nasal intubation for airway management. Recall # Z-2058-2009;
4) Protex Tracheal Tube, Oral/Nasal, Siliconized, 2.5 mm Product Code: 100/111/025. Intended for oral and/or nasal intubation for airway management. Recall # Z-2059-2009;
5) Protex Tracheal Tube, Oral/Nasal, Siliconized, 3.0 mm Product Code: 100/111/030. Intended for oral and/or nasal intubation for airway management. Recall # Z-2060-2009;
6) Protex Tracheal Tube, Oral/Nasal, Siliconized, 3.5 mm Product Code: 100/111/035. Intended for oral and/or nasal intubation for airway management. Recall # Z-2061-2009;
7) Protex Tracheal Tube, Cut to Length, Oral, Siliconized, 2.5 mm Product Code: 100/126/025. Intended for oral and/or nasal intubation for airway management. Recall # Z-2062-2009;
8) Protex Tracheal Tube, Cut to Length, Oral, Siliconized, 3.0 mm Product Code: 100/126/030. Intended for oral and/or nasal intubation for airway management. Recall # Z-2063-2009;
9) Protex Tracheal Tube, Cut to Length, Oral, Siliconized, 3.5 mm Product Code: 100/126/035. Intended for oral and/or nasal intubation for airway management. Recall # Z-2064-2009;
10) Protex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 2.5 mm Product Code: 100/141/025. Intended for oral and/or nasal intubation for airway management. Recall # Z-2065-2009;
11) Protex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 3.0 mm Product Code: 100/141/030. Intended for oral and/or nasal intubation for airway management. Recall # Z-2066-2009;
12) Protex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 3.5 mm Product Code: 100/141/035. Intended for oral and/or nasal intubation for airway management. Recall # Z-2067-2009;
13) Protex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 2.5 mm Product Code: 100/127/025. Intended for oral and/or nasal intubation for airway management. Recall # Z-2068-2009;
14) Protex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 3.0 mm Product Code: 100/127/030. Intended for oral and/or nasal intubation for airway management. Recall # Z-2069-2009;
15) Protex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 3.5 mm Product Code: 100/127/035. Intended for oral and/or nasal intubation for airway management. Recall # Z-2070-2009;
16) Protex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.0 mm Product Code: 100/134/030. Intended for oral and/or nasal intubation for airway management. Recall # Z-2071-2009;
17) Protex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.5 mm Product Code: 100/134/035. Intended for oral and/or nasal intubation for airway management. Recall # Z-2072-2009
MANUFACTURER: Smiths Medical, Hythe Kent, United Kingdom, by letter dated August 24, 2009 and September 9, 2009. Firm initiated recall is ongoing.
REASON: Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway.

CLASS II
PRODUCT: CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System. Indicated for treatment for planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall # Z-1810-2009
MANUFACTURER: Accuray Inc., Sunnyvale, CA, by letter dated June 22, 2009. Firm initiated recall is ongoing.
REASON: Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area.

PRODUCT: EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test Strip x 10 ct.; Normal Control Solution; Carrying Case; Alkaline Battery x 2 ct.; Lancets x 5 ct.; Lancing Device; AST Lancing Device Cap; User's Manual; Test Strip Instructions and Control Solution Instructions. Indicated for use at home by persons with diabetes or in clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control. Recall # Recall # Z-1937-2009
MANUFACTURER: Recalling Firm: Oak Tree International Holdings, LLC, Inc., Elyria, OH, by letter dated May 26, 2009. Manufacturer: EPS Bio Technology Corp., Hsinchu City, Taiwan. Firm initiated recall is ongoing.
REASON: Blood glucose meters, which were set to the mmol/L. unit of measure, rather than the accepted/labeled mg./dL unit of measure, were distributed.

PRODUCT: Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil Part #Q7000021. The indications for use are routine MR imaging. Recall # Z-1938-2009
MANUFACTURER: Quality Electrodynamics Llc, Cleveland, OH, by e-mail beginning December 29, 2008. Firm initiated recall is ongoing.
REASON: The firm received a complaint indicating that the mirror is high risk and could drop on a patient.

PRODUCT:
1) Hudson RICA Sher-I-Swiv & Sher-I-Swiv F/O, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. a) Catalog Number: 5-15301; and b) Catalog Number: 5-15401. Recall # Z-1940-2009;
2) Hudson RICA Sheridan, ET Tube, Sher-I-Bronch LS, 28FR, 35FR, 37FR, 39FR and 41FR. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. a) Catalog Number: 5-16028; b) Catalog Number: 5-16035; c) Catalog Number: 5-16037; d) Catalog Number: 5-16039; and e) Catalog Number: 5-16041. Recall # Z-1941-2009;
3) Hudson RICA Sheridan, ET Tube, Sher-I-Bronch RS, 28FR, 35 FR, 37 FR, 39FR and 41 FR. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. a) Catalog Number: 5-16128; b) Catalog Number: 5-16135; c) Catalog Number: 5-16137; d) Catalog Number: 5-16139; and e) Catalog Number: 5-16141. Recall # Z-1942-2009;
4) Hudson RICA Sheridan, Sher-I-Bronch Accessory Pack. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. Catalog Number: 5-16142. Recall # Z-1943-2009;
5) Hudson RICA Sheridan, EB Tube, Sher-I-Bronch, LS, 35FR, Nova Plus, 37FR, 39 FR, and 41 FR. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. a) Catalog Number: V5-16035; b) Catalog Number: V5-16037, c) Catalog Number: V5-16039; and d) Catalog Number: V5-16041. Recall # Z-1944-2009
MANUFACTURER: Recalling Firm: Teleflex Medical, Durham, NC, by letters starting July 31, 2009. Manufacturer: Teleflex Medical, Inc., Tecate, B.C., Mexico. Firm initiated recall is ongoing.
REASON: The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs.

PRODUCT: BD Diagnostics GeneOhm (BDDG) has determined that the Cepheid SmartCycler reaction tubes packaged in the BD GeneOhm MRSA test kits identified above may be defective. a) Catalog Number: 441242; and b) Catalog Number: 441244. Recall # Z-1963-2009
MANUFACTURER: Recalling Firm: BD Diagnostics, GeneOhm Sciences, Inc., San Diego, CA, by telephone on November 17, 2008 followed by a letter dated November 21, 2008. Manufacturer: Bd Diagnostics Geneohm, Quebec, Canada. Firm initiated recall is ongoing.
REASON: BD Diagnostics GeneOhm (BDDG) has determined that the Cepheid SmartCycler reaction tubes packaged in the BD GeneOhm MRSA test kits identified above may be defective.

PRODUCT: 1) Roche/Hitachi Preciset TDM I; Catalog No. 03375790 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma. Recall # Z-2000-2009; 2) Roche/Hitachi Preciset TDM II; Catalog No. 03375781 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma. Recall # Z-2001-2009
MANUFACTURER: Roche Diagnostics, Corp., Indianapolis, IN, by letter dated April 22, 2009. Firm initiated recall is ongoing.
REASON: The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles.

PRODUCT:
1) Roche ACCU-CHEK Performa blood glucose test strips, Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood. REF Numbers: 4861680020, 4861680023, 4861680031, 4861680039, 4861680053, 4861680136, 4862414003, 4862414016, 4862414020, 4862414023, 4862414031, 4862414039, 4862414053, 4862414136, 4862414170, 4948858020, 4948858039, 4948874031 and 5235243001. Recall # Z-2005-2009;
2) Roche ACCU-CHEK Performa blood glucose meters/kits. Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood. REF Numbers: 4861574019, 4861574020, 4861582014, 4861582019, 4861582020, 4861582034, 4862015023, 4862015027 and 4929381023. Recall # Z-2006-2009
MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letter dated June 10, 2009. Firm initiated recall is ongoing.
REASON: There may be a significant negative bias when testing neonate samples.

PRODUCT: Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator, Oxygen, Molecular Sieve, S/A, P/N: 70309-03900-101, Mfg P/N 3261165-0101. Z-2009-2009
MANUFACTURER: Carleton Life Support Systems Inc., Davenport, IA, by letters dated July 24, 2009 and July 28, 2009. Firm initiated recall is ongoing.
REASON: The backup oxygen supply control valve on the oxygen concentrator could fail resulting in it sticking in the open or closed positions.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 28, 2009:

CLASS II
PRODUCT: ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT Therapist Assist system (Part Number 8162807), with Software version NET VA10A for RTT4.1.122 or RTT 4.1.125. Medical charged-particle radiation therapy system. Recall # Z-1888-2009
MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on April 9, 2009. Firm initiated recall is ongoing.
REASON: Unexpected treatment plan alteration—Software issue may result in unintended modifications to treatment.

PRODUCT: EasyLink Informatics System included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Part Number: 1000046623. Recall # Z-1991-2009
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated July 2009. Firm initiated recall is ongoing.
REASON: Incorrect results may be transmitted to LIS.

PRODUCT:
1) Posey Key Lock Belt Catalog # 1334. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2254-2009;
2) Posey Fifth Point Restraint, Locking Catalog # 2219L. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2255-2009;
3) Posey Connecting Strap/Belt, Cotton, 36" Catalog #232036. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2256-2009;
4) Posey Connecting Strap/Belt, Cotton, 48" Catalog # 232048. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2257-2009;
5) Posey Connecting Strap/Belt, Cotton, 60" Catalog # 232060. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2258-2009;
6) Posey Connecting Strap/Belt, Cotton, 72" Catalog # 232072. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2259-2009;
7) Posey Connecting Strap/Belt, Polypropylene, 18" Catalog # 235018. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2260-2009;
8) Posey Connecting Strap/Belt, Polypropylene, 24" Catalog # 235024. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2261-2009;
9) Posey Connecting Strap/Belt, Polypropylene, 36" Catalog # 235036. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2262-2009;
10) Posey Connecting Strap/Belt, Polypropylene, 48" Catalog # 235048. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2263-2009;
11) Posey Connecting Strap/Belt, Polypropylene, 60" Catalog # 235060. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2264-2009;
12) Posey Connecting Strap/Belt, Polypropylene, 72" Catalog # 235072. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2265-2009;
13) Posey Locking Twice-As Tough Cuffs, Wrists (lock on strap) Catalog # 2792. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2266-2009;
14) Posey Locking Twice-As Tough Cuffs, Ankles (lock on strap) Catalog # 2793. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2267-2009;
15) Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed), Catalog # 2794. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2268-2009;
16) Posey Connected Twice-As Tough Cuffs, Ankles (for use on bed) Catalog # 2795. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2269-2009;
17) Posey Locking Twice-As Tough Cuffs, Wrists (lock on cuff & strap) (2798). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2270-2009;
18) Posey Locking Twice-As Tough Cuffs, Ankles (lock on cuff and strap), Catalog # 2799. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2271-2009;
19) Posey Locking Twice-As Tough Ambulatory Belt, Catalog # 2800. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2272-2009;
20) Special Order, Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed) Catalog # S27947. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall #: Z-2273-2009;
21) Special Order, Posey Connected Twice-As-Tough Cuffs, Ankle (for use on the bed) , Catalog # S27957. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2274-2009;
22) Posey Swedish Belt, Catalog #1337. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2275-2009
MANUFACTURER: J. T. Posey, Co., Arcadia, CA, by letter dated May 14, 2009. Firm initiated recall is ongoing.
REASON: Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.

PRODUCT: Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software. The software delivers a scalable and flexible DICOM storage solution for Cardiology and Radiology images. Recall # Z-2316-2009
MANUFACTURER: GE Healthcare Integrated IT Solution, Barrington, IL, by letters dated August 7, 2009. Firm initiated recall is ongoing.
REASON: Software error: There is potential safety issue with Centricity Enterprise Archive (EA) 3.0.x software where study split operations are not correctly replicated to a secondary 'shadow' archive.

PRODUCT: 1) DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30. In-vitro diagnostic device used for the quantitative measurement of creatine in serum, plasma and urine. Recall # Z-2326-2009;
2) DCL (Diagnostic Chemicals Limited) Creatine Start Reagent (R1) Catalog Number: 265-OP. Recall # Z-2327-2009
MANUFACTURER: Diagnostic Chemicals, Ltd., Charlottetown Prince Edward Island, Canada, by letter dated February 12, 2009. Firm initiated recall is ongoing.
REASON: Labeled with extended expiration date (24 months instead of 18 months)

CLASS III
PRODUCT: Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300. The Balanced Knee System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral stability. Recall # Z-1993-2009
MANUFACTURER: Ortho Development Corp., Draper, UT, by e-mail on May 29, 3009 and June 5, 2009. Firm initiated recall is ongoing.
REASON: Erroneous lot number on 3 of 28 units of Balanced Knee System. Three units from Lot Number 0055245 were mixed in with the recalled Lot Number 0054891.

PRODUCT: 300 Microliter CO-RE Tips for use with Microlab STAR. Product is a disposable product used with Microlab STAR series Instruments, which are microtiter diluting and dispensing devices. Part Number 235950 (case containing 11,520 tips), and Part Number 235902 (case containing 5,760 tips). Recall # Z-1999-2009
MANUFACTURER: Hamilton, Co., Reno, NV, by letter and e-mail on April 10, 2009. Firm initiated recall is ongoing.
REASON: Product Defect-- some tips from the mold cavity 28 are too short and do not always aspirate or dispense liquid correctly.

PRODUCT: Acuvue Advance for Astigmatism Diagnostic Product. Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl. 180 Axis Exp. 2014/07. Actual Primary Package Label: Lot B007NV5 7.50D 1.75cyl. 20 Axis Exp. 2014/12. Product was provided to Eye Care professionals to use as diagnostic replenishment. Product used by Eye Care professionals in the fitting process. Recall # Z-2012-2009
MANUFACTURER: Vistakon, Jacksonville, FL, by telephone from April 7, 2009 to April 27, 2009. Firm initiated recall is complete.
REASON: Vistakon is recalling Acuvue Advance for Astigmatism Diagnostic product for mislabeling.

PRODUCT: AxSYM System Tubing Decontamination Solution; 500 mL bottle; List Number 07B05-09. To be used only for cleaning and inhibition of fouling bacteria in the tubing system of the in vitro immunoassay analyzer. This product does not disinfect or sterilize the tubing system. Recall # Z-2317-2009
MANUFACTURER: Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letters dated February 18, 2009. Manufacturer: Minntech Corp., Plymouth, MN. Firm initiated recall is ongoing.
REASON: Bottle labels from lot 211974, AxSYM System Tubing Decontamination Solution (List Number 7B05-09), were found to be missing the following information: lot number, date of manufacture, and expiration date.

PRODUCT: ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-ROM - WW (excluding US), list 6E59-23, Version 23.0, containing the ARCHITECT LH assay file; Product List Number: 6E58 (US) and 6E59 (WW) Versions 23 and lower. The Architect LH assay is a Chemiluminescent Microparticle Immunoassay for the quantitative determination of human luteinizing hormone (LH) in human serum or plasma. Recall # Z-2325-2009
MANUFACTURER: Abbott Laboratories, Abbott Park, IL, by letter dated April 24, 2009. Firm initiated recall is ongoing.
REASON: There continues to be an elevated level of complaint activity for calibration error code 1227, when using ARCHITECT LH reagent lots (6C25-22 or 6C25-27) due to the use of assay disk versions that do not contain the updated ARCHITECT LH assay file contained on ARCHITECT i System Assay CD ROM versions 24 and higher (US LN 6E58, WW LN 6E59).

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of October 21, 2009:

CLASS II
PRODUCT: Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 02. The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx 01 with N-DISVENT 02, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is intended for use by qualified medical personnel only. Recall # Z-1558-2009
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter on or about April 9, 2009. Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall is ongoing.
REASON: GE Healthcare has recently become aware of an issue in the calculations associated with Datex-Ohmeda S/5 Device Interfacing Solution N-DISVENT-02 interfaced between certain Datex-Ohmeda patient monitors (Datex-Ohmeda S/5 Anesthesia Monitor (AM), Datex-Ohmeda S/5 Critical Care Monitor (CCM), Datex-Ohmeda S/5 Compact Anesthesia Monitor (CAM), Datex-Ohmeda S/5 Compact Critical Care Monitor (CCCM)) and the Datex-Ohmeda Anesthesia Machine or Ventilator Advance, Aisys or Engstrom Carestation.

PRODUCT: GE Healthcare CIC Pro Clinical Information Center Central Station (CIC Pro version 5.1, MP100 Hardware). The CIC Pro" clinical Information Center central station is intended to collect information from a network and display this date. This data includes physiological, patient dermographic and/or other non-medical information. Recall # Z-1600-2009
MANUFACTURER: Recalling Firm: GE Medical Systems Information Technology, Wauwatosa, WI, by letter dated February 24, 2009. Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.
REASON: GE Healthcare has become aware of a potential issue associated with the failure to restart CARESCAPE CIC Pro v5.1 on the MP100 hardware. This issue may impact patient safety.

PRODUCT: Clinac with Version 7.x Software. Model Numbers: H14, H27 and H29. Part of the Trilogy Radiotherapy Delivery System for radiation therapy intended to delivery megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy. Recall # Z-1729-2009
MANUFACTURER: Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter dated May 29, 2009. Firm initiated recall is ongoing.
REASON: Unexpected Movement: if the stereotactic motion disable function is turned on, the couch can be moved via float mode unexpectedly.

PRODUCT: Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, The Varis RV function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan. Additional applications provide various data management and library functions. Recall # Z-1809-2009
MANUFACTURER: Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter dated May 8, 2009. Firm initiated recall is ongoing.
REASON: Potential mistreatment-- due to software issues, retired plans may be used and treated repeatedly.

PRODUCT: Pyxis Anesthesia System 3500, The Pyxis Anesthesia Station 3500 is a medication dispensing product that provides medication and inventory management for the anesthesiologist at the point of care within the operating room. The system tracks and stores controlled substances, medications and supplies for anesthesia providers and automates verification of patient usage records, documents waste, manages inventory levels and tracks utilization. Recall # Z-1883-2009
MANUFACTURER: Cardinal Health Manufacturing, LLC, San Diego, CA, by letter on December 17, 2008. Firm initiated recall is ongoing.
REASON: Cardinal Health has sent out a Safety Alert Notification to inform its customers that the SR2b Software for the Pyxis Anesthesia System 3500 (PAS 3500) has received several customer reports of system "non-responsiveness" (lock ups) during the use of the product since its release in September 2008.

PRODUCT: Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM Not Sterile: Catalog number 48906075. The Trio 3.5MM Hex Socket is a reusable instrument, sterilized prior to use, used with the Trio Torque Wrench to facilitate final tightening of Trio connectors and 3.5MM Hex Screw Assembly. This Trio 3.5MM Hex Socket is used with the Trio implant system for posterior noncervical pedical and non pedical fixation of the spine. Recall # Z-1886-2009
MANUFACTURER: Recalling Firm: Stryker Spine, Allendale, NJ, by letters on July 1, 2009. Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is ongoing.
REASON: The Trio 3.5MM Hex socket has been reported to break under high stresses.

PRODUCT: Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion. a) Model Number: 1350BF85, b) Model Number: 1351BF7, c) Model Number: 1351BF85H, d) Model Number: 1450BF85, e) Model Number: 1451BF6, f) Model Number: 1451BF8, g) Model Number: 1452BF85H, h) Model Number: 1550BF6C, i) Model Number: 1550BF7C, j) Model Number: 1550BF8, k) Model Number: 1550BF85, l) Model Number: 1551BF85H, m) Model Number: 1650BF85, n) Model Number: 1651BF85, o) Model Number: 1652BF85H, p) Model Number: S310740C, and q) Model Number: S5507BF85. Recall # Z-1913-2009
MANUFACTURER: Recalling Firm: Edwards Lifesciences, LLC, Irvine, CA, by letters dated May 11, 2009. Manufacturer: Edwards Lifesciences Technology SARL, Anasco, PR. Firm initiated recall is ongoing.
REASON: Edwards LifeSciences LLC received several complaints, in which the blue connector of the introducer assembly has broken (fracture/separation) after several hours of use.

PRODUCT: AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS AmpliPrep/COBAS TaqMan is capable of tuning HBV, HCV, and HIV tests. Recall # Z-1928-2009
MANUFACTURER: Recalling Firm: Roche Molecular Systems, Inc., Somerville, NJ, by letters on June 2, 2009. Manufacturer: Roche Instrument Center AG, Rotkreuz, Switzerland. Firm initiated recall is ongoing.
REASON: Software bug: A unique series of events involving the COBAS AmpliPrep instrument running AMPLILINK software version 3.2.2 that results in specimens being amplified and detected with the wrong parameters. The error can occur on either COBAS AmpliPrep/COBAS TaqMan 48, COBAS AmpliPrep/COBAS TaqMan (docked) or cobas s 201 system (docked) running Amplilink Software versions 3.1 or 3.2 series up to and including 3.2.2.

PRODUCT: FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with FreeStyle Lite Blood Glucose Meters and FreeStyle Freedom Lite Blood Glucose Meters, Part Number 70822-02. The product is used for testing outside the body (in vitro) diagnostic use, in the home and in professional settings to monitor blood glucose levels. Recall # Z-1936-2009
MANUFACTURER: Abbott Diabetes Care, Inc., Alameda, CA, by letter dated June 10, 2009. Firm initiated recall is ongoing
REASON: Low results: Freestyle Lite Blood Glucose Test strip may generate low blood glucose readings when tested with the control solution from lot 0822524 with Freestyle Freedom Lite and Freestyle Lite Blood Glucose Meters.

PRODUCT: Maxilift Patient Lift, Non-AC Powered; a patient lift with a four point tilting frame, adjustable chassis, and optional electronic scale, to move patients in a hospital/nursing home situation; Model numbers 21102406, 21200001, 21200006, 21000-01, 210024-06, 211010-06, 211024-06, 211026, 212000-06, 212000-06R, 212000-6, 212024-06, 212026, 212624, 218100-01, KGA0200, KMA0520, KMA1003-04, KMA1004, KMA1005, KMA1006, KMA1040, KMA1501-06, KMA1513-06, KMA211024, KMA82124-24, KMB2351, KMB4800-06, KMB4900-06, KMB5501-12US, KRA0300, KRA0310, KRA1000, KRA1500-12, KRA2100, KRA3000-12, MA0500, MA0510, MA1010, MA1020, MA1100, MA1500, Maxi Pillar, Maxilift, Maxipillar, MAXIPILLER, MB0500R, MB0510, and MB0610. The patient lift is intended to move and transport patients/residents under the direct supervision of trained staff. Recall # Z-1945-2009
MANUFACTURER: Recalling Firm: ArjoHuntleigh, Addison, IL, by letter on April 27, 2009. Manufacturer: Arjo Med. AB, Gloucester, United Kingdom. Firm initiated recall is ongoing.
REASON: The roll pin on certain configurations of the Maxilift hanger bar could break due to a combination of severe corrosion and fatigue. Breakage of the roll pin would lead to the detachment of the hanger bar from the jib of the lifter.

PRODUCT: BARD Simpulse" SOLO System with Soft Splash Shield Tip Product Code: 0067590. The Simpulse SOLO Suction/Irrigator is designed to provide controlled powered irrigation during open orthopedic and general surgical procedures and for the cleansing of burns or wounds. Appropriate fluids for use include fluids with specific gravity less than 1. The pulsatile action of the pump helps to remove blood, tissue debris and foreign matter from the operative or wound site. When connected to a suction source, the device can be used to aspirate fluids from the operative or wound site. Recall # Z-1948-2009
MANUFACTURER: Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Warwick, RI, by letter dated July 30, 2009. Manufacturer: Davol Surgical Innovations S.A. de C.V., Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON: Product sterility may be compromised due to lack of package integrity.

PRODUCT: MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant. The product is used as a endosseous dental implant. a) product code MII-OB13; b) product code MII-OB15. Recall # Z-1997-2009
MANUFACTURER: IMTEC Corp., Ardmore, OK, by letter dated July 7, 2009. Firm initiated recall is ongoing.
REASON: Size printed on product packaging does not match size of enclosed product.

PRODUCT:
1) Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F, NON STERILE, REF 000256. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support. Recall # Z-2017-2009;
2) Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.2cm, NON STERILE, REF 000292. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support. Recall # Z-2018-2009;
3) Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000282. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support. Recall # Z-2019-2009;
4) Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 2.4cm, NON STERILE, REF 000283. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support. Recall # Z-2020-2009;
5) Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000284. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support. Recall # Z-2021-2009
MANUFACTURER: C R Bard Inc., Salt Lake City, UT, by letter January 20, 2009. Firm initiated recall is ongoing.
REASON: Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.

PRODUCT: Integra NeuroSciences a) Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and b) Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit with Ventricular Drainage System NL950-VC. This intracranial pressure (ICP) catheter is indicated for use on patients that require continuous invasive intracranial pressure monitoring and/or cerebrospinal drainage. Access is achieved through a tunneled technique using the included trocar. Recall # Z-2053-2009
MANUFACTURER: Integra Neuro Sciences, San Diego, CA, letter dated March 23, 2009. Firm initiated recall is ongoing.
REASON: Due to a dimensional error, the diameter of the stylet provided with the device may be too large to insert into the lumen of the catheter tip.

PRODUCT:
1) Nerve Block Tray, Disposable, Convenience Kit, Reorder Number DYNJTS0382B. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2079-2009;
2) Universal Block Tray, Disposable, Convenience Tray, Reorder Number CUS1407-06. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2080-2009;
3) Nerve Block Tray, Disposable, Convenience Kit, Reorder Number CUS1234. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2081-2009;
4) Single Shot Epidural Tray, Disposable Convenience Kit, Reorder Number CUS1474-01. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2082-2009;
5) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number 10-2378. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2083-2009;
6) Hand Drill - Sterile, Disposable, Convenience Kit, Reorder Number INS030. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2084-2009;
7) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS511-08. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2085-2009;
8) Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1736-02. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2086-2009;
9) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1729-01. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2087-2009;
10) Block Tray, Disposable, Convenience Kit, Reorder Number CUS835. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2088-2009;
11) Biopsy Tray (BMTX-1039), Disposable, Convenience Kit, Reorder Number CUS1189. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2089-2009;
12) Nerve Block Tray, Disposable, Convenience Kit, Reorder Number CUS1044-02. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2090-2009;
13) Tuohy Needle, 20G X 3.5", Removable Wing, Plastic Hub, Metal Stylet, Calibrations (10BX), Disposable, Convenience Kit, Reorder Number PITRW2035. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2091-2009;
14) Custom Procedure Tray, Disposable, Convenience Kit, Reorder Number CUS015-01. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2092-2009;
15) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1453. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2093-2009;
16) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1427. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2094-2009;
17) Nerve Block Tray, Disposable, Convenience Kit, Reorder Number 10-2527. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2095-2009;
18) Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS651. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2096-2009;
19) Extension Set Pack, Disposable, Convenience Kit, Reorder Number CUS994. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2097-2009;
20) CHIBA Spinal 22G X 3.50, Plastic Hub, Metal Stylet, Disposable, Convenience Kit, Reorder Number PICH2235. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2098-2009;
21) Epidural Catheter Pack with Stylet, Disposable, Convenience Kit, Reorder Number CA20CES. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2099-2009;
22) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1722-01. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2100-2009;
23) Universal Painpak, Disposable, Convenience Kit, Reorder Number SS3278. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2101-2009;
24) South Texas Pain Tray, Disposable, Convenience Kit, Reorder Number CUS1308-01. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2102-2009;
25) Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1619. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2103-2009;
26) Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1756. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2104-2009;
27) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1593-01. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2105-2009;
28) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1719. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2106-2009;
29) Complete Single Shot Tray, Disposable, Convenience Kit, Reorder Number CUS042. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2107-2009;
30) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS185-01. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2108-2009
MANUFACTURER: Integra Life Sciences Corp., Salt Lake City, UT, by telephone on July 09, 2009 and letter on July 13, 2009. Firm initiated recall is ongoing.
REASON: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.

PRODUCT:
Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated monitor with an external portable defibrillator used by healthcare providers in EMS, hospital and clinic settings. It operates in a manual or semi-automatic defibrillation mode and is offered with optional monitoring functions including Non-Invasive Blood Pressure (NIBP). When clinically indicated the LIFEPAK 15 allows the operator to deliver a brief, high energy, external shock through the chest to a patient's heart. Recall # Z-2110-2009
MANUFACTURER: Physio Control, Inc., Redmond, WA, by letter dated August 2009. Firm initiated recall is ongoing.
REASON: Some LIFEPAK 15 Monitor/Defibrillators have a Non-Invasive Blood Pressure (NIBP) module that was supplied by CAS Medical Systems, who is recalling the modules. The NIBP modules may be susceptible to sudden changes in cuff pressure. Sudden changes in cuff pressure may possibly be caused by bumping or squeezing the cuff. In some instances this may result in a screen display reading of "XXX" instead of a valid NlBP reading. If this happens, the NlBP function will be disabled until the device power is cycled off and back on. This issue does not impact delivery of defibrillation therapy or any other functions of the LIFEPAK 15 monitor/defibrillator.

PRODUCT: Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system. Recall # Z-2231-2009
MANUFACTURER: Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on July 17, 2009. Firm initiated recall is ongoing.
REASON: Software Issue/Mistreatment Potential -- Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered.

PRODUCT: Oridion Medical Capnostream20 capnograph pulse oximeter monitor and monitor with printer. Part Number Part Description CS08651, Capnostream20 with Nellcor pulse oximetry module CS08653 Capnostream20 with Masimo pulse oximetry module CS08657 Capnostream20 with Nellcor pulse oximetry module and printer CS08659 Capnostream20 with Masimo pulse oximetry module and printer. Recall # Z-2232-2009
MANUFACTURER: Oridion Medical 1987 Ltd., Jerusalem, Israel, by letter on June 25, 2009. Firm initiated recall is ongoing.
REASON: 1) The monitor’s ability to withstand electrostatic discharge (ESD) to exposed metal connectors on the back of the monitor which may cause the monitor’s display to freeze. 2) The unit generates electromagnetic radiation above the limits set by applicable standards for medical devices.

PRODUCT:
1) Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation therapy. Recall # Z-2236-2009;
2) Action Products, Inc., Bol-X-II, 30x30x1.0cm, item number 32102, packaged 10/carton. Polymer pad used during radiation therapy. Recall # Z-2237-2009
MANUFACTURER: Action Products, Inc., Hagerstown, MD, by telephone and e-mail on June 26, 2009. Firm initiated recall is complete.
REASON: Medical device intended for use by healthcare practitioners was incorrectly labeled. 1.0 cm thick pad was labeled as 0.5 cm thickness, and vice versa.

PRODUCT: SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used in conjunction with SUNCHRON LX System(s), UniCel DxC 600/800 Systems(s), SYNCHRON CX Systems(s) and SYNCHRON Systems Salicylate Calibrator, is intended for the quantitative determination of Salicylate concentration in human serum of plasma. Recall # Z-2238-2009
MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter dated October 22, 2007. Manufacturer: Beckman Coulter, Inc., Carlsbad, CA. Firm initiated recall is ongoing.
REASON: The Salicylate Reagent lots listed here may fail calibration and/or fail to maintain linearity at the upper end of analytical range.

PRODUCT:
1) GE, Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. Recall # Z-2240-2009;
2) Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System. (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Recall # Z-2241-2009;
3) Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Recall # Z-2242-2009
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated June 25, 2009. Manufacturer: GE Medical Systems SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON: GE Healthcare has recently become aware of a potential power supply failure with the Innova 2000, 3100 and 4100 systems that may impact patient safety. A potential power supply failure inside the GE equipment cabinet could occur with no advance warning and thereby prevent x-ray generation and image processing. Should this occur, the system cannot be restarted.

PRODUCT: TomoTherapy Hi-Art System, Version 3.X . The TomoTherapy HI-ART System® is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. Recall # Z-2243-2009
MANUFACTURER: TomoTherapy Incorporated, Madison, WI, by letter dated August 10, 2009. Firm initiated recall is ongoing.
REASON: TomoTherapy received one customer report indicating that after starting a patient procedure from the Status Console, the radiation on light and the audible indicator on the Status Console came on as expected, however the Operator Station (OS) did not display the dose rate and the procedure time, or the couch position updates. Within a few minutes, the customer pressed the Stop button on the Status Console and the radiation indicators on the Status Console shut off. After rebooting the system, the procedure that had just been attempted was marked scheduled, indicating it had not yet been initiated. This issue affects all TomoTherapy Hi-Art systems.

PRODUCT:
1) AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7001-21, packaged 10 syringes per package, 10 packages per carton. Recall # Z-2247-2009;
2) AccuSure, U-100, 31Gauge, 1cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7002-21, packaged 10 syringes per package, 10 packages per carton . Recall # Z-2248-2009
MANUFACTURER: Recalling Firm: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, by press release and letter on August 21, 2009.
Manufacturer: Hosuk Co. Ltd., Chungbuk, Republic Of (South) Korea. Firm initiated recall is ongoing.
REASON: Needles separate from the barrels of the syringes.

PRODUCT: BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 - Radiosurgery 3.0 Catalog number 20620 - Radiosurgery 3.5 and Catalog number 20630 - Circular ARC SRS/SRT Planning. The software is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and extracranial lesions. It is intended to be used by experienced and trained health professionals. Recall # Z-2251-2009
MANUFACTURER: Brainlab AG, Muenchen, Germany, by letter dated August 12, 2009. Firm initiated recall is ongoing.
REASON: Failure to conduct important safety checks when using the BrainLab radiotherapy treatment planning software in combination with BrainLab conical collimators could result in unintended radiation outside the conical shaped field, which may lead to serious injury of the patient.

PRODUCT: Flexiflo Quantum Enteral Pump Model # 50596, 50598 and 59322. The Flexiflo Quantum enteral pump is a medical device that is used to deliver enteral nutrition products to tube-fed patients. The pumps are generally used in hospitals, nursing homes, health care institutions and home care. Recall # Z-2252-2009
MANUFACTURER: Recalling Firm: Abbott Nutrition, Abbott Laboratories, Columbus, OH, by letter dated September 4, 2009. Manufacturer: Hospira Inc., Morgan Hill, CA, Firm initiated recall is ongoing.
REASON: The firm initiated this voluntary recall because some of its Flexiflo Quantum Enteral Pumps have a 110-volt AC power cord plug that may crack or fail. This potential power cord plug failure may cause electrical shock and/or a delay in feeding that could represent a potential health and safety risk.

PRODUCT: VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing. Recall # Z-2253-2009
MANUFACTURER: Neuro Kinetics, Pittsburgh, PA, by letter on August 10, 2009. Firm initiated recall is ongoing.
REASON: Marketed without a 510k or PMA submission to include the normative data display.

CLASS III
PRODUCT: ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm) Rx only, Latex Free; Sterile Health Industry Bar Code: H984BWS4464509A. Packaged in boxes of 15 units per box. Product Order # 44650. Recall # Z-1814-2009
MANUFACTURER: Recalling Firm: ConvaTec, Skillman, NJ, by letters on July 13, 2009. Manufacturer: Boehringer Wound Systems LLC, Norristown, PA. Firm initiated recall is ongoing.
REASON: Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of October 14, 2009:

CLASS I
PRODUCT:
1) Medtronic Indura 1P Intrathecal Catheter, model 8709SC, Method of Sterilization: Ethylene Oxide. The implanted infusion system components consist of a Medtronic pump and a model 8709SC Catheter. The catheter connects to the pump at the catheter port. Contents: 81.4-cm Catheter with length markers and guide wire, 15 T-guage introducer needle, Sutureless pump connector with attached 7.6-cm catheter and connector pin, Transparent strain-relief sleeves, Anchors. This is a component of an implantable drug infusion system, which consists of a drug infusion pump and a catheter. The drug infusion system stores and delivers parenteral drugs to the intrathecal space. Recall # Z-2073-2009;
2) Medtronic Intrathecal Catheter, model 8731SC, Method of Sterilization: Ethylene Oxide. The 8731SC catheter is a two-piece catheter with a thin-walled spinal segment and a thicker-walled pump segment. These segments connect to each other with a connector pin. The pump segment connects to the pump with a sutureless pump connector. Contents: 38.1-cm spinal segment with length markings and guide wire 66-cm pump segment, separate connector pin, 15 T-guage introducer needles, Transparent strain-relief sleeves, opaque strain-relief sleeves, V-wing anchors. This is a component of an implantable drug infusion system, which consists of a drug infusion pump and a catheter. The drug infusion system stores and delivers parenteral drugs to the intrathecal space. Recall # Z-2074-2009;
3) Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC, Method of Sterilization: Ethylene Oxide. Contents: 66-cm-pump segment with attached sutureless pump connector, Spinal segment strain-relief sleeves, Pump Segment strain-relief sleeves, connector pin. This is a component of an implantable drug infusion system, which consists of a drug infusion pump and a catheter. The drug infusion system stores and delivers parenteral drugs to the intrathecal space. Recall # Z-2075-2009;
4) Medtronic Sutureless Pump Connector Revision Kit, model 8578, Method of Sterilization: Ethylene Oxide. The 8578 revision kit catheter connects to the catheter interface with a connector pin and strain-relief sleeve. The catheter interface connects to the pump with a sutureless pump connector. The 8578 revision kit is for use with 8709 and 8709SC catheters. Contents: Catheter interface with attached sutureless pump connector, catheter, connector pin and strain-relief sleeve. This is a component of an implantable drug infusion system, which consists of a drug infusion pump and a catheter. The drug infusion system stores and delivers parenteral drugs to the intrathecal space. Recall # Z-2076-2009
MANUFACTURER: Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letter on August 14, 2009. Manufacturer: Medtronic Neuromodulation, Columbia Heights, MN. Firm initiated recall is ongoing.
REASON: Current labeling for Medtronic Sutureless Connector (SC) catheters and revision kits (hereafter referred to as SC catheters) incorrectly states that SC catheters are compatible with Medtronic IsoMed constant-flow infusion pumps. SC catheters are compatible with Medtronic SynchroMed II and SynchroMed EL pumps. Medtronic has determined that SC catheters are not compatible with IsoMed pumps. A physical interference between the SC catheter connector and the IsoMed pump prevents the SC catheter from completely connecting to the IsoMed pump even though it may appear to be connected and feel secure. This incompatibility is a design issue and is not related to implant technique. Incomplete connection may result in catheter disconnection from the IsoMed pump or an occlusion at the connection site which could lead to drug underdose, drug withdrawal or other clinically significant manifestations. Connection of an SC catheter to an IsoMed pump does not damage the IsoMed pump.

CLASS II
PRODUCT:
Sybaritic, NannoLight MP50. Model Numbers and Description: 1.) 304207-MP 220 Volt, Multi-Platform configuration (able to attach optional laser handpiece when purchased separately), Subassembly (unit only, no safety glasses, owner's manual, etc. included); 2.) 404207 Completed unit (safety glasses, owner's manual, etc. included), glossy finish, 220 Volt; 3.) 404207-MP Completed unit, matte finish, 220 Volt, Multi-Platform configuration; 4.) 404207-B Completed unit, matte finish, 220 Volt; 5.) 404207-USAB Completed unit, matte finish, 220 Volt, USA-style power cord; 6.) 404208-B Completed unit, matte finish, 110 Volt; and 7.) 404208-MP Completed unit, matte finish, 110 Volt, Multi-Platform configuration. The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. Recall # Z-1444-2009
MANUFACTURER: Recalling Firm: Sybaritic, Inc., Bloomington, MN, by letter dated April 15, 2008 Manufacturer: Beijing Top Laser Technology Co., Ltd., Beijing, China. Firm initiated recall is ongoing.
REASON: An issue with the 585nm filter used with the NannoLight MP50. The filter may cause unwanted burning and should not be used for vascular lesion treatments.

PRODUCT:
1) Plastic Radiolucent Coaxial for 10gx118 (Catalog VC10118P). Recall # Z-1879-2009;
2) Plastic Radiolucent Coaxial for 10g x 140mm (VC10140P). Recall # Z-1880-2009;
3) MR Coaxial 10g x 140mm (VC10140MR). Recall # Z-1881-2009;
4) MR Coaxial 10g x 118mm (VC10118MR). Recall # Z-1882-2009
MANUFACTURER: Bard Peripheral Vas, Tempe, AZ, letter dated March 27, 2009. Firm initiated recall is ongoing.
REASON: Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure.

PRODUCT:
1) Baxter Minicap Extended Life PD Transfer Set (6") with Twist Clamp; six sets per carton; product code 5C4482. The set is used in disconnect applications and cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler juncture. Recall # Z-1893-2009;
2) Baxter Minicap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp; six sets per carton; product code 5C4483. The set is used in disconnect applications and cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler juncture. Recall # Z-1894-2009
MANUFACTURER: Baxter Healthcare Corp., Round Lake, IL, by telephone, fax or e-mail and letters dated July 2, 2009. Manufacturer: Baxter Healthcare Corp., Mountain Home, AR. Firm initiated recall is ongoing.
REASON: The peritoneal dialysis transfer set has a defective white sleeve twist clamp. The twist clamp will not open or close completely, which could cause leakage and lead to peritonitis.

PRODUCT:
Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. No labeling or Packaging. Used with Asahi Plasma Separators to perform therapeutic plasma exchange. Recall # Z-1897-2009
MANUFACTURER: Apheresis Technologies, Inc., Palm Harbor, FL, by letter February 11, 2009. Firm initiated recall is ongoing.
REASON: Apheresis Technologies, Inc. is taking the following Corrective Action: Modification of the Owners Manual Only for the PlasmaPro Plasma Pump Model PP-05. Operator's Manual will modify tubeset loading instructions so as to reduce possible loading error which might result in the tube being pulled into the pump head.

PRODUCT: Vertier Surgical Table, an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. Part Numbers: 0788100000 Standard table, 0788100001 Standard table with 5th wheel, 0788100000S SIDNE-enabled standard table, and 0788100001S SIDNE-enabled 5th wheel table. Recall # Z-1899-2009
MANUFACTURER: Recalling Firm: Stryker Communications Corp., Flower Mound, TX, by letter dated November 13, 2008. Manufacturer: Merivaara Corp., Lahti, Finland. Firm initiated recall is ongoing.
REASON: Surgical tables were produced using an unapproved tilt frame bushing.

PRODUCT: Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm) with Glidex hydrogel Coating Locking Pigtail and Radiopaque Marker, REF /Catalog No. 27-260 UPN; M001272600, Use before 2011-11, Sterilized with Ethylene Oxide Gas, Single Use Only. The catheter is designed for external and internal percutaneous drainage of the biliary system. Recall # Z-1901-2009
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Maple Grove, MN, letter dated July 1, 2009. Manufacturer: Boston Scientific Corp., Spencer, IN. Firm initiated recall is ongoing.
REASON: The labeling on the device does not match the labeling on the product packaging. Specifically, the packaging pouch for the product and outer carton labeling reflect that the device is a Flexima Biliary Catheter, which is correct, but the heat shrink inscription directly below the hub on the device indicates that it is a Flexima Nephrostomy device. The most likely consequence that is reasonably expected to occur as a result of this labeling issue is a clinically insignificant delay of the procedure if the physician decides to use another product/catheter.

PRODUCT: ConceiveEase ™, Fertility Friendly Lubricant. Intended Use: Personal Lubricant. Recall # Z-1904-2009
MANUFACTURER: Memphis Fertility Laboratory, Inc., Memphis, TN, by telephone and letter on July 10, 2009. Firm initiated recall is complete.
REASON: Product was marketed without a 510(k).

PRODUCT: Adapt AO, Akreos Advanced Optics Aspheric Lens. Recall # Z-1911-2009
MANUFACTURER: Bausch & Lomb, Inc., Rochester, NY, by telephone, telefax and letter beginning December 8, 2009. Firm initiated recall is ongoing.
REASON: Affected lenses were inadvertently shipped to Bausch & Lomb's European Logistics Center (ELC) prior to release authorization. Initial testing indicated the product did not meet release criteria for endotoxin limits.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of October 7, 2009:

CLASS II
PRODUCT: Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems. Recall # Z-0005-2009
MANUFACTURER: Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter on September 30, 2008. Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.
REASON: Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation.

PRODUCT:
1) Hologic Discovery series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics. Recall # Z-1725-2009;
2) Hologic Explorer series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics. Recall # Z-1726-2009;
3) Hologic QDR 4500 series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics. Recall # Z-1727-2009;
4) Hologic Delphi series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics. Recall # Z-1728-2009
MANUFACTURER: Hologic, Inc., Bedford, MA, by letter dated April 17, 2009. Firm initiated recall is ongoing.
REASON: System may not turn off at the end of the x-ray and cause additional x-ray exposure.

PRODUCT: 1) Dall Miles Cable Grip System; Catalog number 6704-0-210; The Dall-Miles Recon and Trauma Cable System provides the surgeon with a variety of methods for achieving trochanteric reattachment and for cerclage fixation. Recall # Z-1821-2009;
2) V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty. Recall # Z-1822-2009
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on June 18, 2009. Manufacturer: Stryker Ireland, Ltd., Orthopedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.
REASON: Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width.

PRODUCT: NX 2008 Central Monitoring System (CMS). Product code: E2FB6 Agfa's Computed Radiography Systems with NX Workstations are intended for use in providing diagnostic quality images to aid the physician with diagnosis. Recall # Z-1889-2009
MANUFACTURER: Recalling Firm: AGFA Corp., Greenville, SC, by letter on/about June 22, 2009. Manufacturer: Agfa HealthCare GMBH, Peissenberg, Germany. Firm initiated recall is ongoing.
REASON: After opening and closing a study on a Central Monitoring System while a study is still open on an in-room NX system, a problem of image mix-up can occur on the in-room NX system.

PRODUCT:
1) Sheridan Preformed Cuffed Tracheal Tube, Nasal 6.5, Catalog Number: 5-22313. Used for oral or nasal intubation for airway management. Recall # Z-1890-2009;
2) Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314. Used for oral or nasal intubation for airway management. Recall # Z-1891-2009
MANUFACTURER: Teleflex Medical, Durham, NC, by letters on or about July 6, 2009. Firm initiated recall is ongoing.
REASON: The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings.

PRODUCT
1) Boston Scientific Clipping Device, Resolution Clip, working length 155 cm, working channel 2.8 mm; Product codes M00522600 (1 clip) and M00522602 (20 clips). The Resolution Clip Device is a pre-loaded single-use clip on a flexible delivery system. It is placed into the gastrointestinal tract for the purpose of endoscopic marking, hemostasis, anchoring jejunal tubes and closure of lumenal perforations. Recall # Z-1895-2009;
2) Boston Scientific Clipping Device, Resolution Clip, working length 235 cm, working channel 2.8 mm; a) Product codes M00522610 (1 clip) and b) M00522612 (20 clips). The Resolution Clip Device is a pre-loaded single-use clip on a flexible delivery system. It is placed into the gastrointestinal tract for the purpose of endoscopic marking, hemostasis, anchoring jejunal tubes and closure of lumenal perforations. Recall # Z-1896-2009
MANUFACTURER: Recall Firm: Boston Scientific Corp., Quincy, MA, by letter dated June 17, 2009. Manufacturer: Medventure Technology Corp., Jeffersonville, IN. Firm initiated recall is ongoing.
REASON: The clip may not deploy or, if deployed, the clip may not release from the tissue.

PRODUCT: SmartPort CT Port Access System, Catalog number CT80STPD, AngioDynamics Incorporated The SmartPort CT Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for delivery of medications, nutritional supplementation, fluids, blood products, and sampling of blood. Recall # Z-1898-2009
MANUFACTURER: Angiodynamics, Inc., Manchester, GA, by letters on July 16, 2009. Firm initiated recall is ongoing.
REASON: The product may contain an incorrect size catheter and introducer.

PRODUCT:
1) Triathlon AR 4:1 Cutting Blocks - Size 1-8; Catalog Numbers: 6541-0-701, 6541-0-702, 6541-0-703, 6541-0-704, 6541-0-705, 6541-0-706, 6541-0-707, & 6541-0-708; Triathlon MIS Instruments; Non Sterile. The Triathlon AR 4:1 Cutting Blocks and the Triathlon MIS 4:1 Cutting Blocks are used to prepare the Femur (bone cuts) for the Triathlon femoral component. Recall # Z-1916-2009;
2) Triathlon MIS 4:1 Cutting Blocks - Size 1-8; Catalog Numbers: 6541-5-701, 6541-5-702, 6541-5-703, 6541-5-704, 6541-5-705, 6541-5-706, 6541-5-707, & 6541-5-708; Triathlon MIS Instruments; Non Sterile. The Triathlon AR 4:1 Cutting Blocks and the Triathlon MIS 4:1 Cutting Blocks are used to prepare the Femur (bone cuts) for the Triathlon femoral component. Recall # Z-1917-2009
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on February 12, 2008. Firm initiated recall is complete.
REASON: Triathlon Cutting Blocks did not assemble to the Triathlon Impactor/Extractor Handle.

PRODUCT:
Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 2660021119710 (new instrument) or 2660022119710 (refurbished instrument), and Stratus 6.0.0 Software Kit, product number 2660021133164. The Stratus OCT is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and measurement of the retina, retinal nerve fiber layer, macula, and optic disk. The Stratus OCT with Retinal Nerve Fiber Layer and Macula Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including, but not limited to, macular edema, central serous retinopathy, and glaucoma. Recall # Z-2048-2009
MANUFACTURER: Carl Zeiss Meditec Inc., Dublin, CA, by letter on July 2, 2009. Firm initiated recall is ongoing.
REASON: Mis-labeled image. A bug in version 6.0.0 software and 6.0.0 software kit used with Stratus OCT Model 3000 can produce a report that incorrectly labels OD or OS.

CLASS III
PRODUCT: Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog 12300. Collection and transportation of clinical specimens to the laboratory for microbiological examination when swab collection is appropriate. Recall # Z-1812-2009
MANUFACTURER: Remel, Inc., Lenexa, Kansas, by letters dated May 7, 2009. Firm initiated recall is ongoing.
REASON: Incorrect expiration date on the product.

PRODUCT: T2 Ankle Arthrodesis Nail Surgical Protocol, Catalog Number LT2AA-OT, Stryker Orthopedics. The Surgical Protocol instructs surgeons on proper surgical technique for the T2 Ankle Arthrodesis Nail. Recall # Z-1818-2009
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters, dated November 17, 2006. Firm initiated recall is complete.
REASON: Operative Surgical Technique was found to have a typographical error where hyphens were inadvertently omitted in incision lengths (i.e. 1520 cm should be 15-20 cm).
Please visit our websites at www.mdiconsultants.com for more information on mdi’s services, staff and items of interest.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 30, 2009:

CLASS II

PRODUCT: DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile; REF 96-0005. The device is used for total or unicompartmental knee arthroplasty and is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. The device is used as a Orthopedic knee implant. Recall # Z-1686-2009
MANUFACTURER: Recalling Firm: Depuy Orthopedics, Inc., Warsaw, IN, by email on May 7, 2009, and by letter dated May 7, 2009, and May 29, 2009. Manufacturer: DePuy (Ireland) Ltd., Co. Cork, Ireland. Firm initiated recall is ongoing.
REASON: There may be a crack on the lateral side of the condyle in the posterior chamber region.

PRODUCT: 1) GE Healthcare Signa Ovation 0.35T, Model Numbers: a) Ovation 1-3 (2276937), b) Ovation 4 (2377062-2, 2377062-5, 2377062-8, or 5118172), and c) Ovation 5 (5148725). The 0.35T Signa Ovation with Excite Magnetic Resonance system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The 0.35T Signa Ovation with Excite Magnetic Resonance system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the body including, but not limited to, the musculoskeletal, vascular, cardiac, and neuron systems. Recall # Z-1722-2009;2) Signa Openspeed 0.7T MR Systems, Model Numbers: Openspeed 3 (2138300-30), Openspeed 4 (2377062-5), Openspeed 5 (2377062-5, 2377062-30). Recall # Z-1723-2009
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated October 23, 2008 and a second letter dated March 5, 2009. Manufacturer: Yokogawa Medical Systems, Ltd., Tokyo, Japan. Firm initiated recall is ongoing.
REASON: GE Healthcare has identified a potential pinch point hazard on Ovation MR Scanner when using CTL Array XL Body Flex and Opened Body coil. A patient's hand may be pinched between the magnet bore ceiling cover and the CTL Array, XL Body Flex, or Open Body coil if the patient puts his/her hand on the top of the coil. Two injuries and four complaints filed. 2/20/09: Recall being expanded to include the OpenSpeed Systems.

PRODUCT: ACIST Automated Manifold Kit, REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico. The automated manifold kit is comprised of an injection manifold, a pressure transducer cartridge, a check valve, tubing (low, high and peristaltic pump), and a saline spike. This kit is designed for exclusive use with the ACIST CMS2000, E2000 Voyager and CVi models of Angiographic Contrast Delivery Systems. This kit is for single use. Recall # Z-1872-2009
MANUFACTURER: Recalling Firm: Acist Medical Systems, Eden Prairie, MN,
Manufacturer: NPA de Mexico S.A. de C.V., Tijuana, Mexico. Firm initiated recall is ongoing.
REASON: ACIST Medical Systems initiated a recall due to an increase in the incidence of field reports related to a bulge on the side and/or leaks in the bond of the 2.5 high-pressure tubing of BT2000 kits during a procedure which can result in unsatisfactory performance of the ACIST BT2000 Automated Manifold Kit.

PRODUCT: ArthroWand Saber 30 with Integrated Cable wand, Catalog number AC4330-01. Recall # Z-1900-2009
MANUFACTURER: ArthroCare Corp., Sunnyvale, CA, by letter on August 5, 2008. Firm initiated recall is ongoing.
REASON: Potential Sterility Loss-- Due to wearing or puncture in the Tyvek lid, the product may lose sterility.

PRODUCT:
1) Clinitron CII Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure. Recall # Z-1902-2009;
2) Clinitron Up-Lift" Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure. Recall # Z-1903-2009
MANUFACTURER: Hill-Rom Manufacturing, Inc., Charleston, SC, by letter dated February 2, 2009. Firm initiated recall is ongoing.
REASON: Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.

PRODUCT:
a) Specimen Gate Laboratory, Product Code: 5002-0180, Software Version: 1.2 and 1.3. The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow viewing and management of assay results. Recall # Z-1905-2009;
b) Specimen Gate Lab - MSMS Data Suite, Product Code: 5002-0310. The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow viewing and management of assay results. Recall # Z-1906-2009
MANUFACTURER: Recalling Firm: Perkin Elmer, Waltham MA, by fax on January 15, 2009. Manufacturer: PerkinElmer Life and Analytical Sciences, Wallac, OY, Turku, Finland. Firm initiated recall is ongoing.
REASON If Result Codes are used and if they are manually edited, they are correct unless the laboratory specifically uses the View Assay button in the Specimen History screen to open another assay, and then returns back to the original assay.

PRODUCT: BHM Combi Sling, 100% Polyester Shell/100% Polyester Strap; soft polyester net fabric sling for ceiling and floor patient lifts; made in China. Part 626002: Combi Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; Part 626002M: Combi Mesh Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; Part 626002C Combi Sling Deluxe Small, capacity 20-68 kg, 45-150 lbs; Part 626002C-M Combi Sling Mesh Deluxe Small, capacity 20-68 kg, 45-150 lbs; Part 626003: Combi Deluxe - Large, capacity 113-272 kg, 250-600 lbs; Part 626003M: Combi Mesh Deluxe - Large, capacity 113-272 kg, 250-600 lbs; and Part 626003X: Combi Oversize Heavy Duty, capacity 113-272 kg, 250-600 lbs. Between 2004 and 2006, the Combi Slings were labeled as BHM Medical Inc. (800) 868-0441, 100% Polyester Shell/100% Nylon Strap, made in Canada. Prior to 2004, the slings were labeled Medi-Man, 100% Polyester Shell, made in Canada. The accessory is intended to be used with patient lift for the transfer of patient in hospitals, nursing homes, or other health care facilities by trained caregivers. Recall # Z-1990-2009
MANUFACTURER: B.H.M. Medical, Inc., Magog, Canada, by letters dated April 15, 2009. Firm initiated recall is ongoing.
REASON: Premature failure of the stitching at the junction of the shoulder strap and sling body of the BHM/Medi-Man Combi Sling used with patient lifts.

PRODUCT:
1) Empty M9 aluminum oxygen cylinders packaged in shipping containers (1 per container) labeled as: Product #0022-57P, Desc: CYL 02 ALUM 240 LITER, Catalog #31-10-2012. Recall # Z-2031-2009;
2) Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-44P, CYL 02 ALUM 400 LITER, Catalog #31-10-0014. Recall # Z-2032-2009;
3) Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-58 P, Desc CYL 02 ALUM 400 LITER, Catalog #31-10-2014. Recall # Z-2033-2009;
4) Empty Jumbo D aluminum oxygen cylinders, 72 cylinders per skid labeled as: Product #0022-96D, Desc: CYL 02, JUMBO D, A VLV, 72/SKID, Catalog #31-10-0117. Recall # Z-2034-2009;
5) Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-96P, Desc CYL 02, JUMBO D, W/TYPE B POST, Catalog #31-10-2017. Recall # Z-2035-2009;
6) Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as: Product 0022-96, Desc CYL 02 ASSY., 637.2 LITER, Catalog #31-10-0017. Recall # Z-2036-2009;
7) Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #65261-E, Desc D PORTABLE W STRAIGHT POS, Catalog #65261-E. Recall # Z-2037-2009;
8) First Responder Kit containing a 240-liter aluminum oxygen cylinder with individually packaged regulator, cannula, and bag mask resuscitator, all packaged in a shipping container labeled as: Product #L903, Desc FIRST RESPONDER KIT, Catalog #L903. Recall # Z-2038-2009
MANUFACTURER: Allied Healthcare Products, Inc., St. Louis, MO, by letters dated May 15, 2009, June 1, 2009 and June 17, 2009. Firm initiated recall is ongoing.
REASON: Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.

PRODUCT: Leckey 4-Point Pelvic Harness Belts, catalog 081326990. Sold as a component of the following chairs: a) Leckey Contour Advance Seat, Size 1, catalog 081117209; b) Leckey Contour Advance Seat, Size 2, catalog 081117217; c) Leckey Squiggles Saddle Seat, catalog 081326941; d) Leckey Early Sitting System, catalog 081395193. Recall # Z-2040-2009
MANUFACTURER: Recalling Firm: Patterson Medical Holdings, Inc., Bolingbrook, IL, by letters dated April 17, 2009. Manufacturer: James Leckey Design, Ltd., Northern Ireland, Belfast, United Kingdom. Firm initiated recall is ongoing.
REASON: The plastic buckles on the hip belts of the 4-Point Pelvic Harness may break.

PRODUCT:
1) EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A. Recall # Z-2054-2009;
2) EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and V12-04A. Recall # Z-2055-2009
MANUFACTURER: Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letter on May 12, 2008. Manufacturer: Hitachi Medical Corp., Tokyo, Japan. Firm initiated recall is complete.
REASON: The firm's parent company discovered a DICOM UID (Universal Identifier) code mix-up which can occur due to a software error. This error can cause the images from two (2) different patient scans to become intermingled and consequently, labeled incorrectly.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 23, 2009:

CLASS II
PRODUCT: Twin-Pass Dual Access Catheter, REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Pyrogenic. The TWIN-PASS catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents. Recall # Z-1712-2009
MANUFACTURER: Vascular Solutions, Inc., Maple Grove, MN, by letter dated July 6, 2009. Firm initiated recall is ongoing.
REASON: Three occurrences of Twin-Pass catheters containing a piece of PTFE beading material in the OTW lumen have been reported to Vascular Solutions. The PTFE beading material is a processing aide used during hydrophilic coating. The beading is to be removed followed by a visual inspection prior to packaging.

PRODUCT:
1) CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3604, O.D. Size: 36mm, Neck Length: -3.5mm, Taper: SLT, Sterile R, 1 each, Rx only, The CONSERVE Total Femoral Head is indicated for use in total hip arthroplasty for reduction of relief of pain and/or improved hip function in skeletally mature patients. Recall # Z-1715-2009;
2) CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3635, O.D. Size: 36mm, Neck Length: +3.5mm, Taper: SLT, Sterile R, 1 each, Rx only. The CONSERVE Total Femoral Head is indicated for use in total hip arthroplasty for reduction of relief of pain and/or improved hip function in skeletally mature patients. Recall # Z-1716-2009
MANUFACTURER: Wright Medical Technology Inc., Arlington, TN, by letter dated May 14, 2009. Firm initiated recall is ongoing.
REASON: Incorrect packaging, swapped sizes.

PRODUCT: Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion. Recall # Z-1721-2009
MANUFACTURER: Med Tec Inc., Orange City, IA, by letter dated March 6, 2009 and by e-mail or telephone beginning March 16, 2009 and April 20, 2009. Firm initiated recall is ongoing.
REASON: The silkscreened indexing scale was reversed.

PRODUCT: Bausch & Lomb, Boston Conditioning Solution, Original Formula, For Rigid Gas Permeable Contact Lenses, 1 fl. oz. (30 ml), Item Number: 7474G. Recall # Z-1735-2009
MANUFACTURER: Recalling Firm: Bausch & Lomb Inc, Rochester, NY, by letter on dated June 26, 2009. Manufacturer: Bausch & Lomb Inc., Greenville, SC. Firm initiated recall is ongoing.
REASON: The product failed to meet one of the shelf life specifications at the end of the expiry period.

PRODUCT:
1) Stryker PainPump catheter and split introducer needle, sterile; REF 500-23. Recall # Z-1736-2009;
2) Stryker ExFen 2.5" extended fenestration catheter set for PainPump, sterile; REF 500-25. Recall # Z-1737-2009;
3) Stryker ExFen 5.0" extended fenestration catheter set for PainPump, sterile; REF 500-50. Recall # Z-1738-2009;
4) Stryker PainPump base kit, 120 mL infusion kit, sterile; REF 500-100. Recall # Z-1739-2009;
5) Stryker PainPump, 5-day infusion kit, 120 mL infusion kit (0.83 mL/hr), sterile; REF 500-110. Recall # Z-1740-2009;
6) Stryker PainPump, 2-day infusion kit, 120 mL infusion kit (2.08 mL/hr), sterile; REF 500-120. Recall # Z-1741-2009;
7) Stryker PainPump, 2-day infusion kit with ExFen 2.5", 120 mL infusion kit (2.08 mL/hr), sterile; REF 500-120-25. Recall # Z-1742-2009;
8) Stryker PainPump, 2-day infusion kit with ExFen 5.0", 120 mL infusion kit (2.08 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 500-120-50. Recall # Z-1743-2009;
9) Stryker PainPump, 1-day infusion kit, 120 mL infusion kit (4.16 mL/hr), sterile; REF 500-140. Recall # Z-1744-2009;
10) Stryker PainPump, two site infusion kit with ExFen 2.5", 120 mL infusion kit, sterile; REF 500-166-25. Recall # Z-1745-2009;
11) Stryker PainPump, two site infusion kit with ExFen 5.0", 120 mL infusion kit, sterile; REF 500-166-50. Recall # Z-1746-2009;
12) Stryker PainPump, two site infusion set, sterile; REF 500-200. Recall # Z-1747-2009;
13) Stryker PainPump, two site infusion set, sterile; REF 500-250. Recall # Z-1748-2009;
14) Stryker PainPump, 270 mL base infusion kit, sterile; REF 0501-100-000. Recall # Z-1749-2009;
15) Stryker PainPump, 270 mL infusion kit (2.08 mL/hr), sterile; REF 0501-120-000. Recall # Z-1750-2009;
16) Stryker PainPump, 270 mL infusion kit (4.16 mL/hr), sterile; REF 0501-140-000. Recall # Z-1751-2009;
17) Stryker PainPump, 270 mL infusion kit (4.16 mL/hr) with ExFen 2.5", sterile; REF 0501-140-025. Recall # Z-1752-2009;
18) Stryker PainPump, 270 mL infusion kit (2.08 cc/hr) with ExFen 5.0", sterile; REF 501-140-50. Recall # Z-1753-2009;
19) Stryker PainPump, 270 mL two site infusion kit with ExFen 2.5", sterile; REF 0501-416-025. Recall # Z-1754-2009;
20) Stryker PainPump, 270 mL two site infusion kit with ExFen 5.0", sterile; REF 0501-416-050. Recall # Z-1755-2009;
21) Stryker PainPump2, 250 mL pre-set PainPump with luer lock tubing set, 2.5 inch ExFen and standard catheter, sterile; REF 521-125. Recall # Z-1756-2009;
22) Stryker PainPump2, 250 mL pre-set PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile; REF 521-155. Recall # Z-1757-2009;
23) Stryker PainPump ExFen, sterile; REF 525-10. Recall # Z-1758-2009;
24) Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen 2-site catheter set, sterile; REF 525-25. Recall # Z-1759-2009;
25) Stryker PainPump2, 250 mL PainPump with 5.0 inch ExFen 2-site catheter set, sterile; REF 525-50. Recall # Z-1760-2009;
26) Stryker PainPump2, 250 mL PainPump with luer lock tubing set, 2.5 inch ExFen and standard catheter, sterile; REF 525-125. Recall # Z-1761-2009;
27) Stryker PainPump2, 250 mL PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile; REF 525-155. Recall # Z-1763-2009;
28) Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen catheter and luer lock tubing set, sterile; a) REF 525-156, b) REF 525-157 and c) REF 525-158. Recall # Z-1763-2009;
29) Stryker PainPump2, 2-site tube set with standard catheter, sterile; REF 525-200-2. Recall # Z-1764-2009;
30) Stryker PainPump2, 2-site tube set with 2.5" ExFens, sterile; REF 525-200-25. Recall # Z-1765-2009;
31) Stryker PainPump2, 2-site tube set with 5.0" ExFen, sterile; REF 525-200-50. Recall # Z-1766-2009;
32) Stryker PainPump2 ExFen 2.5, 2.5" extended fenestration catheter set for PainPump2, sterile; REF 525-250. Recall # Z-1767-2009;
33) Stryker PainPump2 ExFen 2.5, 2.5" catheter set for PainPump2, sterile; REF 525-251. Recall # Z-1768-2009;
34) Stryker PainPump2 ExFen 5, 5" extended fenestration catheter set for PainPump2, sterile; REF 525-500. Recall # Z-1769-2009;
35) Stryker PainPump2 ExFen 5, 5" catheter set for PainPump2, sterile; REF 525-501. Recall # Z-1770-2009;
36) Stryker standard catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-001-000. Recall # Z-1771-2009:
37) Stryker 5.0 catheter set for PainPump2 and AutoFuser PainPump, sterile; REF 0537-005-000. Recall # Z-1772-2009;
38) Stryker 10.0 catheter set for PainPump2 and AutoFuser PainPump, sterile; REF 0537-010-000. Recall # Z-1773-2009;
39) Stryker 2.5 catheter set for PainPump2 and AutoFuser PainPump, sterile; REF 0537-025-000. Recall # Z-1774-2009;
40) Stryker 5.0 catheter set for PainPump2 and AutoFuser PainPump, sterile; REF 0537-205-000. Recall # Z-1775-2009;
41) Stryker dual 10.0 catheter set for PainPump2 and AutoFuser PainPump, sterile; REF 0537-210-000. Recall # Z-1776-2009;
42) Stryker dual 2.5 catheter set for PainPump2 and AutoFuser PainPump, sterile; REF 0537-225-000. Recall Z-1777-2009;
43) Stryker PainPump2, 400 mL PainPump with 2.5 inch ExFen 2-site catheter set, sterile; REF 540-25. Recall # Z-1778-2009;
44) Stryker PainPump2, 400 mL PainPump with 5.0 inch ExFen 2-site catheter set, sterile; REF 540-50. Recall # Z-1779-2009;
45) Stryker PainPump2, 400 mL PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile; REF 540-155. Recall # Z-1780-2009;
46) Stryker PainPump2, 400 mL pre-set PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile; REF 541-155. Recall # Z-1781-2009;
47) Stryker PainPump, standard antimicrobial silver catheter kit, sterile; REF 0555-001-000. Recall # Z-1782-2009;
48) Stryker PainPump ExFen, 2.5 in. antimicrobial silver ExFen catheter kit, sterile; REF 0555-002-000. Recall # Z-1783-2009;
49) Stryker PainPump ExFen, 5.0 in. antimicrobial silver ExFen catheter kit, sterile; REF 0555-005-000. Recall # Z-1784-2009;
50) Stryker PainPump ExFen, 10.0 in. antimicrobial silver ExFen catheter kit, sterile; REF 0555-010-000. Recall # Z-1785-2009;
51) Stryker PainPump ExFen, 2.5 in. dual site antimicrobial silver ExFen catheter, sterile; REF 0555-202-000. Recall # Z-1786-2009;
52) Stryker PainPump ExFen, 5.0 in. dual site antimicrobial silver ExFen catheter, sterile; REF 0555-205-000. Recall # Z-1787-2009;
53) Stryker PainPump ExFen, 10.0 in. dual site antimicrobial silver ExFen catheter, sterile; REF 0555-210-000. Recall # Z-1788-2009
MANUFACTURER: Recalling Firm: Stryker Instruments Div. of Stryker Corp., Kalamazoo, MI, by letter dated June 16, 2009. Manufacturer: Medisize Ireland Ltd, Donegal, Ireland. Firm initiated recall is ongoing.
REASON: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.

PRODUCT:
1) Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF 7961810; 12MM, REF 7961812; 14MM, REF 7961814; 16MM, REF 7961816; 18MM, REF 7961818; 20MM, REF 7961820; Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1796-2009;
2) Medtronic INTREPID Spinal System SPACER, 32X23, 12 DEG, Size: 10MM, Part Number: REF 7961210; 12MM, REF 7961212; 14MM, REF 7961214; 16MM, REF 7961216; 18MM, REF 7961218; 20MM, REF 7961220; Rx only, STERILE R The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1797-2009;
3) Medtronic INTREPID Spinal System SPACER M 37X27, 8 DEG, Size 10MM, Part Number: REF 7962810; 12MM, REF 7962812; 14MM, REF 7962814; 16MM, REF 7962816; 18MM, REF 7962818; 20MM, REF 7962820; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1798-2009;
4) Medtronic INTREPID Spinal System SPACER M 37X27, 12 DEG, Size: 10MM, Part Number: REF 7962210; 12MM, REF 7962212; 14MM, REF 7962214; 16MM, REF 7962216; 18MM, REF 7962218; 20MM, REF 7962220; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1799-2009;
5) Medtronic INTREPID Spinal System SPACER L 42X30, 8 DEG, Size: 10MM: Part Number: REF 7963810; 12MM, REF 7963812; 14MM, REF 7963814; 16MM, REF 7963816; 18MM, REF 7963818; 20MM, REF 7963820; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1800-2009;
6) Medtronic INTREPID Spinal System SPACER L 42X30, 12 DEG, Size: 10MM, Part Number: REF 7963210; 12MM, REF 7963212, 14MM, REF 7963214; 16MM, REF 7963216; 18MM, REF 7963218; 20MM, REF 7963220; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1801-2009;
7) Medtronic INTREPID Spinal System Coverplate, size: Small, Part Number: REF 7961330; medium, REF 7962330; large, REF 7963330; STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1802-2009;
8) Medtronic SOFAMOR DANEK INTREPID SPINAL SYSTEM, 5.5MM TAPERED SCREW, Length: 20MM, , Part Number: REF 7960020; 25MM, REF 7960025, 30MM, REF 7960030; and 35MM, REF 7960035; QTY: 1 EA, NON-STERILE, Rx only, MATL: TITANIUM ALLOY, Manufactured at: Warsaw, Indiana USA. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1803-2009
MANUFACTURER: Medtronic Sofamor Danek USA Inc., Memphis, TN, by telephone starting February 6, 2009 and letter dated April 2009. Manufacturer: Medtronic Sofamor Danek Deggendorf GmbH, Bavaria, Germany. Firm initiated recall is ongoing.
REASON: The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.

PRODUCT:
1) Stryker Reflex Hybrid Level Anterior Cervical Plate; Non Sterile. All Product with the following Catalog Number/Description: 48650112, Reflex Hybrid one-level plate, size 12mm; 48650114m size 14 mm; 48650116, 16 mm; 48650118, size 18mm; 48650120, size 20 mm; 48650122, size 22 mm. 48650224, Reflex Hybrid Two-Level Plate, size 24 mm; 48650226, size 26 mm; 48650228, size 28 mm; 48650230, size 30 mm; 48650232, size 32 mm; 48650234, size 34 mm; 48650237, size 37 mm; 48650240, size 40 mm; 48650243, size 43 mm; 48650246, size 46 mm. 48650339, Reflex Hybrid Three-Level Plate, Size 39 mm; 48650342, size 42mm; 48650345, size 45 mm; 48650348, size 48 mm; 48650351, size 51 mm; 48650354, size 54 mm; 48650357, size 57 mm; 48650360, size 60 mm; 48650363, size 63 mm; 48650366, size 66 mm; 48650369, size 69 mm. 48650460, Reflex Hybrid four-Level Plate, size 60 mm; 48650464, size 64 mm; 48650468, size 68 mm; 48650472, size 72 mm; 48650476, size 76 mm; 48650489, size 80 mm; 48650484, size 84 mm. Recall # Z-1958-2009;
2) Stryker Reflex Hybrid variable self-drilling screw. Non Sterile. All Product with the following Catalog Number/ Description: 48664010, Variable Angle Bone Screw Self Drilling, Diameter 4.0 x 10 mm; 48664012, diameter 4.0 x 12 mm; 48604014, diameter 4.0 x 14 mm; 48664016, diameter 4.0 x 16 mm; 48664018, diameter 4.0 x 18 mm. Recall # Z-1959-2009;
3) Stryker Reflex Hybrid Variable Self-Tapping Screw. Non Sterile. All Product with the following Catalog Number/Description: 48684012, Variable Angle Bone Screw, diameter 4.0 x 10 mm; 48684012, diameter 4.0 x 12 mm; 48684014, diameter 4.0 x 14 mm; 48684018, diameter 4.0 x 18 mm; 48684020, diameter 4.0 x 20 mm; 48684512, diameter 4.5 x 12 mm; 48684516, diameter 4.5 x 14 mm; 48684516, diameter 4.5 x 16 mm; 48684518, diameter 4.5 x 18 mm; 48684520, diameter 4.5 x 20 mm. Recall # Z-1960-2009
MANUFACTURER: Recalling Firm: Stryker Spine, Allendale, NJ, by letter dated June 14, 2006. Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is complete.
REASON: Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 16, 2009:

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
****CORRECTION****
Enforcement Report dated September 2, 2009, Recall # Z-1958-2009. Recall Firm/Manufacturer: Stryker Spine, Allendale, NJ, by letter dated June 14, 2009 – the date should be June 14, 2006.

PRODUCT:
1) Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, and P107. Recall # Z-1678-2009;
2) Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110; the following models are not available in the US: models F102, F110. Recall # Z-1679-2009
MANUFACTURER: Boston Scientific CRM Corp., Saint Paul, MN, by letter, dated March 23, 2009. Firm initiated recall is ongoing.
REASON: Lead connection issues or fracture increases probability of inappropriate therapy: Inappropriate shocks, inappropriate anti-tachycardia pacing therapy, or inappropriate inhibition of needed bradycardia pacing therapy.

PRODUCT: American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery. Recall # Z-1808-2009
MANUFACTURER: American Optisurgical Inc., Lake Forest, CA, by e-mail on April 2, 2009. Firm initiated recall is complete.
REASON: Device operation interrupted: A software bug causes Phaco to stop when vacuum goes above 300 mmHg while in Multi Burst mode. Use of this product at the parameters specified above could lead to a delay in surgery that might present a health risk.

PRODUCT:
1) Stryker 100 mL AutoFuser PainPump, single site continuous, 1.0 mL/hr, 1 x 2.5” ExFen catheter, sterile REF 0531-100-025. Infusion pump for pain medication. Recall # Z-1823-2009;
2) Stryker 100 mL AutoFuser PainPump, single site continuous, 2.0 mL/hr, sterile, REF 0531-200-000. Recall # Z-1824-2009;
3) Stryker 100 mL AutoFuser PainPump, single site continuous, 2.0 mL/hr, 1 x 2.5" standard catheter, sterile; REF 0531-200-001. Recall # Z-1825-2009;
4) Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 2.5" catheter, sterile, REF 0531-200-025. Recall # Z-1826-2009;
5) Stryker 100 mL AutoFuser PainPump, dual site continuous, 2 mL/hr, sterile, REF 0531-200-200. Recall # Z-1827-2009;
6) Stryker 100 mL AutoFuser PainPump, dual site continuous, 2 mL/hr, 2 x 2.5 in. catheters, sterile, REF 0531-200-250. Recall # Z-1828-2009;
7) Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, sterile, REF 0531-216-000. Recall # Z-1829-2009;
8) Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, standard catheter, sterile, REF 0531-216-001. Recall # Z-1830-2009;
9) Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0531-216-025. Recall # Z-1831-2009;
10) Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, 1 x 5.0 in. catheter, sterile, REF 0531-216-050. Recall # Z-1832-2009;
11) Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, sterile, REF 0532-200-000. Recall # Z-1833-2009;
12) Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, standard catheter, sterile, REF 0532-200-001. Recall # Z-1834-2009;
13) Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 2.5 in. catheter, sterile, REF 0532-200-025. Recall # Z-1835-2009;
14) Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 5.0 in. catheter, sterile, REF 0532-200-050. Recall # Z-1836-2009;
15) Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 2 mL bolus, 60 minute bolus refill, sterile, REF 0532-226-000. Recall # Z-1837-2009;
16) Stryker 275 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0532-226-025. Recall # Z-1838-2009;
17) Stryker 275 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 5.0 in. catheter, sterile, REF 0532-226-050. Recall # Z-1839-2009;
18) Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, sterile, REF 0532-400-200. Recall # Z-1840-2009;
19) Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10 in. catheters, sterile, REF 0532-400-210. Recall # Z-1841-2009;
20) Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 2.5 in. catheter, sterile, REF 0532-400-225. Recall # Z-1842-2009;
21) Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 5.0 in. catheters, sterile, REF 0532-400-250. Recall # Z-1843-2009;
22) Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, sterile, REF 0532-500-000. Recall # Z-1844-2009;
23) Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, standard catheter, sterile, REF 0532-500-001. Recall # Z-1845-2009;
24) Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 1 x 2.5 in. catheter, sterile, REF 0532-500-025. Recall # Z-1846-2009;
25) Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 1 x 5.0 in. catheter, sterile, REF 0532-500-050. Recall # Z-1847-2009;
26) Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 2 mL bolus, 60 minute bolus refill, sterile, REF 0532-526-000. Recall # Z-1848-2009;
27) Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0532-526-025. Recall # Z-1849-2009;
28) Stryker 275 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 5.0 in. catheter, sterile, REF 0532-526-050. Recall # Z-1850-2009;
29) Stryker 550 mL AutoFuser PainPump, single site continuous, 10 mL/hr, sterile, REF 0535-100-000. Recall # Z-1851-2009;
30) Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, sterile, REF 0535-400-200. Recall # Z-1852-2009;
31) Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10.0 in. catheters, sterile, REF 0535-400-210. Recall # Z-1853-2009;
32) Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 2.5 in. catheters, sterile, REF 0535-400-225. Recall # Z-1854-2009;
33) Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 5.0 in. catheters, sterile, REF 0535-400-250. Recall # Z-1855-2009;
34) Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, 60 minute bolus refill, sterile, REF 0535-426-000. Recall # Z-1856-2009;
35) Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 10.0 in. catheter, sterile, REF 0535-426-010. Recall # Z-1857-2009;
36) Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0535-426-025. Recall # Z-1858-2009;
37) Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 5.0 in. catheter, sterile, REF 0535-426-050. Recall # Z-1859-2009;
38) Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, sterile, REF 0535-500-000. Recall # Z-1860-2009;
39) Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, 1 x 10.0 in. catheter, sterile, REF 0535-500-010. Recall # Z-1861-2009;
40) Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, 1 x 5.0 in. catheter, sterile, REF 0535-500-050. Recall # Z-1862-2009;
41) Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, sterile, REF 0535-600-000. Recall # Z-1863-2009;
42) Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, sterile, REF 0535-626-000. Recall # Z-1864-2009;
43) Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 10.0 in. catheter, sterile, REF 0535-626-010. Recall # Z-1865-2009;
44) Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0535-626-025. Recall # Z-1866-2009;
45) Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 5.0 in. catheter, sterile, REF 0535-626-050. Recall # Z-1867-2009;
46) Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr with 2.5 in. antimicrobial silver ExFen catheter, sterile, REF 8531-200-025. Recall # Z-1868-2009
MANUFACTURER: Recalling Firm: Stryker Instruments Div. of Stryker Corp., Kalamazoo, MI, by letter dated May 14, 2009. Manufacturer: Ace Medical, Seoul, Korea, Republic Of (South). Firm initiated recall is ongoing.
REASON: Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.

PRODUCT: Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon tip or cone distal tips, straight or right angle, available with proximal end fittings for either 1/4 inch connector or male luer fitting, Model numbers: 210800, 210801, 210802, 210803, 210804, 210805, 210806, 210807, 210810, 210811, 210812, 210813, 210814, 210815, 210816, 210817, 215800, 215802, 215803, 215804, 215805, 215806, 215807, 215810, 215811, 215812, 215813, 215814, 215815, 215816, and 215817. Recall # Z-1869-2009
MANUFACTURER: Recalling Firm: Maquet Cardiovascular, San Jose, CA, by letter on May 19, 2009. Manufacturer: Maquet Cardiopulmonary Ag, Hirrlingen, Germany. Firm initiated recall is ongoing.
REASON: Undeclared allergen: Products are missing the warning label declaring that the products contain natural rubber latex.

PRODUCT: GE Healthcare, Uni-Circuit Kit, Adult, Disposable, 1.8 m/72 in, REF M1089028, M1087972, M1087975, M1126445, M1127508, M1127509, M1129780, M1129781, M1130230, M1137805, M1137199, M1145542, M1170604, M1151662, M1152224, M1158990, M1100486, M1122080, M1126444, M1163003, M1163255 M1132533, M1133966, M1170051, M1135144, M1139485, M1118627, M1118628, M1145406, M1147298, M1137811, M1152651, M1160275. Package of 20 pieces, Latex Free. Breathing circuit for use with anesthesia machine or ventilator. Z-1870-2009
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated June 5, 2009. Manufacturer: Vincent Raya (Dong Guan) Electronics Co., LTD, Guang Dong, China. Firm initiated recall is ongoing.
REASON: Breathing circuit inner tube may separate from the rigid connectors under certain conditions. A separation of the inner tube from the connector may prevent adequate gas flow (O2, N2O and anesthetic agents) to the patient. A separation can also cause CO2 re-breathing. This could lead to hypoxia and/or hypercarbia and inadequate anesthesia delivery.

PRODUCT:
1) Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation. Recall # Z-1876-2009;
2) Boston Scientific, LeVeen Needle Electrode, 25 cm, 5.0 cm, sterile; REF M001262170. For tissue coagulation. Recall # Z-1877-2009
MANUFACTURER: Boston Scientific Corp., Spencer, In, by letter dated July 6, 2009. Firm initiated recall is ongoing.
REASON: The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.

PRODUCT: Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) Fixation Hinge Kit, REF 101638, for external fixation of finger joint. Recall # Z-2027-2009
MANUFACTURER: Smith & Nephew Inc., Memphis, TN, by letter and e-mail on January 23, 2009 and June 6, 2009. Firm initiated recall is ongoing.
REASON: Hinge failure: The product is cracking or breaking during use.

PRODUCT : Boston Scientific, Contour SE Microspheres, for tumor treatment. UPN Codes: Description: M001761101 Contour SE/100-300/1mL/2vials, M001761122 Contour SE/100-300/1mL/5vials, M001761141 Contour SE/100-300/2mL/2vials, M001761162 Contour SE/100-300/2mL/5vials, M001761201 Contour SE/300-500/1mL/2vials, M001761222 Contour SE/300-500/1mL/5vials, M001761241 Contour SE/300-500/2mL/2vials, M001761262 Contour SE/300-500/2mL/5vials, M001761301 Contour SE/500-700/1mL/2vials, M001761322 Contour SE/500-700/1mL/5vials, M001761341 Contour SE/500-700/2mL/2vials, M001761362 Contour SE/500-700/2mL/5vials, M001761401 Contour SE/700-900/1mL/2vials, M001761422 Contour SE/700-900/1mL/5vials, M001761441 Contour SE/700-900/2mL/2vials, M001761462 Contour SE/700-900/2mL/5vials, M001761501 Contour SE/900-1200/1mL/2vials, M001761522 Contour SE/900-1200/1mL/5vials, M001761541 Contour SE/900-1200/2mL/2vials, M001761562 Contour SE/900-1200/2mL/5vials. Recall # Z-2109-2009
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Maple Grove, MN, by letter dated August 28, 2009. Manufacturer: Boston Scientific Cork, Ltd., Cork, Ireland. Firm initiated recall is ongoing.
REASON: All affected product is packaged within a vial. Boston Scientific has determined that, for affected products, the sterile barrier in the packaging (pouch) that contains the vial may be breached. The breach of sterility could lead to a contamination of the sterile field which may pose a risk for adverse health effects for the patient including bacteremia and, in the most extreme cases, sepsis.

PRODUCT:
1) Bard Access Systems, Inc., Gauderer Genie* II PEG (Percutaneous Endoscopic Gastrostomy) Safety System Ponsky "Pull" Placement Technique REF 000373, 20F, Sterile. Recall # Z-2179-2009;
2) Bard Access Systems, Inc., Gauderer Genie* II PEG (Percutaneous Endoscopic Gastrostomy) Safety System Guidewire Placement Technique REF 000375, 20F, Sterile. Recall # Z-2180-2009;
3) Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull" REF 003025, 16F, Sterile. Recall # Z-2181-2009;
4) Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull" REF 003027, 28F, Sterile. Recall # Z-2182-2009;
5) Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire", REF 003028, 28F, Sterile. Recall # Z-2183-2009;
6) Bard Access Systems, Inc., FASTRAC "Pull" Gastric Access Port Kit, REF 005729, 20F, Sterile. Recall # Z-2184-2009;
7) Bard Access Systems, Inc., FASTRAC* "Pull" Gastric Access Port Safety System, REF 006033, 20F, Sterile. Recall # Z-2185-2009;
8) Bard Access Systems, Inc., FASTRAC* Guidewire Gastric Access Port Safety System, REF 006034, 20F, Sterile. Recall # Z-2186-2009;
9) Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull", REF 006035, 20F, Sterile. Recall # Z-2187-2009;
10) Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007023, 20F, Sterile. Recall # Z-2188-2009;
11) Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Safety System, REF 007024, 20F, Sterile. Recall # Z-2189-2009;
12) Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Safety System, REF 007030, 24F, Sterile. Recall # Z-2190-2009;
13) Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Safety System, REF 007035, 24F, Sterile. Recall # Z-2191-2009;
14) Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007036, 24F, Sterile. Recall # Z-2192-2009;
15) Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007037, 16F, Sterile. Recall # Z-2193-2009;
16) Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007038, 14F, Sterile. Recall # Z-2194-2009;
17) Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007050, 24F, Sterile. Recall # Z-2195-2009;
18) Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007052, 16F, Sterile. Recall # Z-2196-2009;
19) Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007056, 14F, Sterile. Recall # Z-2197-2009;
20) Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007078, 20F, Sterile. Recall #Z-2198-2009;
21) Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Kit, REF 007082, 20F, Sterile. Recall #Z-2199-2009;
22) Bard Access Systems, Inc., Ponsky* Deluxe "Pull" PEG (Percutaneous Endoscopic Gastrostomy) Kit with Soft Silicone Retention Dome, REF 000627, 20F. Recall # Z-2200-2009;
23) Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy) System with Soft Silicone Retention Dome, REF 000628, 20F. Recall # Z-2201-2009;
24) Bard Access Systems, Inc., Ponsky* Deluxe "Pull" PEG (Percutaneous Endoscopic Gastrostomy) Kit with Soft Silicone Retention Dome, Sterile, Rx only, REF 000792, 20F. Recall # Z-2202-2009;
25) Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy) System with Soft Silicone Retention Dome, Sterile, Rx only, REF 000793, 20F. Recall # Z-2203-2009;
26) Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull", REF 003029, 20F, Sterile. Recall # Z-2204-2009;
27) Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire" REF 003030, 20F, Sterile. Recall # Z-2205-2009;
28) Bard Access Systems, Inc., FASTRAC Guidewire Gastric Access Port Kit, REF 005739, 20F, Sterile. Recall # Z-2206-2009;
29) Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire", REF 006036, 20F, Sterile. Recall # Z-2207-2009
MANUFACTURER: Recalling Firm: C.R. Bard Access Systems, Inc., Salt Lake City, UT, by e-mail on December 4, 2008. Manufacturer: Bard Puerto Rico, Las Piedras, PR. Firm initiated recall is ongoing.
REASON: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 9, 2009

CLASS I
PRODUCT: Gel Filled Teethers, various shapes and sizes, marketed under the names: Nuby, Cottontails, and Playskool. This product is intended for use by infants for medical purposes to soothe gums during the teething process. UPC codes: 48526-00451 Nuby 48526-00452 Nuby 48526-00453 Nuby 48526-00454 Nuby 48526-00455 Nuby 48526-00459 Nuby 48526-00467 Nuby 48526-00472 Nuby 48526-00473 Nuby 48526-00482 Nuby 48526-00483 Nuby 48526-00487 Nuby 48526-00490 Nuby 48526-00519 Nuby 48526-00521 Nuby 48526-87115 Cottontails 48526-91511 Playskool 48526-91660 Cottontails, Recall # Z-1878-2009
MANUFACTURER: Recalling Firm: Luv N' Care Ltd, Monroe LA, by telephone and email, and followed with letters and Press Release on July 17, 2009. Manufacturing Firm 1: Elung Industrial Co. Ltd, Hong K, China.Manufacturer Firm 2: Technic Star Products Factory, Buji Shenzhen, China. Firm initiated recall is ongoing.
REASON: Gel filled teethers were found to contain Bacillus circulans and Bacillus subtilis.

PRODUCT: Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200, Recall # Z-1955-2009
MANUFACTURER: Recalling Firm: Draeger Medical Systems, Inc, Telford, PA, by press release and letter on July 20, 2009. Manufacturer: Hill-Rom, Inc, Batesville, IN. Firm initiated recall is ongoing.
REASON: Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete.

CLASS II
PRODUCT: Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only, Recall # Z-1693-2009
MANUFACTURER: Draeger Medical Systems, Inc., Telford, PA, by letter on August 7, 2009. Firm initiated recall is ongoing.
REASON: Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly.

PRODUCT: Amvex Integrated Flowmeter; a nonback-pressure compensated Bourdon gauge flowmeter; Amvex Corporation, 25B East Pearce St, Richmond Hill, Ontario L4B 2M9, Canada; Model No. FI. The Integrated Flowmeter has two parts, the Outlet port and the Flowmeter port. The Outlet port is intended to be used as a standard wall Outlet, delivering a high flow of gas to secondary equipment. The Flowmeter port is intended to deliver a fixed flow of gas to patient or equipment, Recall # Z-1724-2009
MANUFACTURER: Amevex Corporation, Richmond Hill, Canada, by letter dated May 29, 2009. Firm initiated recall is ongoing.
REASON: The affected flowmeters may have a damaged o-ring which may cause the flowmeter to deliver higher amounts of gas and or not be able to shut off fully.

PRODUCT: Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45 Cuvettes; For Performance on the HEMOCHROM Whole Blood Microagulation Systems; The HEMOCHRON Jr. ACT-LR is a quantitative assay for monitoring heparin anticoagulation during various medical procedures. The ACT-LR demonstrated linear correlation to the anticoagulation effects of heparin up to 2.5 unit/ml of blood. It is intended for use in monitoring low to moderate heparin doses frequently associated with procedures such as cardiac catheterization, Extracorporeal Membrane Oxygenation (ECMO) Hemodialysis, and Percutaneous Transluminal Coronary Angioplasty, Recall # Z-1732-2009
MANUFACTURER: International Technidyne Corp., Edison, NJ, by letter dated May 4, 2009. Firm initiated recall is ongoing.
REASON: One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria.

PRODUCT: 1) LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile. The device is used for Orthopedic Knee Implants, Recall # Z-1819-2009; 2) LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile. The device is used for Orthopedic Knee Implants, Recall # Z-1820-2009
MANUFACTURER: Smith & Nephew Inc., Memphis, TN, by letter on January 22, 2009. Firm initiated recall is ongoing.
REASON: Products were mispackaged.

PRODUCT:
1) Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, a) Models N118 and b) N119. Sterilized using ethylene oxide. The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing, Recall # Z-1932-2009;
2) Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, a) Models E102 and b) E110. Sterilized using ethylene oxide. The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing, Recall # Z-1933-2009
MANUFACTURER: Recalling Firm: Boston Scientific CRM Corp., Saint Paul, MN, by visit beginning July 17, 2009 and by letters dated July 17, 2009 and July 22, 2009.
Manufacturer: Guidant Ireland, Clomel, County Tipperary, Ireland. Firm initiated recall is complete.
REASON: Boston Scientific Cardiac Rhythm Management retrieved devices that could be subject to a potential for acute non-secure lead connections when implanted. Nonsecure lead connections can manifest as high impedance, or lead electrogram artifacts resulting in oversensing and/or inappropriate delivery of therapy.

PRODUCT:
1) Medtronic Virtuoso DR, Model D154AWG, Dual Chamber implantable cardioverter defibrillator with atrial and ventricular therapies. This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure. In addition, the device is indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias, Recall # Z-1953-2009;
2) Medtronic Virtuoso VR, Model D154VWC, Single Chamber implantable cardioverter defibrillator with atrial therapies. This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure, Recall # Z-1954-2009
MANUFACTURER: Recalling Firm: Medtronic, Inc., Cardiac Rhythm Management, Mounds View, MN, by visit on July 27, 2009. Manufacturer: Medtronic Puerto Rico Operations Company, Juncos, PR. Firm initiated recall is complete.
REASON: Medtronic has detected a specific pattern of MOSFET IC malfunctions in its Concerto, Virtuoso and EnRhythm family of devices. The probability of occurrence decreases with time and, to date over 90% of the malfunctions related to the pattern have occurred within the first twelve months after implant.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Sept 2, 2009:

CLASS II
PRODUCT: Bausch & Lomb, Boston Conditioning Solution, Original Formula, For Rigid Gas Permeable Contact Lenses, 1 fl. oz. (30 ml), Recall # Z-1735-2009
MANUFACTURER: Recalling Firm: Bausch & Lomb, Inc., Rochester, NY, by letter dated June 26, 2009. Manufacturer: Bausch & Lomb, Inc., Greenville, SC. Firm initiated recall is ongoing.
REASON: The product failed to meet one of the shelf life specifications at the end of the expiry period.

PRODUCT:
1) Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF 7961810; 12MM, REF 7961812; 14MM, REF 7961814; 16MM, REF 7961816; 18MM, REF 7961818; 20MM, REF 7961820; Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1796-2009;
2) Medtronic INTREPID Spinal System SPACER, 32X23, 12 DEG, Size: 10MM, Part Number: REF 7961210; 12MM, REF 7961212; 14MM, REF 7961214; 16MM, REF 7961216; 18MM, REF 7961218; 20MM, REF 7961220; Rx only, STERILE R The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1797-2009;
3) Medtronic INTREPID Spinal System SPACER M 37X27, 8 DEG, Size 10MM, Part Number: REF 7962810; 12MM, REF 7962812; 14MM, REF 7962814; 16MM, REF 7962816; 18MM, REF 7962818; 20MM, REF 7962820; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1798-2009;
4) Medtronic INTREPID Spinal System SPACER M 37X27, 12 DEG, Size: 10MM, Part Number: REF 7962210; 12MM, REF 7962212; 14MM, REF 7962214; 16MM, REF 7962216; 18MM, REF 7962218; 20MM, REF 7962220; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1799-2009;
5) Medtronic INTREPID Spinal System SPACER L 42X30, 8 DEG, Size: 10MM: Part Number: REF 7963810; 12MM, REF 7963812; 14MM, REF 7963814; 16MM, REF 7963816; 18MM, REF 7963818; 20MM, REF 7963820; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1800-2009;
6) Medtronic INTREPID Spinal System SPACER L 42X30, 12 DEG, Size: 10MM, Part Number: REF 7963210; 12MM, REF 7963212, 14MM, REF 7963214; 16MM, REF 7963216; 18MM, REF 7963218; 20MM, REF 7963220; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1801-200;
7) Medtronic INTREPID Spinal System Coverplate, size: Small, Part Number: REF 7961330; medium, REF 7962330; large, REF 7963330; STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1802-2009;
8) Medtronic SOFAMOR DANEK INTREPID SPINAL SYSTEM, 5.5MM TAPERED SCREW, Length: 20MM, , Part Number: REF 7960020; 25MM, REF 7960025, 30MM, REF 7960030; and 35MM, REF 7960035; QTY: 1 EA, NON-STERILE, Rx only. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1803-2009
MANUFACTURER: Medtronic Sofamor Danek USA Inc, Memphis, TN, by telephone beginning February 6, 2009 and by letter dated April 2009. Manufacturer: Medtronic Sofamor Danek Deggendorf GmbH, Deggendorf, Bavaria, Germany. Firm initiated recall is ongoing.
REASON: The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.

PRODUCT: BD 60ml Syringe Luer-Lok tip, Sterile, Product Number: 309653, Recall # Z-1811-2009
MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letter dated July 7, 2009. Manufacturer: Becton Dickinson & Company, Columbus, NB. Firm initiated recall is ongoing.
REASON: Insufficient Seal

PRODUCT: Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456, Recall # Z-1813-2009
MANUFACTURER: Respironics California, Inc, Carlsbad, CA, by letter dated April 22, 2009. Firm initiated recall is ongoing.
REASON: The recall was initiated because through routine product monitoring Respironics discovered that under certain conditions, when operating on AC line power, a portion of the current from the External Battery charger is erroneously diverted to the ventilator. When this occurs, the External Battery charger may not transition correctly. Prolonged operation in this condition results in overcharging and accelerated aging of the battery cells. Using batteries beyond their useful life may lead to a ventilator restart and Vent Inop condition. Should a Vent Inop condition occur the ventilator will alarm both audibly and visually, and will cease to operate creating the potential for patient injury.

PRODUCT:
1) Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, Software versions v2.1 & v3.0, Recall # Z-1815-2009;
2) Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, Software versions v2.1 & v3.0, Recall # Z-1816-2009
MANUFACTURER: Hospira, Inc., Morgan Hill, CA, by letter dated March 31, 2009. Firm initiated recall is ongoing.
REASON: Potential delay/under infusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage.

PRODUCT: Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Recall # Z-1934-2009
MANUFACTURER: Edwards Lifesciences AG, Haina, San Cristobal, Dominican Republic, by letter dated March 10, 2008. Firm initiated recall is complete.
REASON: Edwards Lifescience initiated a recall of on Edwards "VAMP Jr" Pressure Monitoring Products manufactured between 8/01/06 and 2/29/08 due to the potential for the cap on the reservoir of the "VAMP Jr" to become disconnected.

PRODUCT: 1) Stryker Reflex Hybrid Level Anterior Cervical Plate; Non Sterile; Catalog Number/Description: 48650112, Reflex Hybrid one-level plate, size 12mm; 48650114m size 14 mm; 48650116, 16 mm; 48650118, size 18mm; 48650120, size 20 mm; 48650122, size 22 mm. 48650224, Reflex Hybrid Two-Level Plate, size 24 mm; 48650226, size 26 mm; 48650228, size 28 mm; 48650230, size 30 mm; 48650232, size 32 mm; 48650234, size 34 mm; 48650237, size 37 mm; 48650240, size 40 mm; 48650243, size 43 mm; 48650246, size 46 mm. 48650339, Reflex Hybrid Three-Level Plate, Size 39 mm; 48650342, size 42mm; 48650345, suze 45 mm; 48650348, size 48 mm; 48650351, size 51 mm; 48650354, size 54 mm; 48650357, size 57 mm; 48650360, size 60 mm; 48650363, size 63 mm; 48650366, size 66 mm; 48650369, size 69 mm. 48650460, Reflex Hybrid four-Level Plate, size 60 mm; 48650464, size 64 mm; 48650468, size 68 mm; 48650472, size 72 mm; 48650476, size 76 mm; 48650489, size 80 mm; 48650484, size 84 mm, Recall # Z-1958-2009;
2) Stryker Reflex Hybrid variable self-drilling screw. Non Sterile. All Product with the following Catalog Number/ Description: 48664010, Variable Angle Bone Screw Self Drilling, Diameter 4.0 x 10 mm; 48664012, diameter 4.0 x 12 mm; 48604014, diameter 4.0 x 14 mm; 48664016, diameter 4.0 x 16 mm; 48664018, diameter 4.0 x 18 mm, Z-1959-2009;
3) Stryker Reflex Hybrid Variable Self-Tapping Screw. Non Sterile. Catalog Number/Description: 48684012, Variable Angle Bone Screw, diameter 4.0 x 10 mm; 48684012, diameter 4.0 x 12 mm; 48684014, diameter 4.0 x 14 mm; 48684018, diameter 4.0 x 18 mm; 48684020, diameter 4.0 x 20 mm; 48684512, diameter 4.5 x 12 mm; 48684516, diameter 4.5 x 14 mm; 48684516, diameter 4.5 x 16 mm; 48684518, diameter 4.5 x 18 mm; 48684520, diameter 4.5 x 20 mm, Recall # Z-1960-2009
MANUFACTURER: Stryker Spine, Allendale, NJ, by letter dated June 14, 2009.
Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is complete.
REASON: Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.
Please visit our websites at www.mdiconsultants.com for more information on mdi’s services, staff and items of interest.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 26, 2009:

CLASS I

PRODUCT:
1) The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) with software version 4 and above, Recall # Z-1790-2009;
2) The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version 8 and above when used with the Alaris PCA Module (Model 8120). The Alaris PC Unit is the central programming and power supply component for the Alaris System modules, Recall # Z-1791-2009;
3) The Alaris PC Unit, Model 8015 (manufactured or serviced between April 2008 and January 2009). The Alaris PC Unit is the central programming and power supply component for the Alaris System modules, Recall # Z-1792-2009;
4) Alaris Pump Module, Model 8100, Recall # Z-1793-2009;
5) Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Alaris PC Unit, Model Numbers 8000 and 8015; Alaris Pump Module, Model 8100; Alaris Patient-Controlled Analgesia (PCA), Model 8120; Alaris Syringe Module, Model 8110; Alaris SpO2 Module, Model 8210 and 8220 and Alaris EtCO2 Module, Model 8300, Recall # Z-1794-2009
MANUFACTURER: Recalling Firm: Cardinal Health 303 dba Cardinal Health, San Diego, CA, by letters on June 12, 2009. Manufacturer: Cardinal Health Manufacturing LLC, San Diego, CA. Firm initiated recall is ongoing.
REASON: There is a potential risk for medication not being delivered when IV tubing sets are occluded in the Alaris Pump module. This can occur if IV sets are set up in the infusion pumps but not used for an extended period of time. If users fail to clear the occlusion, then the occluded tubing may cause medication not to be delivered. A delay of medication may result in serious injury and/or death, and may necessitate medical intervention to prevent serious injury and/or death.

CLASS II

PRODUCT:
1) Roche ACCU-CHEK Softclix Lancing Device, Models 3144844001 (10 lancets) and 3583031002 (17 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing, Recall # Z-1590-2009;
2) Roche ACCU-Chek Active Meter Kit; REF 03184501001 includes the Roche ACCU-CHEK Softclix Lancing Device, Model 3144844001 (10 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing, Recall # Z-1591-2009;
3) Roche ACCU-Chek Voicemate Meter; REF 12030802001 includes the Roche ACCU-CHEK Softclix Lancing Device, Model 3144844001 (10 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing, Recall # Z-1592-2009;
4) Roche ACCU-Chek Aviva Meter Kit; REF 04893247001 includes the Roche ACCU-CHEK Softclix Lancing Device, Model 3144844001 (10 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing, Recall # Z-1593-2009;
5) Roche Coaguchex XS Systems for Patient Self-Testing; REF 04837738001 includes the Roche ACCU-CHEK Softclix Lancing Device, Model 3144844001 (10 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing, Recall # Z-1594-2009;
6) Roche ACCU-CHEK Compact Plus Meter Kit; REFS 03149137001, 05177294001 and 05079241001 include the Roche ACCU-CHEK Softclix Lancing Device, Model 3583031002 (17 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing, Recall # Z-1595-2009
MANUFACTURER: Roche Diagnostics Corp., Indianapolis IN, by letter dated May 13, 2009, and by press release on May 18, 2009. Firm initiated recall is ongoing.
REASON: The lancet cap may be missing, which could result in an unintended lancet stick to the user.

PRODUCT:
1) Exogen 4000+ Ultrasound Bone Healing System, SAFHS, Part Numbers: a) 71034100 and b) 71034101, Rx only, The device is used for the non-invasive treatment of established non-unions excluding skull and vertebra, Recall # Z-1695-2009;
2) Exogen Express Bone Healing System, SAFHS, Part Numbers: a) 71034200 and b) 71034140, Rx only. These are distributed internationally only. The device is used for the non-invasive treatment of established nonunions excluding skull and vertebra, Recall # Z-1696-2009
MANUFACTURER: Recalling Firm: Smith & Nephew Inc., Memphis, TN, by letters dated June 5, 2009 and June 8, 2009. Manufacturer: Morgan Electro Ceramics, Bedford, OH. Firm initiated recall is ongoing.
REASON: Problems with transducer may result in a reduced ultrasound output.

PRODUCT: Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths 30mm-55mm, labeled non-sterile. The Capless LI Pedicle Screw System is indicated for the treatment of sever spondylolisthesis of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, Recall # Z-1694-2009
MANUFACTURER: X Spine Systems Inc., Miamisburg, OH, by letters, telephone and e-mails in March 2009. Firm initiated recall is ongoing.
REASON: A defect cause was discovered following a customer complaint pertaining to a post operative dissociation of the Capless Li Screw construct. The screw assembly is made up of three parts; a cup which locks onto a 5.5mm rod, a yoke that cradles the rod during fusion, and a screw that attached to the vertebra. The screw ball on the screw was manufactured out of tolerance (undersized).

PRODUCT: Foot Choice Therapeutic Foot Massager, Model Number YS-322. The device is a heated foot massager intended for over the counter use, Recall # Z-1697-2009
MANUFACTURER: Recalling Firm: Suarez Corporation Industries, Canton, OH, by letter on August 9 –August 14, 2006. Manufacturer: Yas Healthy Fitness Co., Ltd., Taoyuan City, Taiwan. Firm initiated recall is ongoing.
REASON: Complaints of product causing burns to consumers.

PRODUCT:
1) SJM Peel Away Introducer, REF 405116, Length 14 cm, 9F (3.00 mm), Max Guidewire o.d 0,38" (.965 mm), contents 5, 2011-08, Sterile EO, Rx only. Intended for use for the introduction of catheters into a vessel, Recall # Z-1713-2009;
2) SJM Peel Away Introducer, REF 405153, Length 14 cm, 7F (2.33 mm), Max Guidewire o.d 0,38" (.965 mm), contents 5, 2011-08, Sterile EO, Rx only. Intended for use for the introduction of catheters into a vessel, Recall # Z-1714-2009
MANUFACTURER: St. Jude Medical, Minnetonka, MN, by letter in June 2009. Firm initiated recall is ongoing.
REASON: Isolated lots could contain some items that have been mislabeled with the incorrect French size of the outer box label. Some 9F products have been labeled as 7F and vice versa. Only the outer box label is affected by this error, the labels on the individual product pouches correctly identify the product. St Jude Medical has not received any reports of injures resulting from this mislabeling to date.

PRODUCT: M-19 (Iridium 192): Brachytherapy source, Recall # Z-1717-2009
MANUFACTURER: Source Production & Equipment, Inc., St Rose, LA, by telephone and letter in March 2008. Firm initiated recall is complete.
REASON: Radioactive source broke during use.

PRODUCT: AdvantageSim MD versions 7.4 through 7.6, Model 5160092. AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning, Recall # Z-1718-2009
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated March 11, 2009. Manufacturer: GE Medical Systems, SCSBuc Cedex, France. Firm initiated recall is ongoing.
REASON: It was reported by a customer site that when using Advantage Sim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.

PRODUCT: GE Healthcare MUSE Cardiology Information Systems vs. 7.0, 7.0.1, 7.0.2, 7.1, 7.1.1. The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients, Recall # Z-1719-2009
MANUFACTURER: Recalling Firm: GE Healthcare, Wauwatosa, WI, by letter dated October 13, 2008. Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.
REASON: GE Healthcare has become aware of an issue resulting from a workflow situation related to the automated labeling of patient data in the MUSE Cardiology Information System. When a prior record has been confirmed with an invalid (default) patient identifier (PID), MUSE will accept future records with the same default PID as correct. If subsequent records don not contain a name, MUSE will pre-populate the Name field with the same name associated with the initially confirmed record. This will lead to incorrect information contained in stored and printed records.

PRODUCT: GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles. Image analysis software package that allows the user to produce image data and to generate information with regard to changes in image intensity over time supporting CT Perfusion images, Recall # Z-1720-2009
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated October 23, 2009. Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON: GE Healthcare has recently become aware of the need to adjust default settings associated with the use of CT Perfusion 4 on the Advantage Workstation, ST and PET/CT consoles that may impact patient safety. The default parameter settings in CT Perfusion 4 may not be optimal in the case of data acquired with longer time sampling intervals such as axial scans with inter scan delay (ISD) greater than 2 seconds of Volume Shuttle date. This can result in reduced conspicuity of subtle perfusion defects due to increased noise in these types of data sets.

PRODUCT:
GE Healthcare, Drapes and Sterile Covers PART NUMBER DESCRIPTION 00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL 00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AND HOSE 2000,2500 00-900352-02 STRL, BAG, DRAIN WITH METAL TABS 00-900493-03 COVER DISPOSABLE X-RAY TUBE 00-900605-01 UROFAST DRAIN BAG (UROFAST ONLY) 00-900605-01-OEC STRL, BAG, DRAIN, WITH HOSE, UROFAST 00-900885-01 URO2600 DRAIN BAG 2.0 PE MATERIAL 00-900885-01-OEC STRL, BAG, DRAIN, URO2600 00-900943-01 STRL, COVER, CARM, HALF BAG, 36X80, 90,94,76 00-900974-01 STRL, DRAPING, MINI-CARM, KYBRD, BLK FTSW, 6600 00-901072-01 URO 2600 DISPOSABLES PACK 2.0 PE MATERIAL 00-901072-01-OEC STRL, PACK, DISPOSABLES, UROVIEW 2600 00-901169-01 12 TUBE DRAPE (36X36) 2.0 PE MATERIAL 00-901169-01-OEC STRL, COVER, DISPOSABLE, 12 INCH TUBE 9600 00-901268-01 DRAPE,STERIQUIK, STANDARD&SUPER- C,9600/7700 00-901390-01 STRL, DRAPING, KEYBOARD, FOOTSWITCH, 20PACK, 6600 00-901391-01 STRL, DRAPE, C-ARM ONLY, 6600 00-901392-01 STRL, COVER, KEYBOARD, 66,68 00-901501-01 9600/9800/SUPER C DISPOSABLES PACK 2.0 PE MATERIAL 00-901501-01-OEC STRL, PACK, DISPOSABLES, MODEL 9800, 20 PACK 00-901581-01-OEC STRL, COVER, DISPOSABLE, IR REMOTE, 9600, 9800 00901588-01 12 C ARM DISPOSABLES PACK 2.0 PE MATERIAL 00-901588-01-OEC STRL, PACK, DISPOSABLES, 12 INCH, 20 PACK SCD 9600 00-901761-01 STRL, DISPOSABLES PACK, UROVIEW 2800 00-901831-02 STRL, COVER, FLUOROTRAK MONITOR, DISPOSABLE BOX 10 PER PKG 00-901832-01 STRL, APIX, COVER, DISPOSABLE CONTROLPANEL COVERS, REPLACEMENT PART CASE OF 25 00-901917-01 STRL, DRAPE, C-ARM, 6800 00-901918-01 MINIVIEW 6800 C-ARM CONSUMABLES PACK GRAY FOOTSWITCH 00-901918-01-OEC STRL, DRAPE, 20 PACK, 6800 00-902752-01 STRL, RUI COVERS 25 COVERS 00-902753-01 STRL, PACK, DISPOSABLE, 9800MD, 9 INCH 20 PACKS 00-902754-01 STRL, PACK, DISPOSABLE, 9800MD, 12 INCH 20 PACKS 00-902776-01 STRL, DRAPE, VASCULAR 00-902864-01 STRL, DRAPE, HALF, C ARM, 9800 9600 00-902934-01 STRL, DRAPE, WORKSTATION, 20 PER BOX, 9900 1003135 STRL, BAG, FLAT PANEL E7009AE STRL, DRAPE, AFM/CFM PEDESTAL, 25 PER BOX E7009AF STRL, DRAPE, AFM/CFM JOYSTICK, 50 PER BOX E7009AG STRL, DRAPE, LARGE DOME BAG, 20 PER BOX E7009AH STRL, DRAPE, MEDIUM DOME BAG, 20 PER BOX E7009AJ STRL, DRAPE, SMALL DOME BAG, 20 PER BOX Sterile EO. The disposable sterile product provide a sterile barrier between the imaging device and sterile surgical field, Recall # Z-1730-2009
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated August 15, 2008. Manufacturer: Contour Fabricators, Inc., Fenton, MI. Firm initiated recall is ongoing.
REASON: GE Healthcare has found that the sterile products may have sterile seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state.

PRODUCT: Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the Dimension Clinical Chemistry System with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk of stratification of patients with acute coronary syndromes with respect to their relative risk of mortality, Recall # Z-1731-2009
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter on April 8, 2008. Firm initiated recall is complete.
REASON: Possibility of falsely elevated results.

PRODUCT: CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater, Recall # Z-1734-2009
MANUFACTURER: Veridex, LLC, Raritan, NJ, by letter dated March 12, 2009. Firm initiated recall is ongoing.
REASON: Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 19, 2009:

CLASS II
PRODUCT:
1) Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8512, Size 6, 4 boxes of 50, Sterile. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs, Recall # Z-1583-2009;
2) Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8513, Size 6 1/2, 4 boxes of 50, Sterile. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs, Recall # Z-1584-2009;
3) Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8514, Size 7, 4 boxes of 50, Sterile. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs, Recall # Z-1585-2009;
4) Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8515, Size 7 1/2, 4 boxes of 50, Sterile. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs, Recall # Z-1586-2009;
5) Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8516, Size 8, 4 boxes of 50, Sterile. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs, Recall # Z-1587-2009;
6) Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8517, Size 8 1/2, 4 boxes of 50, Sterile. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs, Recall # Z-1588-2009;
7) Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8518, Size 9, 4 boxes of 50, Sterile. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs, Recall # Z-1589-2009
MANUFACTURER: Recalling Firm: Ansell Healthcare Products LLC, Dothan AL, by letters on May 1, 2009 and May 4, 2009. Manufacturer: Ansell Lanka (Pvt), Ltd., Biyagama (Columbo), Sri Lanka. Firm initiated recall is ongoing.
REASON: Premature degradation which could result in tearing during use.

PRODUCT: Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silicone Tip, for human use with insulin pen injector device to administer insulin subcutaneously, Recall # Z-1596-2009
MANUFACTURER: Stat Medical Devices, Inc., Miami, FL, by letter dated June 18, 2009. Firm initiated recall is ongoing.
REASON: Stat Pen Needles with silicone coating have not been cleared by FDA for use with silicone coating which could significantly affect the safety and effectiveness of the device.

PRODUCT:
1) Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile; Cat. no./REF 6647, a) inner pouch UPN M00566470 and b) outer carton UPN M00566471. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means, Recall # Z-1625-2009;
2) Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile; Cat. no./REF 6649, a) inner pouch UPN M00566490 and b) outer carton UPN M00566491. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means, Recall # Z-1626-2009;
3) Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile; Cat. no./REF 6653, a) inner pouch UPN M00566530 and b) outer carton UPN M00566531. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means, Recall # Z-1627-2009;
4) Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, for use with pre-filled lidocaine syringe, latex free, sterile; Cat. no./REF 6673, a) inner pouch UPN M00566730 and b) outer carton UPN M00566731. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means, Recall # Z-1628-2009;
5) Boston Scientific EndoVive 20Fr (8 mm) Safety PEG Kit, Push Method, for use with pre-filled lidocaine syringe, latex free, sterile; Cat. no./REF 6675, a) inner pouch UPN M00566750 and b) outer carton UPN M00566751. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means, Recall # Z-1629-2009;
6) Boston Scientific EndoVive 20F (6.7 mm) Standard PEG Kit, Push Method, latex free, sterile; Cat. no./REF 6821, inner pouch UPN M00568210 and outer carton UPN M00568211. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means, Recall # Z-1630-2009;
7) Boston Scientific EndoVive 24F (8 mm) Standard PEG Kit, Push Method, latex free, sterile; inner pouch UPN M00568250 and outer carton UPN M00568251. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means, Recall # Z-1631-2009;
8) Boston Scientific EndoVive 20F (6.7 mm) Standard PEG Kit, latex free, sterile; Cat. no./REF 6840, inner pouch UPN M00568400 and outer carton UPN M00568401. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means, Recall # Z-1632-2009.
MANUFACTURER: Boston Scientific, Corp., Spencer, IN, by letter dated May 5, 2009. Firm initiated recall is ongoing.
REASON: The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.

PRODUCT:
1) Passive Clip Slings; washable sling; these slings are intended for use with ARJO and BHM Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with clip slings. The slings are used to assist with the lifting and transportation of a patient in the horizontal or other required position from one place to another and used only by appropriately trained caregivers. Models MAA2XXX, MAA4XXX and MAA7XXX, Recall # Z-1636-2009;
2) Flite Clip Slings; patient specific disposable sling; these slings are intended for use with Arjo and BHM Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with clip slings. The slings are used to assist with the lifting and transportation of a patient in the horizontal or other required position from one place to another and used only by appropriately trained caregivers. Model MFA1000M, Recall # Z-1637-2009
MANUFACTURER: Recalling Firm: ArjoHuntleigh, Addison, IL, by letter dated January 30, 2009. Manufacturer: Medibo N.V., Hamont, Achel, Belgium. Firm initiated recall is ongoing.
REASON: If the sling clips are not applied or are applied incorrectly, there is the potential for the patient to fall, resulting in injury to both the patient and/or the caregiver.

PRODUCT: DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine. Recall # Z-1670-2009
MANUFACTURER: Recalling Firm: DePuy Spine Inc., Raynham, MA, by visit and by letter beginning February 11, 2009. Manufacturer: Norwood Tool Co, Dayton, OH. Firm initiated recall is ongoing.
REASON: Tip of Driver may break during use.

PRODUCT: 1) 12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers a) AK-12123-H, b) CS-12123-E, c) MA-12123, and d) MC-12123. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins, Recall # Z-1671-2009. 2) 12 French 3 Lumen 20 cm Large-Bore Central Venous Catheters. Product numbers a) AK-15123-H, b) AK-15123-J, c) CS-15123-E, and d) MC-15123. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins, Recall # Z-1672-2009
MANUFACTURER: Arrow International, Inc., Reading, PA, by letter dated May 11, 2009. Firm initiated recall is ongoing.
REASON: Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.

PRODUCT: Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator, Recall # Z-1674-2009
MANUFACTURER: Recalling Firm: Essential Medical Supply, Inc., Orlando, FL, by letters on April 30, 2009 and May 8, 2009. Manufacturer: Jia Shan Kanglida Physical Therapy Equip. Co., LTD, Jiashan, Zhejiang Provi, China. Firm initiated recall is ongoing.
REASON: The caster may separate from the frame completely causing injury to the user.

PRODUCT:
1) Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. Part 8717741, Recall # Z-1676-2009;
2) Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. a) Part 10275007, b) part 10275008, c) part 10275009, d) part 10275010, Recall # Z-1677-2009.
MANUFACTURER: Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters dated April 22, 2009. Firm initiated recall is ongoing.
REASON: The pinion gear could crack and cause the gantry to spin freely thereby damaging the Symbia S or T System and potentially injuring a patient during a scan.

PRODUCT: Trident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated, Multi holed; Sterile; Stryker, France. Single use devices intended for cementless fixation within the prepared acetabulum. Intended for use with the mating Trident Polyethylen Cup Inserts; Product Number: 508-11-72J, Recall # Z-1685-2009
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated May 29, 2007. Firm initiated recall is complete.
REASON: Stryker Orthopedics became aware that Trident Hemispherical Shells, Catalog Number 508-11-74J, are actually marked and labeled as Catalog Number 598-11-72J, Lot Code 20282301.

PRODUCT: Prolieve Thermo dilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH (Benign Prostatic Hyperplasia) Thermotherapy, Material Numbers: a) M0068808022 and b) M0068808170, Recall # Z-1692-2009
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Marlborough MA, by letter on July 20, 2009. Manufacturer: Accellent Juarez, Juarez, Mexico. Firm initiated recall is ongoing.
REASON: Balloon leaks: Boston Scientific has received complaints from the field involving product leaks associated with the anchor balloons and compression balloons. Correspondence between BSC and FDA has led to BSC's decision to remove the Prolieve Catheter Kits from the field.

PRODUCT: 1) Zimmer ITST Intertrochanteric/subtrochanteric fixation tapered reamer, nonsterile; REF 2258-50-00, Recall # Z-1701-2009;
2) Zimmer ITST Intertrochanteric/subtrochanteric fixation taper reamer - Asia, nonsterile; REF 2258-50-01. (Note: This product is not distributed in the United States), Recall # Z-1702-2009
MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letter dated June 5, 2009. Firm initiated recall is ongoing.
REASON: Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa.

PRODUCT: Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55, Recall # Z-1703-2009
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters dated June 9, 2009. Firm initiated recall is complete.
REASON: The Surgical Protocol has been modified to create separate and distinct surgical protocols, one for the Trident PSL Shell (LSP68) and one for the Trident Hemispherical Shell (LSP69) in order to clarify and highlight the differences in reaming technique.

PRODUCT: IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery, Recall # Z-1704-2009
MANUFACTURER: Smith & Nephew, Inc., Memphis, TN, by e-mail on January 22, 2009 and by letter dated January 23, 2009. Firm initiated recall is ongoing.
REASON: Incorrect depth gauge mark etched onto guide wire pin. Guide pin is too long.

CLASS III
PRODUCT: Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. Solid Medium recommended for use in qualitative procedures for the isolation and cultivation of mycobacteria, Recall # Z-1733-2009
MANUFACTURER: Remel, Inc., Lenexa, KS, by letters dated May 6, 2008. Firm initiated recall is complete.
REASON: The plate labeling is incorrect, but the outer box labeling is correct.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 12, 2009:

CLASS I

PRODUCT:
1) POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US) Part #1005524-18, Recall # Z-1804-2009;
2) POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08, Recall # Z-1805-2009;
3) POWERSAIL Coronary Dilatation Catheter: 2.75x18mm (US) Part #1005522-18, Recall # Z-1806-2009;
4) POWERSAIL Coronary Dilatation Catheter: 3.25x8mm (US) Part #1005524-08, Recall # Z-1807-2009
MANUFACTURER: Abbott Vascular-Cardiac Therapies dba Guidant Corp., Temecula, CA, by letter on June 17, 2009 and press release dated July 28, 2009. Firm initiated recall is ongoing.
REASON: Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.

CLASS II

PRODUCT:
1) Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 degree neck angle. Accolade 132 Size 1, Item Number: 6020-0130.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous
total hip arthroplasty, Recall # Z-1354-2009; 2) Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40
Taper, Sterile. 132 degree neck angle. Item Number: 6020-0230 ACCOLADE 132 SIZE
2. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous
total hip arthroplasty. Recall # Z-1355-2009;
3) Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 degree neck angle. Item # 6020-0335 ACCOLADE 132 SIZE 3. Hip
stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip
arthroplasty, Recall # Z-1356-2009;
4) Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 degree neck angle. Item Number: 6020-0335, ACCOLADE 132 SIZE
3. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous
total hip arthroplasty, Recall # Z-1357-2009;
5) Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 degree neck angle. Item Number: 6020-0537 ACCOLADE 132 SIZE
5. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous
total hip arthroplasty, Recall # Z-1358-2009;
6) Sterile. 132 degree neck angle. Item Number: 6020-0637 ACCOLADE 132 SIZE 6. Hip stems are single use devices intended for cementless fixation. The products are
intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium
Plasma Spray, V40 Taper, Recall # Z-1359-2009;
7) Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 degree neck angle. Item #: 6020-0740 ACCOLADE 132 SIZE 7. Hip
stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip
arthroplasty, Recall # Z-1360-2009;
8) Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 degree neck angle. Item #: 6020-2530 ACCOLADE 132 SIZE 2.5.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous
total hip arthroplasty, Recall # Z-1361-2009;
9) Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 degree neck angle. Item # 6020-3535 ACCOLADE 132 SIZE 3.5. Hip
stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip
arthroplasty, Recall # Z-1362-2009;
10) Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 degree neck angle. Item #: 6020-4535 ACCOLADE 132 SIZE 4.5.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous
total hip arthroplasty, Recall # Z-1363-2009;
11) Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree
neck angle. Item #: 6021-0230 ACCOLADE (127 DEG) SIZE 2. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary
reconstruction of the proximal femur or revision of a previous total hip arthroplasty. Recall # Z-1364-2009;
12) Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree
neck angle. Item #: 6021-0335 ACCOLADE (127 DEG) SIZE 3. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary
reconstruction of the proximal femur or revision of a previous total hip arthroplasty, Recall # Z-1365-2009;
13) Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree
neck angle. Item #: 6021-0435 ACCOLADE (127 DEG) SIZE 4. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary
reconstruction of the proximal femur or revision of a previous total hip arthroplasty, Recall # Z-1366-2009;
14) Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree
neck angle. Item #: 6021-0537 ACCOLADE (127 DEG) SIZE 5. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary
reconstruction of the proximal femur or revision of a previous total hip arthroplasty, Recall # Z-1367-2009;
15) Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree
neck angle. Item #: 6021-0637 ACCOLADE (127 DEG) SIZE 6. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary
reconstruction of the proximal femur or revision of a previous total hip arthroplasty. Recall # Z-1368-2009;
16) Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree
neck angle. Item Number: 6021-0740 ACCOLADE PLUS TMZF HIP STEM #7. Hip stems are single use devices intended for cementless fixation. The products are intended
for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty, Recall # Z-1369-2009;
17) Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree
neck angle. Item #: 6021-2530 ACCOLADE (127 DEG) SIZE 2.5. Hip stems are single use devices intended for cementless fixation. The products are intended for use in
primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty, Recall # Z-1370-2009;
18) Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray;
V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle. Hip stems are single use devices intended for cementless fixation. The
products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. Item #: 6021-3535 ACCOLADE (127 DEG) SIZE
3.5, Recall # Z-1371-2009;
19) Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree
neck angle. Item #’s: 6021-4535 ACCOLADE (127 DEG) SIZE 4.5, Recall # Z-1372-2009;
20) Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree
neck angle. Item # 6021-5537 ACCOLADE (127 DEG) SIZE 5.5. Hip stems are single use devices intended for cementless fixation. The products are intended for use in
primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. Recall # Z-1373-2009;
21) Citation TMZF HA Hip Stem. Item #’s: 6265-5103 CITATION TMZF SIZE 3 LEFT. Hip stems are single use devices intended for cementless fixation. The products
are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty, Recall # Z-1374-2009;
22) Citation TMZF HA Hip Stem. Item #’s: 6265-5105 CITATION TMZF SIZE 5 LEFT. Hip stems are single use devices intended for cementless fixation. The products
are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty, Recall # Z-1375-2009;
23) Citation TMZF HA Hip Stem. 6265-5106 CITATION TMZF SIZE 6 LEFT. Hip stems are single use devices intended for cementless fixation. The products are intended
for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. Recall # Z-1376-2009;
24) Citation TMZF HA Hip Stem - RT. Item #: 6265-5112 CITATION TMZF SIZE 2 RIGHT. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a
previous total hip arthroplasty. Recall # Z-1377-2009;
25) Citation TMZF HA Hip Stem - RT. Item #: 6265-5113 CITATION TMZF SIZE 3 RIGHT. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty, Recall # Z-1378-2009;
26) Citation TMZF HA Hip Stem - RT. Item #: 6265-5114 CITATION TMZF SIZE 4 RIGHT. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. Recall # Z-1379-2009;
27) Citation TMZF HA Hip Stem - RT. Item #: 6265-5115 CITATION TMZF SIZE 5 RIGHT. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a
previous total hip arthroplasty, Recall # Z-1380-2009;
28) Citation TMZF HA Hip Stem. Item # 6265-5116 CITATION TMZF SIZE 6 RIGHT. Hip stems are single use devices intended for cementless fixation. The products are
intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. Recall # Z-1381-2009;
29) Short Citation TMZF HA Hip Stem - Right; Hydroxylapatite Coated, Titanium Plasma Spray; V40 Taper, 132 degree neck angle: Stem Length - 102mm; Head Offset -
52mm, Distal Diameter - 16mm. Item #: 6265-5217 Citation TMZF HA Short Size#7R. Hip stems are single use devices intended for cementless fixation. The products are
intended for use in primary reconstruction of the proximal femur or revision of a previous
total hip arthroplasty, Recall # Z-1382-2009;
30) Super Secur Fit Plus. Item # J6054-0610 #6-10 Super Secur-Fit Plus. Hip stems are
single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty, Recall # Z-1383-2009;
31) Super Secur Fit Plus. Item #: J6054-0612 #6-12 Super Secur-Fit Plus. Hip stems are single use devices intended for cementless fixation. The products are intended for use in
primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. Recall # Z-1384-2009;
32) Super Secur Fit Plus. Item #: J6054-0711 #7-11 Super Secur-Fit Plus. Hip stems are single use devices intended for cementless fixation. The products are intended for use in
primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty, Recall # Z-1385-2009;
33) Super Secur Fit Plus. Item #: J6054-0812 #8-12 Super Secur-Fit Plus. Hip stems are single use devices intended for cementless fixation. The products are intended for use in
primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty, Recall # Z-1386-2009;
34) Super Secur Fit Plus. Item #: J6054-0913 #9-13 Super Secur-Fit Plus. Hip stems are single use devices intended for cementless fixation. The products are intended for use in
primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty, Recall # Z-1387-2009;
35) Omniflex-HA Hip Stem W/C Taper. Item #: 6046-0425, and Item #: 6046-0830. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty, Recall # Z-1388-2009;
36) Super Secur Fit Plus. Item #: J6054-1014 Primary Super Secur-Fit Plus. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip
arthroplasty, Recall # Z-1680-2009;
37) Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray. Item #: W6021-0335 Accolade (127 deg) Sample. Hip stems are single use devices
intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
Recall # Z-1681-2009;
38) Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray. Item #: 6021-0030 Accolade (127 deg) Size 0. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty, Recall # Z-1682-2009;
39) Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray. Item #’s: 6021-0130 Accolade (127 deg) Size 1. Hip stems are single use devices
intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty,
Recall # Z-1683-2009;
40) Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile, 132 degree neck angle. Item #’s: 6020-5537 Accolade 132 Size 5.5. Hip
stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty, Recall # Z-1684-2009
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on January 6, 2009. Manufacturer: Stryker Ireland, Ltd., Orthopedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.
REASON: Product deviation: Specific lots of sprayed HA hip stems did not meet Stryker’s Internal Material Specification for tensile bond strength and crystallinity.

PRODUCT: Cmax 110v Surgical Table Hand Control. The Cmax Surgical Table is a mobile, electro-hydraulically operated surgical table designed to support all general surgical procedures, with the addition of STERIS table accessories. Tabletop positioning and articulations are controlled via the hand control. Model # 2182625, Recall # Z-1599-2009
MANUFACTURER: Recalling Firm: Steris Corp., Mentor, OH, by letter dated May 12, 2009. Manufacturer: Steris Corp., Montgomery, AL. Firm initiated recall is ongoing.
REASON: A limited quantity of the Cmax Hand Controls, P150832-500, were manufactured without Loctite thread locker on the screws that attach the mounting clip to the hand control case. This clip provides a means of storing the hand control on the table side rails. It is possible that screws without Loctite can work loose and the clip can become separated from the hand control. If both screws back out completely, the internal components of the hand control and/or the table control board may become damaged. This would cause a loss of hand control functionality.

PRODUCT:
1) Offset Adaptor Trial - 2MM, Triathlon Revision Instruments. Non-Sterile; Indications for use include disabling joint disease of the knee. Catalog Number 5570-T-020, Recall #
Z-1607-2009;
2) Offset Adaptor Trial - 4MM, Triathlon Revision Instruments. Non-Sterile; Catalog number 5570-T-040; Indications for use include disabling joint disease of the knee.
Recall # Z-1608-2009;
3) Offset Adaptor Trial - 6MM, Triathlon Revision Instruments. Non-Sterile; Catalog number 5570-T-060; Indications for use include disabling joint disease of the knee, Recall # Z-1609-2009;
4) Offset Adaptor Trial - 8MM, Triathlon Revision Instruments. Non-Sterile; Catalog number 5570-T-080; Indications for use include disabling joint disease of the knee,
Recall # Z-1610-2009
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters dated April 16, 2009. Firm initiated recall is ongoing.
REASON: Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool.

PRODUCT:
1) Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length 0 mm, sterile; Catalog Number: 6428-32-02. Orthopedic implant used in total hip
arthroplasty, Recall # Z-1616-2009;
2) Zimmer Kinectivo Technology Modular Neck, BB, 12/14 neck taper, sterile; Catalog Number: 00-7848-022-01. Orthopedic implant used in total hip arthroplasty, Recall # Z-
1617-2009
MANUFACTURER: Zimmer Inc., Warsaw, IN, by letter dated May 29, 2009. Firm initiated recall is ongoing.
REASON: The corner tab of the inner compartment lid was not folder under before the outer lid was sealed, resulting in lack of assurance of sterility.

PRODUCT:
1) Zimmer Pulsavac Wound Debridement System high capacity intramedullary brush tip, sterile; Catalog Number: 00515018300. Used in conjunction with the Pulsavac Plus
Wound Debridement System for pulsatile lavage/debridement, Recall # Z-1698-2009; 2) Zimmer Allen medullary cement plugs, 1 - 20 dia. flange/10 mm dia. core, 1 - 24 mm
dia. flange/12 mm dia. core (polyethylene with barium sulfate) with inserter, sterile; Catalog Number: 00801102001. Total joint arthroplasty to control, restrict, or impede the
flow of cement. Larger plugs are useful in revision surgery where a wide, smooth Intramedullary canal must be plugged, Recall # Z-1699-2009;
3) Zimmer Coonrad/Morrey total elbow cement restrictor with nozzle, 1 - 16 mm, 1 - 25 mm, sterile; Catatog Number: 32810503800. Total joint arthroplasy to control, restrict or
impede the flow of cement. Larger plugs are useful in revision surgery where a wide, smooth Imtramedullary canal must be plugged, Recall # Z-1700-2009
MANUFACTURER: Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter dated June 8, 2009. Manufacturer: Zimmer Orthopedic Surgical Products, Dover, OH. Firm initiated recall is ongoing.
REASON: The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.

PRODUCT:
1) Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Sizes: 10-24 MM in 1 mm increments, Catalog Numbers: all numbers from 7961810 to 7961824; Rx only,
Sterile. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1796-2009;
2) Medtronic INTREPID Spinal System SPACER, 32X23, 12 DEG, Size: 10-24 MM in 1 MM increments, Catalog Numbers: all numbers from 7961210 to 7961224; Rx only,
Sterile. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1797-2009;
3) Medtronic INTREPID Spinal System SPACER M 37X27, 8 DEG, Sizes 10-24 MM in 1 MM increments, Catalog Numbers: all numbers from 7962810 to 7962824; USA, Rx
only, Sterile. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1798-2009;
4) Medtronic INTREPID Spinal System SPACER M 37X27, 12 DEG, Size: 10-24 MM in 1 MM increments,Catalog Numbers: all numbers from 7962210 to 7962224; USA, Rx
only, Sterile. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1799-2009;
5) Medtronic INTREPID Spinal System SPACER L 42X30, 8 DEG, Size: 10 - 24 MM in 1 MM increments: Catalog Numbers: all numbers from 7963810 to 7963824; USA, Rx
only, Sterile. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1800-2009;
6) Medtronic INTREPID Spinal System SPACER L 42X30, 12 DEG, Size: 10 - 24 MM in 1 MM increments, Catalog Numbers: all numbers from 7963210 7963224; USA, Rx
only, Sterile. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1801-2009;
7) Medtronic INTREPID Spinal System Coverplate, Sizes: Small, Medium and Large; Catalog Numbers: 7961330, 7962330 and 7963330; Sterile. The INTREPID Spinal
System is indicated for use with autogenous bone graft in patients with degenerative disc disease, Recall # Z-1802-2009
MANUFACTURER: Recalling Firm: Medtronic Sofamor Danek USA, Inc., Memphis, TN, by telephone beginning February 6, 2009 and letter dated April 2009. Manufacturer: Medtronic Sofamor Danek Deggendorf GmbH, Deggendorf, Bavaria,
Germany. Firm initiated recall is ongoing.
REASON: The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, and difficulty implanting the cover plate detachment.

PRODUCT: Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300). The VSM300 can monitor systolic and diastolic noninvasive blood pressure (NIBP), pulse rate, and mean arterial pressure (MAP). Units configured with the appropriate options can also simultaneously monitor temperature and noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and continuously monitor pulse rate. The monitor provides programmable audible and visual alarms and automatic NIBP measurements at selectable intervals, Recall # Z-1873-2009
MANUFACTURER: Welch Allyn Protocol, Inc., Beaverton, OR, by letter dated July 28, 2009. Firm initiated recall is ongoing.
REASON: The Welch Allyn VSM300 Vital Signs Monitor may experience a loss of audio which includes a loss of audio alarms.

PRODUCT: Flexicair MC3, model M4000, Low Airloss Therapy Units, for the prevention of pressure sores, Recall # Z-1875-2009
MANUFACTURER: Hill-Rom Manufacturing, Inc., Charleston, SC, by letter dated May 11, 2009 and May 13, 2009. Firm initiated recall is ongoing.
REASON: The devices may emit smoke from the blower box assembly.

CLASS III

PRODUCT: Fusion Omni-Tome, Rx Only, Product order #: FS-OMNI, Recall # Z-1598-2009
MANUFACTURER: Cook Endoscopy, Winston Salem, NC, by letter on June 12, 2009. Firm initiated recall is ongoing.
REASON: The wire control port of these devices may be missing due to omission of a
manufacturing activity.

PRODUCT: G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy, Recall # Z-1710-2009
MANUFACTURER: Volk Optical, Inc., Mentor, OH, by E-mail, letter and fax starting June 30, 2008. Firm initiated recall is ongoing.
REASON: The ring of the Gonio lenses distributed was engraved as, 'G4 High Mag Gonio LNF'; however, the engraving should have read simply: 'G4 High Mag Gonio.'

PRODUCT: Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr, 40cm For Cystometry. Catalog #: CAT-20, Recall # Z-1711-2009
MANUFACTURER: Recalling Firm: Laborie Medical Technologies, Williston, VT, by telephone and e-mail beginning April 10, 2009. Manufacturer: Prince Medical, Ercuis, France. Firm initiated recall is complete.
REASON: Mix up in the labeling and packaging. There were 8Fr catheters mixed inside the 6Fr catheter packages.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 5, 2009:
CLASS II

PRODUCT:
1) GE Datex-Ohmeda ADU Carestation Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. It represents the next system in a long like of products based on the Datex-Ohmeda Excel, Aestiva, Aespire, and Avance Anesthesia Systems, Recall # Z-1633-2009;
2) Datex-Ohmeda AS/3 Anesthesia Delivery Unit An Anesthesia Gas Machine for composition of anesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia. Indicated for all persons that require inhalation anesthesia, Recall # Z-1634-2009;
3) Datex-Ohmeda S/5 Anesthesia Delivery Unit Intended to provide general inhalation anaesthesia and ventilatory support to a wide range of patients. Intended for volume or pressure control, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes, Recall # Z-1635-2009
MANUFACTURER: Recalling Firm: GE Healthcare, Wauwatosa, WI, by letter on January16, 2009. GE Healthcare Finland Oy, Helsinki, Finland Firm initiated recall is ongoing.
REASON: GE Healthcare has received reports of breathing circuit or tubing misconnections of the Anesthesia Delivery Unit (ADU) that may impact patient safety.

PRODUCT: Syngo Imaging Version V31 Picture Archiving and Communication System, model number 10014063, Recall # Z-1650-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, letter dated May 28, 2009. Manufacturer: Siemens Medical Solutions Inc., D-91056 Erlangen, Germany. Firm initiated recall is ongoing.
REASON: Risk of misinterpretation of patient response to treatment: Date displayed may be incorrect. Filtering based on examination date may lead to an incorrect list of examinations.

PRODUCT:
1) Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less, Recall # Z-1651-2009;
2) Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version 2.11 or less, Recall # Z-1652-2009
MANUFACTURER: Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letter on April 14, 2009. Manufacturer: Hitachi Medical Corporation, Tokyo, Japan. Firm initiated recall is ongoing.
REASON: Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect.

PRODUCT: Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502, Recall # Z-1653-2009
MANUFACTURER: Recalling Firm: Arrow International, Inc., Reading, PA, by letter on/about June 17, 2009. Manufacturer: Arrow International de Chihuahua S.A. de C.V., Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON: The spring wire guide is too large in diameter to pass through the needle, dilator and catheter.

PRODUCT: Philips IntelliVue Clinical Information Portfolio Software Version D.0, for patient data collection, storage, and management, Recall # Z-1654-2009
MANUFACTURER: Philips Healthcare, Inc., Andover, MA, by letters on May 6, 2009 and May 27, 2009. Firm initiated recall is ongoing.
REASON: Error in therapy scheduling: If scheduled orders are documented and edited prior to the orders' original schedule time, ICIP can create a second instance of the same order marked as pending. A second instance of an order may result in a patient receiving duplicate therapy or patients may not receive their scheduled therapies.

PRODUCT: Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-90 II (implant set), 54-9020 (instrument case# I), 549030 (instrument case #2), Recall # Z-1655-2009
MANUFACTURER: Recalling Firm: Blackstone Medical, Inc., Wayne, NJ, by e-mail on May 21, 2009 and letters on May 26, 2009. Manufacturer: Blackstone Medical, Inc., Springfield, MA. Firm initiated recall is ongoing.
REASON: Product marketed without an approved 510(k).

PRODUCT: Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10"), Recall # Z-1656-2009
MANUFACTURER: Recalling Firm: Welch Allyn Protocol, Inc., Beaverton, OR, by letter on April 24, 2009. Manufacturer: MRL, Inc., A Welch Allyn Co., Buffalo Grove, IL. Firm initiated recall is ongoing.
REASON: Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing soon. If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device, thereby causing therapy to be delayed or interrupted.

PRODUCT: Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization, Recall # Z-1657-2009
MANUFACTURER: Recalling Firm: Abbott Vascular-Cardiac Therapies dba Guidant Corp., Temecula, CA, by letter dated May 6, 2009 and visits between May 6 and May 8, 2009. Manufacturer: Abbott Vascular, Inc., Redwood City, CA. Firm initiated recall is complete.
REASON: Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedure.

PRODUCT: Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures. Recall # Z-1673-2009
MANUFACTURER: Volk Optical, Inc., Mentor, OH, by letter on January 23, 2009. Firm initiated recall is ongoing.
REASON: Lens may fall onto eye surface during procedure. Ophthalmologic device had a loose set screw on the Ball-Seal bushing assembly. As a result, the set screw becomes disengaged from the set screw groove in the bushing assembly and the Lens Positioning Unit slides downward.

PRODUCT: Somatom Definition Model AS/AS+, Model number 8098027. Intended use: Computed Tomography X-ray system. Recall # Z-1675-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by visit beginning May 29, 2009. Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON: Support mechanism may not engage properly due to improper stowage after opening which may result in internal component damage or potential injury.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 29, 2009:

CLASS II

PRODUCT: Amico E-Cylinder Canister Holder is used to hang E-Cylinders (pressurized gas canisters) from a boom. Product typically used in the surgical setting. Catalog/Product Number: 0682-001-111 and 0682-000-449. Recall # Z-1569-2009
MANUFACTURER: Recalling Firm: Stryker Communications Corp., Flower Mound, TX, by letter dated May 19, 2009. Manufacturer: Amico Corp., Richmond Hill, Canada. Firm initiated recall is ongoing.
REASON: Design flaw on the E-Cylinder canister holder may result in early fatigue and failure of the bracket screws, which could cause the cage to become detached from its mount and fall.

PRODUCT:
1) Tri-State Centurion Venous Access Port Kits, Qty/case 20, sterile, Code No./Reorder KNV80. Each kit contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe, 10mL, REF # 8881590121. Recall # Z-1571-2009;
2) Tri-State Centurion CVC Bundles, Qty/case 10, sterile, Code no./Reorder DT10710. Each bundle contains 3 sterile heparin flush injection solutions as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125. Recall # Z-1572-2009;
3) Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code no./reorder DT9405B. Each tray contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125. Recall # Z-1573-2009;
4) Tri-State Centurion Port Blood Draw Trays, Qty/case 20, sterile, Code no./reorder DT9410B. Each tray contains 1 sterile heparin flush prefilled syringe as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125. Recall # Z-1574-2009;
5) Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code no./reorder KNV50. Each tray contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125. Recall # Z-1575-2009
MANUFACTURER: Recalling Firm: Tri-State Hospital Supply Corp., Howell, MI, by letter dated April 8, 2008. Manufacturer: Mallinckrodt Canada, Inc., Pointe-Claire, Canada. Firm initiated recall is complete.
REASON: The kits contain Monoject pre-fill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.

PRODUCT: XoranConnect, software version 4.1.0.6. A web-based software which provides online multi-planar image viewing, offsite data storage, administrative reporting tools, and teleradiology workflow. Server designed to store and serve stored imaging content on a RAID5 storage device. Recall # Z-1577-2009
MANUFACTURER: Xoran Technologies, Inc., Ann Arbor, MI, by letter dated February 9, 2009. Firm initiated recall is complete.
REASON: An incorrect patient name label may appear on the screen displaying the selected patient’s scan.

PRODUCT:
1) TumorLoc software application, Software Versions: 23.1.1, 20.7.13, and 20.8.15 for use on the GEMINI TF 16 and GEMINI TF 64 Slice PET/CT Systems, Catalog Numbers: 882470 - GEMINI TF 16 Slice; 882471 - GEMINI TF 64 Slice; and 882473 - GEMINI TF 16 Slice Base Configuration. Model Numbers: 4535 679 83931 - GEMINI TF 16 Slice; 4535 679 94741 - GEMINI TF-64 Slice and 4535 674 41711 - GEMINI TF 16 Slice Base Configuration. Tumor Localization is an application used in radiation oncology departments for localizing target volumes for radiation therapy planning. It includes exclusive features for viewing Respiratory Correlated CT data sets and analyzing motion of target and surrounding anatomy. Recall # Z-1578-2009;
2) TumorLoc Software Application, Software versions: 23.1.1, 20.7.13, and 20.8.15. This is an option available for purchase for use on the GEMINI GXL 16 Slice PET/CT System (contains EBW 455011002031 as an accessory), Catalog #882410, Model Number: 4535 679 71891. CT host. 2.2. Tumor Localization is an application used in radiation oncology departments for localizing target volumes for radiation therapy planning. It includes exclusive features for viewing Respiratory Correlated CT data sets and analyzing motion of target and surrounding anatomy. Recall # Z-1579-2009;
3) TumorLoc Software Application for the EBW (Extended Brilliance Workstation, Model # 455011002031, sold as an accessory for the GEMINI PET/CT Systems running CT software versions 3.5.x. , CT host 2.2. Tumor Localization is an application used in radiation oncology departments for localizing target volumes for radiation therapy planning. It includes exclusive features for viewing Respiratory Correlated CT data sets and analyzing motion of target and surrounding anatomy. Recall # Z-1580-2009
MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated February 12, 2009. Firm initiated recall is ongoing.
REASON: A software anomaly in the TumorLoc software for the firm's Brilliance CT scanners was discovered. The same software anomaly was subsequently determined to be present in the firm's GEMINI PET/CT units. The software defect results in a potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.

PRODUCT: ASC2000 Ambulatory Surgical Table. Model #MTS110003. The device is used to provide complete and flexible positioning for surgical procedures. Recall # Z-1597-2009
MANUFACTURER: Recalling Firm: Steris Corp., Mentor, OH, by letter dated April 17, 2009. Manufacturer: Mediland Enterprise, Corp., Tauyen Hsien, Taiwan. Firm initiated recall is ongoing.
REASON: Repetitive rubbing of the hydraulic hoses against the interior of the stainless steel shroud may result in the rupture of the hydraulic hoses causing loss of control of the table surface.

PRODUCT: Duracon Total Knee, A-P Lipped Tibial Insert; 11MM Sterile; Product No. 6642-1-611. The device is used to replace bearing surface if the proximal tibia in order to relieve pain, instability and/or restriction of motion due to degenerative joint disease, failed previous prosthesis or trauma. The tibial inserts are designed to accommodate the posterior cruciate ligament if it is present. These components are intended for implantation with bone cement only. Recall # Z-1601-2009
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on May 5, 2006. Firm initiated recall is complete.
REASON: A box packaged and labeled as a Duracon Total Knee Duration A-P Lipped Tibial Insert 11MM may actually contain a 9MM insert.

PRODUCT:
1) DERMALIFE Spa Jet 2G System. Part #E30006-01 - Spa Jet 2G; Assay w/Pedestal. This is the Spa Jet product including the 2 optional pedestals which the unit can sit on top of. Part #E30006 - Spa Jet 2G; 220V, 50/60Hz. 15A. This is the Spa Jet product without the 2 optional pedestals which the unit can sit on top of. Recall # Z-1602-2009;
2) Dermalife Spa Feng Shui 2G. Part #E30007-100 is: Spa-Feng Shui 2G; 100V 50/60Hz. This is the Spa Feng Shui product without the 2 optional pedestals which the unit can sit on top of, in a 100V version which was produced specifically for our Japanese consignee to meet Japan's specialized 100V electrical requirements. Part #E30007-200 is: Spa-Feng Shui 2G; 200V 50/60Hz. This is the Spa Feng Shui product without the 2 optional pedestals which the unit can sit on top of, in a 200V version which was produced specifically for our Japanese consignee to meet Japan's specialized 200V electrical requirements. Part #E30007-01 - Feng Shui 2G; Assay w/Pedestal. This is the Spa Feng Shui product including the 2 optional pedestals which the unit can sit on top of. Recall # Z-1603-2009;
3) Dermalife Spa-Oceana 2G System. Part #E30008-01 - Spa-Oceana 2G; Assay. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. Part #E30008 - Spa-Oceana 2G; 220V, 50/60HZ-15A. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. that is slightly different than the kit of products included in Part #E30008-01 above. Recall # Z-1604-2009;
4) DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/Pedestal. This is the Spa Jet product re-named for Takara Belmont, identical to Part #E30006-01 other than the stickers on the unit. Recall # Z-1605-2009
MANUFACTURER: Recalling Firm: Sybaritic, Inc., Bloomington, MN, by letter dated April 15, 2008. Manufacturer: Sybaritic Spa Consulting OU, Marjamas, Estonia. Firm initiated recall is ongoing.
REASON: A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. Sybaritic, Inc. conducted a recall on DERMALIFE 2G equipment (SpaJet, Spa Oceana, Spa Feng Shui) because of IR Fan failure which resulted in the overheating and failure of the IR emitter and surrounding assembly.

PRODUCT:
1) Stryker Mantis Rod Inserter; Non Sterile. The MANTIS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disk disease, spodylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion. The Mantis Rod Inserter Assemblies are distributed packaged with a Mantis Rod Inserter Shaft. Rod Inserter Shafts supplies with the Mantis Fod Inserter Assembly, Catalog Number: 48284050. Z-1611-2009;
2) Stryker Mantis Rod Inserter Inner Shaft; Non Sterile. The Mantis Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disk disease, spodylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion. Mantis Rod inserter Shafts supplied separately, Catalog Number: 48284051. Recall # Z-1612-2009
MANUFACTURER: Recalling Firm: Stryker Spine, Allendale, NJ, by letter dated April 29, 2009. Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is ongoing.
REASON: The Mantis Rod Inserter Shaft was found to have deformation of the stainless steel split sphere when subjected to high forces, prohibiting the user from being able to grip the rod implantation and the split sphere may separate and fall into the patient.

PRODUCT:
1) Biomet Biolox-Delta Modular Ceramic Head, 28 mm head diameter, plus 5 neck, type 1, taper, sterile; Catalog Number: 12-115112. A hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. Recall # Z-1613-2009;
2) Biomet Modular TTPA Ceramic Head, 28 mm head diameter plus 5 mm neck, sterile; Catalog Number: RD115112. A hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. Recall # Z-1614-2009
MANUFACTURER: Recalling Firm: Biomet, Inc., Warsaw, IN, by letter dated March 16, 2009. Manufacturer: CeramTec Medical Products Division, Alumina Ceramic Comp. Mf, Plochingen, Germany. Firm initiated recall is ongoing.
REASON: The firm has received reports of fractured heads, requiring revision surgery.

PRODUCT: Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm stem length, w/compression nut, sterile; Model Number: 9982-15-18. Cement-less total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques. Devices placed in femoral canal. A variety of stem and body components are provided to achieve fixation and restore joint kinematics. Recall # Z-1615-2009
MANUFACTURER: Zimmer Inc., Warsaw, IN, by telephone on May 15, 2009 and letter dated May 21, 2009. Firm initiated recall is ongoing.
REASON: The threads on the screw are incomplete/non-functional.

PRODUCT:
1) Triathlon Revision Instruments; 1,2,7,8 TGC Upper Tray; Non Sterile, For total knee arthroplasty procedures involving Triathlon Total Stabilizer components. The trays sterilize and transport instruments needed for such procedures. Catalog Numbers: 6543-8-014, 6543-8-015. Recall # Z-1618-2009;
2) Triathlon Revision Instruments, 3-6 TCG Upper Tray; Non Sterile; for total knee arthroplasty procedures involving Triathlon Total Stabilizer components. The trays sterilize and transport instruments needed for such procedures. Catalog Number: 6543-8-014. Recall # Z-1619-2009
MANUFACTURER: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter dated May 15, 2009. Firm initiated recall is ongoing.
REASON: The screen print for the Valgus Adapter catalog numbers on the Triathlon Trial Cutting Guide Instrument Trays is incorrect.

PRODUCT:
1) Guidant Contak Renewal 3 CRT-D Model H170; 3CRT-D, Model H175; 3HE CRT-D, Model H177; 3HE CRT-D, Model H179; 4CRT-D REF H190; 4CRT-D REF H195; 4HE CRT-D REF H197; 4HE CRT-D REF H199; 4AVT CRT D, REF M177; 4AVT HE CRT-D REF 179. Cardiac Resynchronization Therapy Defibrillator, Sterile EO. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. Recall # Z-1620-2009;
2) Guidant Vitality DS VR Model T135 VR; EL Model T127 DR; 2ICD Model T165 DR; 2ICD Model T175 VR; 2EL ICD Model T167 DR; 2 EL ICD Model T177 VR; DS Model T125 DR. Implantable Cardioverter Defibrillator, Sterile Lot. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. Recall # Z-1621-2009;
MANUFACTURER: Recalling Firm: Boston Scientific CRM, Corp., Saint Paul, MN, by letter dated March 4, 2009. Manufacturer: Guidant Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
REASON: In April 2007, Boston Scientific CRM communicated with physicians regarding the potential for reduced Elective Replacement Indicator (ERI) to Battery End of Life (EOL) time in a subset of implantable defibrillators due to degradation of a low-voltage capacitor. Since that time, the April 2007 advisory population has not experienced any clinically significant changes to either the rate of occurrence or patient management recommendations. A second population (March 2009) has been identified consisting of approximately 900 active ICDs and CRT-Ds (RENEWAL 3/HE, RENEWAL 4/HE, RENEWAL 3 RF/HE, RENEWAL 4 RF/HE, RENEWAL 4 AVT/HE & VITALITY DS DR/VR, VITALITY EL, VITALITY AVT, VITALITY 2 DR/VR, VITALITY 2 EL DR/VR, VITALITY DR HE), manufactured with capacitors from the same supplier that may be subject to the same failure mechanism. No devices from this population have been registered as implanted after April 2007, and the mean age of those remaining implanted is 38 months. No devices in this subset remain available for implant.

PRODUCT:
1) ConforMIS iUni ( Unicondylar Knee System ) Left Medial Implant Kit Product Code: M57220600010. For cemented use only. System consists of femoral and tibial components. The femoral component is CoCrMo personalized on its sub-chondral and articular surfaces to match patient's anatomy. For use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of inadequate healthy bone for support of the implanted component. Recall # Z-1622-2009;
2) ConforMIS iUni ( Unicondylar Knee System ) iUni Right Medial Implant Kit Product Code : M57220600020. For cemented use only. System consists of femoral and tibial components. The femoral component is CoCrMo personalized on its sub-chondral and articular surfaces to match patient's anatomy. For use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of inadequate healthy bone for support of the implanted component. Recall # Z-1623-2009;
3) ConforMIS iUni (Unicondylar Knee System iUni Right Lateral Implant Kit Product Code: M57220600040. For cemented use only. System consists of femoral and tibial components. The femoral component is CoCrMo personalized on its sub-chondral and articular surfaces to match patient's anatomy. For use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of inadequate healthy bone for support of the implanted component. Recall # Z-1624-2009
MANUFACTURER: Conformis Inc., Burlington, MA, by letter dated April 23, 2009. Firm initiated recall is ongoing.
REASON: Microscopic cracks potential for pre-mature revisions in patients implanted with the system.

PRODUCT:
1) Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Part number 8717741. Recall # Z-1648-2009;
2) Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; a) Part number 8717733; b) Part number 10275007; c) Part number 1075008; d) Part number 10275009; e) Part number 10275010. Recall # Z-1649-2009
MANUFACTURER: Siemens Medical Solutions U.S.A. Inc., Hoffman Estates, IL, by letters dated January 20, 2009. Firm initiated recall is ongoing.
REASON: Patient injury can occur when the patient is lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. Detector motions required for this change can cause collision with the patient or pallet if it is in brain scan position, i.e. the patient or pallet is into the field of view.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 22, 2009:

CLASS I

PRODUCT: Paradigm Quick-set Infusion Sets, Models MMT-396, MMT-397, MMT-398 and MMT-399. The Paradigm Quick-set infusion sets are intended for use in combination with Paradigm reservoirs (models MMT- 326 or MMT-332) and Paradigm external insulin infusion pumps to deliver insulin (subcutaneously) to patients who require exogenous insulin to maintain glycemic control. Recall # Z-1705-2009
MANUFACTURER: Recalling Firm: Medtronic MiniMed, Northridge, CA, by letters dated July 6, 2009, July 7, 2009, July 8, 2009 and July 9, 2009 and by press release on July 10, 2009. Manufacturer: Unomedical a/s, Lejre, Demark. Firm initiated recall is ongoing.
REASON: Approximately 2% of the infusion sets in the affected lots may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the syringe compartment with the surrounding atmosphere. If the vent does not work properly, this could potentially result in too much or too little insulin being delivered.

CLASS II

PRODUCT: Hydration Station with Pedestal (Part # E30003-01), Hydration Station with Pedestal & DVD (Part # E30003-01D). Recall # Z-1245-2009
MANUFACTURER: Recalling Firm: Sybaritic, Inc., Bloomington, MN, by letter dated May 15, 2007. Manufacturer: Sybaritic Spa Consulting OU, Marjamas, Estonia. Firm initiated recall is ongoing.
REASON: Sybaritic conducted a recall on the Hydration Station 806 because of the potential for hot water to spurt through steam ports into unit and cause burns. Also, potential for customers to inadvertently place their legs over the side wall of the unit directly onto the steam ports and cause burns. There were 18 injuries and 8 malfunctions reported.

PRODUCT: TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model #4550 116 02431 (TumorLoc). The BB is a CT X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. Recall # Z-1542-2009
MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated January 28, 2009.
REASON: A software error in the TumorLoc software was discovered upon receipt of a customer complaint. There is the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.

PRODUCT: GE Centricity PACS RA1000 Workstation software (for diagnostic image analysis); The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure. Recall # Z-1543-2009
MANUFACTURER: GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated March 2, 2009. Firm initiated recall is ongoing.
REASON: Software anomalies may allow the image orientation to be misinterpreted, posing a potential patient safety issue.

PRODUCT: Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Intended for use of the software is to control capture, display, treatments, analysis and saving of x-ray digital images. Recall # Z-1548-2009
MANUFACTURER: Gendex Dental Systems, Des Plaines, IL, by letter dated March 6, 2009. Firm initiated recall is ongoing.
REASON: There is a compatibility issue when the VixWin Platinum versions 1.0/1.1/1.2 software is used in conjunction with Easy Dental, PracticeWorks, EagleSoft and SoftDent practice management software, resulting in patient files that may contain images that are mixed between patients.

PRODUCT: 1) Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00, EC2S24, EE1S048 and EE2S21. Kits are packaging convenience kits containing previously released sterile-pack products and accessories. Recall # Z-1550-2009;
2) Medtronic One Source Pack Magellan, Catalog Number: COS310. Kits are packaging convenience kits containing previously released sterile-pack products and accessories. Medtronic Ideal MAXPAC Total System. Recall # Z-1551-2009;
3) Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R, TS1420R1, TS1442R, TS1446R, TS1464T, TS1470R, TS1470T1, TS1480R3, TS1480R5, TS1480R6, TS1487R, TS1487R2, TS8040R28, TS8108R6, TS8163R10, TS8387R5, TS9412R3, TS9453R28, TS9764R9, TS9800R28, TS9800R29, TS9800R31, TS9987R33 and TS9987R34. Sterile and nonpyrogenic, EtO or Gamma Sterilized. Medtronic Purfusion Systems. Kits are packaging convenience kits containing previously released sterile-pack products and accessories. Recall # Z-1552-2009
MANUFACTURER: Medtronic Cardiovascular Revascularization & Surgical Therap, Brooklyn Park, MN, by letter dated March 23, 2009. Firm initiated recall is ongoing.
REASON: Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates on the outer kit package label. The Use Before Date on the outer label of the kit/pack does not accurately reflect the Use Before Date of the components within the kit/pack. For affected product, the outer label lists a date which exceeds the earliest Use Before Date of the components included in the kit/pack. Medtronic requests that you immediately quarantine this product. Affected product should be returned to Medtronic.

PRODUCT: Waste bottles Part Numbers/Article Numbers: a) 905-590/D512 and b) 905-802/D513. The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing. Recall # Z-1554-2009
MANUFACTURER: Recalling Firm: Radiometer America Inc., Westlake, OH, by letter dated May 5, 2009. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON: When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle.

PRODUCT: Siemens Stratus CS Acute Care Troponin I CalPak. In vitro product intended to be used for calibration of the cardiac troponin I method on the Stratus CS analyzer. Recall # Z-1555-2009
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated April 29, 2008. Firm initiated recall is complete.
REASON: The firm received and confirmed that some lots of Cardiac Troponin I (cTnl) CalPaks (CCTNI-CR) may exhibit calibration issues that cause lower than typical signal during calibration with the current population of cTnl TestPaks (CCTNI). This issue may result in failed calibrations due to "Slope Error" messages or falsely elevated patient sample and quality control (QC) results on calibrations that are within the calibration guidelines (no Slope Errors).

PRODUCT:
1) Smith & Nephew Endoscopic Disposable Blades: Full Radius Blade, 5.5MM, SER 3000 Part #: 7206010. Dyonics Series 3000 Bonecutter Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty. Recall # Z-1560-2009;
2) Smith & Nephew Endoscopic Disposable Blades: Stonecutter ACR, 4.0, EP-1, DSP Part #: 7205330. Dyonics Series 3000 Bonecutter Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty. Recall # Z-1561-2009;
3) Smith & Nephew Endoscopic Disposable Blades: Notchblaster ABR, EP-1,5.5 DSPL Part #: 7205329. Dyonics Series 3000 Bonecutter Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty. Recall # Z-1562-2009;
4) Smith & Nephew Endoscopic Disposable Blades: Incisor, 5.5mm, EP-1, DSPL Blade Product #: 7205314. Dyonics Series 3000 Bonecutter Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty. Recall # Z-1563-2009;
5) Smith & Nephew Endoscopic Disposable Blades: Disposable BL, 4.5MM FR Elite Part #: 7210499. Dyonics Series 3000 Bonecutter Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty. Recall # Z-1564-2009;
6) Smith & Nephew Endoscopic Disposable Blades: Boxed F/R, BL, 4.5MM, Series 3000 /6 Product #: 7206011. Dyonics Series 3000 Bonecutter Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty. Recall # Z-1565-2009;
7) Smith & Nephew Endoscopic Disposable Blades: Incisor Blade, 3.5MM DSPL, EP-1 Part #: 7205312. Dyonics Series 3000 Bonecutter Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty. Recall # Z-1566-2009;
8) Smith & Nephew Endoscopic Disposable Blades: Turbowhisker BLD, EP-1, 4.5MM (6) Part #: 7205316. Dyonics Series 3000 Bonecutter Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty. Recall # Z-1567-2009
MANUFACTURER: Recalling Firm: Smith & Nephew, Inc. Endoscopy Division, Andover MA, by letter dated May 5, 2009 and/or by e-mail on May 7, 2009. Manufacturer: Avail Medical, Juarez Chih, Mexico. Firm initiated recall is ongoing.
REASON: Product sterility is compromised due to breach in the sterile packaging.

PRODUCT: Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Recall # Z-1570-2009
MANUFACTURER: Advanced Sterilization Products, Irvine, CA, by letter dated January 12, 2009. Firm initiated recall is ongoing.
REASON: The capacitor in the vacuum pump component within the Sterrad 50 System could overheat and potentially create a hazardous condition inside the system, resulting in smoke and/or fire.

CLASS III

PRODUCT: Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010. Recall # Z-1576-2009
MANUFACTURER: Recalling Firm: Inovel LLC, Culver City, CA, by letter on July 23, 2007. Firm initiated recall is complete.
REASON: Display boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 15, 2009:

CLASS II

PRODUCT: Zimmer TM-400 Broach Handle; Part No. 96-210-10001. The product is a surgical instrument for use in conjunction with Zimmer TM-400 Trabecular Metal implants during spinal surgery. The Broach Handle threads onto various broaches and trial implants. The handle with these broaches or trials attached is used to prepare and measure a vertebral space to accept a TM-400 Trabecular Metal implant. Recall # Z-1246-2009
MANUFACTURER: Recalling Firm: Zimmer Inc, Warsaw, IN, letter dated April 29, 2009. Manufacturer: Zimmer Trabecular Metal Technology, Inc, Parsippany, NJ. Firm initiated recall is ongoing.
REASON: The broach handle may fracture at the threaded tip during use, which would result in surgical intervention to retrieve the broach or the trial as the threaded tip fragment prevents attachment of another handle to retrieve the device.

PRODUCT: 1) Genicon, RX Only, Sterile EO. Catalog Number 700-005-010, 5MM. A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage. Recall # Z-1406-2009; 2) Genicon, RX Only, Sterile EO. Catalog Number 700-010-005, 10MM (Foreign Distribution Only). A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage. Recall # Z-1407-2009
MANUFACTURER: Genico, Inc, dba Genicon, Winter Park, FL, by e-mail and fax on May 8, 2008. Firm initiated recall is ongoing.
REASON: Genicon is recalling the Genicon Disposable Suction Irrigation 5mm 700-005-010 and 10mm 700-005-005 Tube Sets. The caps on the trumpet valves of the devices could fall off, resulting in the malfunction of the Suction Irrigation Device.

PRODUCT: 1) BrainLab Micro-Multileaf-Collimator, model 41600; The mMLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from access radiation; Model 41600. Z-1544-2009; 2) BrainLab M3 Micro-Multileaf-Collimator for Varian Type III with MLC, model 41600-3; The mMLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from access radiation; Model 41600-3. Recall # Z-1545-2009;3) BrainLab M3 Micro-Multileaf-Collimator for Siemens Mevatron Digital Type III with MLC, model 41600-5, -5 A; The m MLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from access radiation; Model 41600-5A. Recall # Z-1546-2009;4) BrainLAB M3 Micro-Multileaf-Collimator for Elekta/Philips Type III with MLC, model 41600-06, -6 A; The m MLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from access radiation. Model 41600-6A; Recall # Z-1547-2009
MANUFACTURER: Brainlab AG, Kirchheim B Muenchen, Germany, by letter dated March 19, 2009. Firm initiated recall is ongoing.
REASON: The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended conformal fields of the BrainLab m3 micro-Multileaf-Collimator (mMLC) during patient treatment.

PRODUCT: Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468. Recall # Z-1553-2009
MANUFACTURER: Recalling Firm: Cyberkinetics Neurotechnology Systems, Inc, Foxboro, MA, by e-mail on February 4, 2009. Manufacturer: Blackrock Microsystems (DBA), Salt Lake City, UT. Firm initiated recall is ongoing.
REASON: Sterility of product cannot be assured.

PRODUCT: Siemens Stratus CS Acute Care Troponin I CalPak. In vitro product intended to be used for calibration of the cardiac troponin I method on the Stratus CS analyzer. Recall # Z-1555-2009
MANUFACTURER: Siemens Healthcare Diagnostics, Inc, Newark, DE, by letter dated April 29, 2008. Firm initiated recall is complete.
REASON: The firm received and confirmed that some lots of Cardiac Troponin I (cTnl) CalPaks (CCTNI-CR) may exhibit calibration issues that cause lower than typical signal during calibration with the current population of cTnl TestPaks (CCTNI). This issue may result in failed calibrations due to "Slope Error" messages or falsely elevated patient sample and quality control (QC) results on calibrations that are within the calibration guidelines (no Slope Errors).

PRODUCT: Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1. a) Model #455011202691 for Computed Tomography (CT); b) Model #455011002031 for Nuclear Medicine (NM). The "Extended Brilliance Workspace (EBW)" Dental Application v4.0 and v4.0.1 is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-1568-2009
MANUFACTURER: Philips Medical Systems (Cleveland) Inc, Cleveland, OH, by letter dated April 27, 2009. Firm initiated recall is ongoing.
REASON: Philips Healthcare has recalled the Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1 due to the fact that when images are saved or filmed that contain the Curved Multi-planar Reformation Section (cMPRS) views that were created with a short curve the Right/Left annotations will be reversed.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 8, 2009:

CLASS I

PRODUCT: Respironics BiPAP Focus Noninvasive Ventilator System. The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, respiratory failure or to maintain airway patency and provide respiratory support to patients who experience obstructive sleep apnea. Nasal and full face masks are used with this device. The BiPAP Focus is intended for use in acute, sub-acute and intra-hospital transport settings. Model Numbers: 8-400169-00, 7-400076-00, 8-400179-00, 8-400258-00, 8-400259-00, 8-400260-00, 8-400261-00 and 8-400216-00. Recall # Z-1606-2009
MANUFACTURER: Recalling Firm: Respironics California Inc, Carlsbad, CA, by letter dated September 22, 2008. Manufacturer: Respironics, Inc, Murrysville, PA. Firm initiated recall is ongoing.
REASON: Power Supply failures have occurred on some ventilators. A discrepancy between the power supply strain relief clip and the power cord connector may allow unwanted movement of the cord and the unit's power supply. A disconnection or intermittent electrical connection between the power cord and the unit's power supply during operation or charging can result in transient power surges, which may cause damage to components within the power brick. A power surge may exceed the power supply capacity, causing the power supply to lose power. These failures were discovered through routine product monitoring and to date Respironics California Inc. has received no reports of patient injury.

CLASS II

PRODUCT: Ceiling Tube Mount Ceiling Tube Mount (CTM)/Digital Ceiling Tube Mount (DCTM) with 5 inch (Part 114-0304G2) or 10 inch Column Extensions (Part 114-0304G1); a radiographic x-ray tube suspension system designed to facilitate a wide range of procedures. The device is used for X-Ray tube positioning. Recall # Z-1247-2009
MANUFACTURER: Del Medical Systems Group, Franklin Park, IL, by letter on January 12, 2009 - February 4, 2009. Firm initiated recall is ongoing.
REASON: There is the potential for the supporting cable to become detached from the column causing the column to fall and possibly contact the patient or operator.

PRODUCT: 1) GE Datex-Ohmeda Aisys, Anesthesia Gas-Machine. Recall # Z-1425-2009; 2) GE Datex-Ohmeda Advance Anesthesia Gas-Machine. Recall # Z-1426-2009
MANUFACTURER: Recalling Firm: G Healthcare, Wauwatosa, WI, by letters dated February 5, 2009 and March 10, 2009. Manufacturer: Datex - Ohmeda, Inc, Madison, WI. Firm initiated recall is ongoing.
REASON: Unintended shut-down: The anesthesia machine may start shutting down without human intervention due to a faulty On/Standby Switch. Prior to shutdown, the system will issue an alarm and play a message that shutdown will occur in 8 seconds. The failure only affects the electrical portion of the switch. If the clinician does not intervene, the patient could experience hypoventilation leading to hypoxia.

PRODUCT: 1) GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System. The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. System ID Numbers: ZA2239RX01, 857307IN421, 417347FCV2, 262687CL2, 409938INV21, 516632INNOVA1, 704384CL21, 505848CATH1, 505848EP, 318448INNOVA3, 305682IN2, 410554INNOVA2, 208367INNOVA, 208381CCL1, 2035762100, 717217CA10002 (717217INN21), 843797TCL1, 214947MINNOVA, 214947MINNOVA2, PRESBYDEP, 303839CL2, 252384CATH1, 303788CL1, 4436432100, 4107872100, 8184092100, 864255SFCL2, 219932DCL2, 305364P2100, 954987CL4, 713794LAB1, 727869CATH3, 727869CCL2, 727869EP5, 208227CATH1, 8157412100, 816861KCVAI2, 308865GIN1, 865693CCL, 865693CCL2, 608775NOVA2, 310825INNOVA21, 516562INNOVA6, 516562INNOVA7, 865977CCL, 217383CCL2A, 541732CV2, 251435ICV3, 239436CATH4, 732776CATH4, 212305CATH1, 212604INNOVA1, 65049321, 304424INNOVA, 610983INNOVA2, 201447LAB1, 215453INNOVA21, 253627INNOVA1, 229228INNOV21C, 8053702100, RPINNOVA2100, 303425CL3, 317355INNOVA3, 318448CA1000 (318448INNOVA3), 330363LAB3, 330375LAB2, 336538ARCL1, 360456XCL4, 405604D2100, 408559INV1, 410554INNOVA1, 414291CL2, 414649INNOVA2, 417269SCLA, 417347FCV4, 423495MCATH1, 501257VALAB1, 508856IN21, 509575YM2100, 516562INNOVA2A, 518243LAB1, 518243LAB2, 561548ET2, 570476INNOVA21, 573761SMC2, 573815BCR2, 573815BCR3, 573815BCR4, 574535IN21, 602239CLAB2, 607737CL1, 608775NOVA1, 610250INNOVA1, 610250INNOVA3, 610776INNOVA21, 612273INNOVA2, 615284CV3, 615342CV3, 615446CV1, 617636CL1, 630856H2100, 650369SV4, 651582IN3, 661327INNOVA1, 661327INNOVA2, 706291CLIN1, 713375U2100, 713375UCA, 717217INN21, 717544GECATH2, 717544GECATH3, 718470EP, 718780CATH3, 727942CATH2, 732324INN1, 732923INN, 770HMCCL1, 781340IN1, 781340IN3, 785354HRTEP, 803256PCL5, 808547QCV1A, 808547QCV3A, 812238UN21, 813615CL1, 813615CL8, 813615CL9, 813615EP3, 814452EP, 815759CARDIAC1, 817329BG2100, 843724CL1, 843724CL2, 843724CL3, 843724EP1, 845368LAB1, 845368LAB2, 856853IN2100, 858554INNOVA2, 858554INNOVA3, 864255SFCL1, 904597CATH, 910343EP1, 910343EP2, 910671INOV21, 916781INNOVA2, 937208INNOVA2, 954735CL2, 954987CCL7, 954987CCL8, 970350CL2, 9704CHINNOVA, 973579LAB1, 985898INNOVAA, 985898INNOVAB, CM2100, ECXV1406F, FHOMEP, 508941IN21, 508335INNOVA, 843692CATH3, 828213IN21, 901765EP, 410554INNOVA4, 410554INNOVA3, 251435ICV7, 262255INNOVA2, 303369HCL4, 410337INNOVA6, 573256MHC, 804764CATH2, 845365V13, 7023602100, 9284532100, 336832MCCL6, 402559UCD, 775982INN2100, 847316INNOVA1, 847316INNOVA2, LVINOV7, 0002651218X, 402559UCC, 4105502100XX, 0002507622X, 845368CATH1, 845368CATH2, 262687CL1, 336538ARCL, 619457INNOVA6, 949250I21, 630856H21EP, 202782LABC, 619457INNOVA5, 336538ARCL, 610988INNOVA5, 508422IN21, 630856H21EP, 303629EP2, 853060191, 853060197, 853060193, 853060195, 853060199, 853060199, 34097VAS01, 01031VAS01, 71004VAS01, 06052VAS01, 20001VAS02, 34009VAS06, 34134VAS02, 35049VAS01, 58010VAS01, 80002VAS01, 06004VAS03, 35021VAS02, 34097VAS01, 34280VAS01, SY1001VA02, SY2005VA01, SK1083VA01, SK1064VA01, SK1110VA01 , SI4069VA01, 847160002, 847160003, A004RX01, A020RX13, SD1038VA01, SA1011VA01, SA1054VA02, PER00218, 787844INNOVACL1, 787844INNOVACL2, 787844INNOVACL3, PL1101VA03, 600151VA01, 600042VA03, PL1677VA01, 843160005, 2737019, 2752691, 920169006, NO1009VA03, NO1064VA03, 644INNOVA21, 83INNOVA2588441, 81INOVAISSSTE08, 36INOVA2733687, MA1004VA02, LV4000VA02, LV4000VA03, LV4001VA02, LT4000VA04, LB1042VA01, KW1018VA05, KW1018VA01, KW1018VA02, KW1018VA03, 850060723, 850060729, YV0054, YV0057, YV0058, YV0059, YV0060, YV0061, YV0062, YV0063, YV0064, YV0065, YV0066, YV0067, YV0068, YV0070, YV0071, YV0072, YV0073, YV0074, YV0075, YV0076, YV0077, YV0078, YV0079, YV0080, YV0081, YV0100, YV0055, YV0056, YX1483, YV0082 , YV0083, YV0085, YV0088, YV0088, YV0086, YV0085, YV0090, D5810523, A5129022, A5333036, A5333037, A147111802, A5125125, A5129025, A5131858, A5155141, A5164510, A5219606, A5220710, A5286803, A5400910, A5605743, A5624112, A5800506, A5807919, A58080104, B5120723, C5123625, C5123626, C5323515, A5624127, A5697709, A5764002, B5603933, A5111034, D5810523, IR1748VA01, 8.30E+13, 2644132, 8.3016E+12, 083016002101586 (83016002101581), 8.30161E+13, 8.30162E+13, 8.30162E+13, 8.30162E+13, 8.30163E+13, 8.30166E+13, 8.30168E+13, 8.30168E+13, 8.30168E+13, 8.30169E+13, 8.30169E+13, 8.30169E+13, 8.30168E+13, 8.30169E+13, 8.30166E+13, 8.30168E+13, 8.30168E+13, 8.30E+12, 8.30E+13, 8.30E+13, 8.30E+13, 8.30E+13, 8.30166E+13, 8.30E+13, 8.3016E+13, 8.30168E+13, 8.30166E+13, 8.30168E+13, 8.30168E+13, 8.3016E+13, IE1100VA02, 835160025, 835160024, 835160017, 835160018, 835160021, 835160022, GOLD001958, GOLD001985, 600010VA01, HU1094VA01, HU1116VA01, HU1205VA01, HU1231VA10, 828160008, 828160007, 2704830INNOVA, H2077VAS27, H17654VAS8, 553003XR01, 10086VAS06, 00060VAS02, 00159VAS04 (10086VAS06), 00192VAS04, 00192VAS05, 00234VAS01, 00282VAS02, 00371VAS01, 00440VAS02, 00440VAS03, 00463VAS06, 00888VAS02, 01065VAS01, 05208VAS02, 05217VAS02, 05451VAS01, 10507VAS01, 00197VAS01, 10086VAS04 , A4166952, B1650215, B5483438, M1334109, M2068110, M2569315, M2844529, M4176519, M4183841, M4200108, M4211066, M4496941, B4192944, M2621511, M4198195, M181374801, FI1017VA02, FI1017VA03, FI1025VA01, FEB52055, ME612436, CEE15663, UPW21603, EG1729VA01, EG1029VA01, EG1729VA01, EG1029VA01, EG1741VA01, DZ1006VA01, DK1066VA02, HC4348XR02, PC0052XR07, PC0052XR08, 507902XR01, HC0222XR35, HC4355XR06, HC4480XR05, HC1995XR03, CS1118VA03 (CS1313VA01), CS1006VA04, 2664023INNOVA, 2696283INNOVA, 26814ANGI2, 82416310009, 468668XR01, 905848INNOVA1, 416864INNOVA2, 604875AINNOVA1, 416480INNOVA, 604682INNOVA1, 604682INNOVA2, 604875AINNOVA2, 416864INNOVA, 82416100014, 82416150002, 82416130026, 82416010005, 82416010007, 82416030005, 82416040011, 82416040012, 82416040014, 82416050003, 82416060001, 82416070006, 82416100009, 82416100012, 82416100017, 82416120008, 82416130016, 82416130019, 82416130023, 82416130024, 82416160007, 82416180003, 82416200004, 82416210007, 82416220010, 82416120009, 82416030004, 82416100007, 82416140006, 082416ATCINNOVA, 82416110005, 82416230002, 82416100015, 82416200007, 82416270003, 82416210010, 82416310010, 82416210010, 82416100020, 82416010008, 2673668, 1239682, 2721872, 2632834, 2730446, 010120RX44, 910162009, 910162010, 910162011, 910162012, 910163011, 910163014, 910162013, 910162014, 910162014 and DZ1050VA01. Recall # Z-1474-2009;
2) GE Innova 3100 / 3100 IQ Cardiovascular Imaging System. The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. System ID Numbers: 388567772VASMET, 704384PHMCATH, 509946CATH2, 262687CL3, 318798CL1, 507385INN3100, 8189813100, 219877IN2 , 865512CL3, 704878CL31, 718250CATH1, 912486CATH1, DR3100, 417347FCV5, LVINOV4, 308865GIN2, 925779INNOVA408, 215576INNOVA1, 760242CATH1, 404686CRI3, 281420LAB23100, 541382CV3, 205783BCL5, 2035763100, 508941IN1, 843797TCL2, 361980INNOVA2, 214590PH3100, 303629CL4, 303629EP, 3027443100, 7018573100, 303788CL2, 239939CLA, 850862IN3100, 352333CATH1, 352333CATH2, 8184093100, 919731WMINOV, 305364P3100, 205877CCL1, 281440CL3, 208227CATH2, 2014183100, 7028533100, 865693CCL1, 609757IN3100, 6619483100, 219326IN31, 7022333100, 816969LSCATH, 209334LINNOVA1, 310319SM3100, 502587LAB1, 219877IN31, 9734293100, 215335INNOVA1, 239436CATH3, 239513CRLAB1, 8053703100, 615222H, 812858GWLAB1, 812858GWLAB2, 8014793100, 270688INN, 65049331, 850747BR3100, 6106483100, 8508573100, 850469BCV1, 207662CL4, 207879CL131, 951788INNOVA3, 951788INNOVA2, 541677MINNOVA1, 5033703100, 253968INNOVA, 254742KDCL1, 662377CV4, 412437INNOVA, 9202623100, 303425CL4, 2197573100, 228818VASC, 316651INNOVA31, 316962WCVC1, 316962WCVC2, 325428CATH1, 325428CATH3, 336832MCPV, 360456XCL3, 361857CATH1, 405272SCL2, 405372S3100, 405604D3100, 405840OIC3100, 406447VAIN3, 406543IN3, 413582C3100, 414447CL1, 414647CL1, 414649CL3, 414649CL4, 414805INNOVA1, 415925INV1, 417885JCL7, 417885JCL8, 423495MCL6, 423844CCL1, 478274CTH1, 502852INNOVA, 510797INV8, 512901NI3100, 516562INNOVA8, 516562INNOVA9, 516663INNOVA1A, 530244XC106, 561548CL4, 570476INNOVA31, 573458CL1, 573632CRC2, 6012883100CV2, 603421PCL, 610595CL1, 610770INNOVA31, 610983INNOVA1, 616392INNOVA, 617732IN9, 618241GSI3100, 620225INNOVA31, 631968INNOVA2, 631968INNOVA3, 662377CV2, 671GMHAINVA, 708WESTSUB3100, 713359INC, 713948INA, 717782INNOVA31A, 718245UNITY, 718470INNOVA2, 718780CATH2, 732776CATH6, 770991CL1, 772LWCL1, 775982CATH2, 781340IN2, 803255CL1, 804285CATH1, 814676C1, 815344CARDIAC3, 815756KCHSPEC, 816478MC1, 816861KCVAI1, 816943STJIC1, 816985NKCI, 847362CONCATH4, 856596IN3100, 864255SFCL3, 901516R3, 903UT3100, 904276CTH1, 909464IN3, 909825VAINNOVA, 910343NHIN4, 913345MI1, 940626DCH3100, 954987CCL9, 956698INN31, 970350CL1, 970945CL1, 973877LAB4, ECXV1406B, FHORLCL7, 580548B3100, 941798CLAB2, 760323DRINNOVA, 718270INNOVA1, 603580ECL1, MARTINSVILLE310, 480728LAB2, 865481CCL2, 405610NW3100, 8157413100, 251633PROV, 907562CATH1, 919784REP1, 601883CL1, 650369SV3, 610954INNOVA1, 760242CATH2, 314768SMCL1A, 2035763100A, 402559UCB, 561694IN1, 2036883100, 201996LAB1, 205877CCL2, 207351YCL1, 251435ICV6, 281420LAB1, 314525STACL2, 334418CL, 412623LAB2, 479441SP3100, 480821IN2, 508856IN2, 541MWHINNOVA, 573882UMC1, 610447CL1, 610526LAB1, 610526LAB2, 610891CL1, 617789IN1, 631376EP, 704384CATH2, 706481CCL, 706774CCL4, 706774CCL5, 713776M3100, 717782INNOVA31, 803256PCL1, 812450CATH1, 815226INN2, 863687CL31, 916781INNOVA1, 918494IN31A, 952993INNOVA5, BPINNOVA1, 845365V19, 918333JPIN1, 909788INNOVA1, 516663INNOVA2, 2652143 MARTINSVILLE310, 8185023100, 312STMNAZ3100, 630312B31, 717782INNOVA31B, 727725CATH2, 785354S3100, 918333JPIN2, 812450EP1, 316268INNOVAA, 717217INN31, 310825INNOVA31, 413540IN1, 615222HX, 850747GC3100, 516632INNOVA2, 314768SMCL3, "617789WS1, 617789IN1, "9734293100AW, 9734293100, "903UTAW31, 903UT3100", 870864LAB2, 815599FHN3100, 630856H31, 678957INNOVA, 0002676826X, 337374INNOVA, 727521CATHOP, 720225CL2, 678957INNOVA, 704355RM2, 609267IN3100, 9287883100, 541743CL6, 405636ISW3100, 575521CATHB, 9284533100, 443481EP, 504447INNOVA2, 931459CV1, 650723SC2, MCDCATH2, 732776CATH2, 812238LIB1, 313593IC1, 650938LY31, 609597IN3100, 853060194, 06074VAS01, 34115VAS02, 44009VAS01, 01012VAS01, 41018VAS01, 58002VAS01, 60001VAS01, 34268VAS01, SA1010VA02, RU3053VA01, RU1449VA01, RU1102VA02, RU1254VA01, 600098VA01, RU1482VA02, RU1475VA01, RU1142VA01, RU2581VA01, RU1457VA01, RU2741VA01, RU1692VA01, RU1001VA02, RU1913VA02, RU3136VA01, RU3137VA01, RU3135VA01, RU2886VA01, PL1650VA02, PL1688VA01, PL1681VA01, PL1640VA01, PL1082VA01, 600050VA02, PL1491VA01, 2048000INNOVA, 2664627INNOVA, 2685467INNOVA, 2716439INNOVA, 920169007, NO1005VA05, 834160003, 477XVIN2553211, 52XVINN2565367, 818INNOVAHM2, 0002714567B, LB1148VA01, LB1003VA01, KW1055VA01, 850060719, 850060724, 850060726, 850060727, 850060728, YV0165, YV0162, YV0048, YV0163, XF0250, YV0033, YV0034, YV0035, YV0038, YV0039, YV0040, YV0042, YV0043, YV0044, YV0045, YV0046, YV0047, YV0049, YV0050, YV0051, YV0023, YV0024, YV0025, YV0027, YV0028, YV0029, YV0030, YV0031, YV0032, YV0037, YV0164, YV0052, YV0168, YV0167, JO1000VA01, A5718004, D5810520, A5812258, A5127281, A5112597, A5162256, A5333035, A5812244, B5274834, B5332001, B5810907, A5125119, D5810520, IQ1165VA01, IR1819VA01, HU1099VA04, H17654VAS9, H4672VAS02, GE1009VA01, GE1005VA01, GE1004VA01, 01243VAS03, 00203VAS01, 01367VAS02, 01243VAS03, M2030709, M4163030, M4166988, M5480755, M6083613, A6017504, M2848425, M4016034, M40480151, A9190149, M40480167, FI1064VA01, MPX82206, FPG86403, FPG93008, DPM32143, DPN88402, FPA99414, 2655786INNOVA, HC4348XR01, CS1006VA03, 2625365INNOVA, 2645993INNOVA, 2735407INNOVA, 82416220009, 82416190004, "82449120026, 082416120007, 82416160012, 82416210009, 82416130027, 82416040018, 82416140004, 82416290001, 82416140003, 82416130018, 82416080001, 82416010006, 82416020004, 82416020005, 82416030006, 82416040015, 82416040019, 82416100013, 82416110002, 82416110003, 82416120010, 82416140002, 82416150001, 82416160008, 82416160009, 82416160013, 82416180004, 82416190004, 82416190001, 82416190002, 82416190003, 82416210006, 82416210008, 82416220008, 82416270002, 82416300001, 82416310003, 82416310006, 82449100050, 82416160011, 82416170002, 82416030003, 82416030008, 82416030010, 82416100006, 82416100010, 82416100019, 82416120007, 82416120011, 82416130015, 82416160003, 82416160006, 82416210003, 82416210004, 82416310007, 82416220009, 82416130017, 82416030009, 82416120012, 82416180005, 82416310008, 82416040017, "82449030045, (082416030006)", 82416150003, 82416130028, 82416150003, 82416150003, 82416130028, 82416130018, BE5003VA02 (BY4015VA02), BY4066VA01, 2722671, 2722497, 2573329, 2676587, BG4549VA02, 140024RX09, BA4080VA01, 910064009, 910163012, 910163013, 910163015, 910064007, 910064008, 910162006, 910162008, 910163006, 910163007, 910163009, 378INV31, 4127INV31, TT-2586581-CO, 818INNOVAHM1, YV0167 and 82416290002. Recall # Z-1475-2009;
3) GE Innova 4100 / 4100 IQ Cardiovascular Imaging System. The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. System ID Number: 304347INNOVA2, 574647IN2, 317621PVAW 317621PV , 248849SP1, 412784LAB1, 412784LAB2, 7087564100, 478765ANG1, 209467INNOVA308, 620665INNOVA41, 409212INOV41, 727398SPEC1, RADNETXV2, MCL4100, 601376SP4100, 718250ANGIO, 615284OR15, 618549CM4100, 419557ORLAB, 3184734100, 706774USP3, 6309784100, 6616324100, 304256INNOVA, 2035764100, 352596SPEC, 423495MSPEC2, 5135844100, 719560INN41, 303320OR41, 303399IR, 303436ANGIO, 3027444100, 574294IN41, 239939INNOVA, 252847PRS3, 864255SF4100, 305823IN4100, 7137764100, 3016094100, 414649CL2, 812858GWSP, 212639ACT1, 8014794100, 304424CCINOVA, 309655FSP1A, 4134474100, 5033704100, 509474SH41, 201541SP1, 281401T4100, 918744JR4100, 22925941V2, 586573SP1, 314569SJRM12, 314966DPHSP, 317887INNOVAPV, 330489SPEC9, 352333INVOR, 386254HS1, 386254HS2, 386HPOS1, 404466SF41A, 404GHSIR1, 410337INNOVA2, 412647OR10, 414649DVI, 419696LAB1, 505848CATH2, 505848V4100, 508650IN41, 509482HFI, 512901NI4100, 530888ANG206, 541686SPR1, 561548VAS2, 570321LAB2, 605333RM10, 610988INNOVA4, 617636IN1, 619229INNOVA1, 623848SP, 630275G41, 630275G41B, 650493ANGIOCT, 662244GTSP, 678EJCIR1, 706291RINN2, 706651SP1, 706733SP1, 708783CL4100, 708783SP4100, 713375U4100, 718630LIBERTY, 727791INNOVA, 770535N4100, 803256SP, 804594ANGIO, 812238UN41, 812825INNOVA1, 813615CL10, 815740SC4100, 817465AR4100, 817922BA4100, 843577CL2, 845368RM10, 850747IN4100, 863687INV24, 864573LAB2, 865373SP, 865481SUR, 908522SP1, 915577SP1, 918682IN41, 954MW4100, 970247INNOVA, COR359867, DR4100, FHORL4100, PEMBROKE4100, RADNETXV1, RHD4100, 480512SP, 8458584100, 770736SP1, 423495M4100E, 423493I4100, 8593134100, 313343SP1, 708202VA41, 708WESTSUB4100, 509575YM4100, 80140841, 80180741, 2194654100, 4082594100, 4105434100, 4137484100, 5094744100, 5417684100, 5703214100, 5705224100, 6082634100, 7023604100, 7028804100, 219326IN41, 229228INNOV41C, 22925941V, 251435I12, 252816INNOVA, 269226IN1, 269226IN2, 269983IN41, 303839CL1, 308534ANG, 309672M4100, 312792R4100, 313876SP41, 316651INNOVA41, 317338PV3, 360754INNOVA, 401274IN41, 412623LAB1, 412623LAB3, 414328INN4100, 419251LAB1, 508383IN4100, 512528CPCL1, 541282CV2, 603650ANG1, 608263ACT, 608263XMR, 608324DAL, 610954INNOVA41, 617525IN1XX (617525IN1), 617726RF2Y6, 626359INNOVA, 650369SV5, 706291RINN, 718206LIBERTY1, 760633IR1, 773878SWGANGIO1, 801268INNOVA, 804285CATH2, 804764CATH3, 810342A41, 813558INTV, 816943SP1, 817433HSW4100, 828298VASC, 847842GS4100, 856365ANGIO, 903GS4100, 904202SP1, 904BSSP, 913317SLS4100, 952993INNOVA2, 972335LIB, 972487ANGIO1, 972566INNOVA3, 985867INNOVA2, ECXV1406E, MIRAMAR41, WCATHLAB41, 334286BSP, 757889INNOVA, 706278INNOVA1, 561747IN4, 252847PRS2, 918744JC4100, 5136864100, 850494WSP1, FWANG3217, 309343CSP1A, 309655FSP3A , 802295VALCA , 574647IN41, 480512SPUPS (480512SP), 843674VAS1, 630275AW41 (630275G41B), 0002651236AX (813745INTV), 414328INNAW (414328INN4100), 317621PV, 630275AW41B (630275G41B), 316962INNOVA41, 906485ANGIO, 4135344100, 85931341002, 423495ENDO2, 847316INNOVA41, 215537INNOVA1, 561784INSP, 4436434100, 843797TIR2, 305835IN41, 303839CL1, 318681INNOVA1, 853060196, 853060187, 06004VAS02, SK1110VA02, E001RX08, SA1005VA06, RU2278VA01, 600152VA01, RU2714VA01, RU2992VA01, RU1050VA03, RU1106VA02, RU1326VA01, 787620IN4100, 787653INNOVA, 600042VA02, NO1037VA01, NO1015VA04, BRD0411, MA1251VA01, MA1020VA01, LT4001VA02, LB1037VA01, KW1001VA03, KW1001VA04, KW1018VA04, KW1013VA01, 850060718, 850060720, 850060721, 850060722, 850060725, 850060707, YV0012, XF0150, XF0151, XF0152, XF0153, XF0154, XF0155, XF0200, YV0006, YV0007, XF0156, YV0009, XF0022, XF0149, YV0001, YV0002, YV0004, YV0010, XF0157, YV0012, B5129910, A5102671, A5163317, A5605732, A5105151, C5603903, 8.30062E+13, IL1043VA01, IE1100VA01, HU1039VA02, 00490VAS02, 01278VAS01, 10091VAS01, 00137VAS01, 00171VAS01, 00860VAS01, 00065VAS01, M2030711, M1230007, N4192927, R4211476, M4505274 , FI1015VA01, DE641223, DE188442, HC0220XR07, 407953XR01, 487692XR01, UC1129XR33, 600002VA01, CS1054VA01, 514842AINNOVA, 613548INNOVA3, 4163694100, 250370INNOVA, 306766INNOVA, 416756INNOVA, 514376INNOVA, 514934BANGIO, 519663INNOVA2, 519685INNOVA, 204787INNOVA1, 604557INNOVA, 82406070010, 82406310005, 82416030007, 82416040020, 82416100016, 82416130020, 82416130021, 82416130025, 82416220006, 82406040022, 82406120016, 82416130010, 82416130011, 82416130013, 82416140005, 82416160005, 82416160010 and 190020RX09. Recall # Z-1476-2009
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha WI, letter dated May 2008. Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON: GE Healthcare has become aware that a few customers have experienced an unusual occurrence of system lockups on Innova single plane cardiovascular X-ray imaging systems while using the image auto-archiving function. When occurring during X-Ray imaging, the acquisition fails and the user has to rest the system. To date, one patient death has been reported related to this issue.

PRODUCT: Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component, nonporous, size 4, left, sterile; Product Number: 00-5410-017-01. Knee implant used to replace the distal surface of the human femur in total knee arthroplasty surgery. For use in Non-inflammatory Degenerative Joint Disease or Inflammatory Joint Disease, deformity, moderate contracture or failed previous surgery. Product is indicated for uncemented or cemented use. Recall # Z-1477-2009
MANUFACTURER: Zimmer Inc, Warsaw, IN, by letter dated April 29, 2009. Firm initiated recall is ongoing.
REASON: The tyvek lid, which is intended to assure sterility until the device is transported to the operating room, may be missing from the inner tray.

PRODUCT: a) Philips Avalon Fetal Monitor FM20; Model Number: M2702A. Recall # Z-1478-2009; b) Philips Avalon Fetal Monitor FM30; Model Number: M2703A. Recall # Z-1479-2009
MANUFACTURER: Recalling Firm: Philips Healthcare Inc, Andover, MA, by letter dated May 15, 2009. Manufacturer: Philips Medizin System Boblingen Gmbh, Boblingen, Germany. Firm initiated recall is ongoing.
REASON: Interruption of power-up/boot sequence may cause the paper scale and recorder speed settings of the monitor to revert to factory default may lead to misinterpretation of the fetal trace by the user and to potential incorrect clinical decisions.

PRODUCT: Zimmer Steinmann Pins, 7/64 in. (2.8 mm) diameter, 9 in. (229mm) length, style 6, nonsterile, qty 6; Model Number: 00-0187-03-69. Steinmann Pins are utilized in skeletal traction for alignment and reduction of long bone fractures as guide wires in hip pinning and for fracture alignment in certain other types of fractures. Recall # Z-1481-2009
MANUFACTURER: Zimmer Inc, Warsaw, IN, by letter on May 1, 2009. Firm initiated recall is ongoing.
REASON: The package contains pins with an incorrect diameter.

PRODUCT:
1) Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 00, for cemented use only, sterile; Model Number: 6420-00-002. The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only. Recall # Z-1482-2009;
2) Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 00, for cemented use only, sterile; Model Number: 6420-01-002. The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only. Recall # 1483-2009;
3) Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 0, TIB B/PL, for cemented use only, sterile; Model Number: 6420-00-200. The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only. Recall # Z-1484-2009;
4) Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 0, TIB B/PL, for cemented use only, sterile; Model Number: 6420-01-200. The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only. Recall # Z-1485-2009
MANUFACTURER: Zimmer Inc, Warsaw, IN, by letter dated March 18, 2009. Firm initiated recall is ongoing.
REASON: The tibial spacer will not affix to the distal surface of the baseplate, as intended.

PRODUCT:
1) Arrow 4way Hi-Flo Stopcock with male luer lock, latex free used in various IV kits. Product codes: AA-00605, AA-00611, AA-00624, AA-15511, AA-15511-S, AA-15611, AA-15611-S, AA-15624, AD-04700, AD-04730, AD-09903, AD-09903-S, AD-12802, AD-12802-GH, AD-14702-EK, AD-14703, AD-14854, AD-15703, AD-16702, AD-24703, AD-24703-OB, AD-24730-OB, AD-24730-OL, AD-24802, AD-24854, AD-24854-NL, AD-25703, AD-25802-OB, AD-25855, AD-26702, AH-09801, AI-06210-IK, AI-06210-KS, AI-07155-IK, AI-07155-KS, AJ-01671, AJ-09801, AJ-09886, AJ-09903, AJ-17702-J, AK-04306-EB, AK-07801, AK-07803-AG, AK-07903, AK-09802, AK-09802-A, AK-09803, AK-09803-CDC, AK-09803-LF, AK-09803-LFSP, AK-09804, AK-09804-AG, AK-09807, AK-09807-AG, AK-09810, AK-09810-C, AK-09810-S, AK-09813-T, AK-09817-S, AK-09883-S, AK-09903-AG, AK-09903-CDC, AK-09903-J, AK-09903-JJ, AK-09903-LFSP, AK-09907-S, AK-09908-S, AK-12702-J, AK-12703-EB, AK-12703-TL, AK-14703-J, AK-15703-J, AK-15802-J, AK-15854-LA, AK-16702-J, AK-17702-J, AK-17752-J, AK-17753-J, AK-24301-J, AK-24703-J, AK-26702-J, AK-27702-J, AK-29803-CDC, AK-29903-CDC, AK-29907-CDC, AM-15703-J, AMPHIA-25703, AMPHIA-25855, ASK-01651-TRC, ASK-04301-KR, ASK-04701-KR, ASK-09800-HCA, ASK-09800-HCA1, ASK-09803-BMH, ASK-09803-PHC, ASK-09803-WBH, ASK-09810-PCMH, ASK-09817-MM, ASK-09883-UPM, ASK-09903-BMH, ASK-09903-DHM, ASK-09903-ECL, ASK-09903-ECLH, ASK-09903-HUP, ASK-09903-MGH, ASK-09903-NM, ASK-09903-PCMH, ASK-09903-PMH, ASK-09903-PMH1, ASK-09903-SB, ASK-09903-UR, ASK-09903-YNH, ASK-09907-SL, ASK-09907-SP, ASK-09907-SP1, ASK-11142-MGH1, ASK-14702-KR, ASK-14703-KR, ASK-15703-KR, ASK-17702-KR, ASK-17752-KR, ASK-18763-KR, ASK-29803-HF, ASK-29803-HF1, ASK-29803-SJH, ASK-29903-OHU, ASK-29903-UW, ASK-29903-UW1, ASK-42703-ECL, ASK-42703-ECLH, ASK-42802-ECL, ASK-42802-ECLH, ASK-45703-ECL, ASK-45703-ECLH, ASK-45854-ECL, ASK-45854-ECLH, BB-04706-C, BB-09903-AG, BB-12853, BB-22122-F, BB-22123-F, BK-22703, BL-22702, BL-22703, BP-09805, BR-10703, BR-10854, BR-12703, BR-12703-UK, BR-12853, BR-12853-E, BR-12854, BR-14853-EK, BR-15703, BR-15703-UK, BR-15853, BR-15853-E, BR-15853-SA, BR-15854, BR-22703, BR-22853, BR-22854, BR-25703, BR-25854, BR-99703, BU-25703-E, CA-09801, CA-09803, CA-09807, CA-09886, CA-09903-LF, CA-09903-S, CA-11142, CA-11142-A, CB-04730-EK, CB-25703, CB-99854, CDC-09803-1A, CDC-09903-1A, CDC-29803-1A, CDC-29903-1A, CH-09903-S, CK-01000, CK-01409, CL-07011, CL-07024, CL-07035, CL-07045, CL-07065, CL-07080, CL-07511, CL-07524, CL-07545, CL-07565, CL-07590, CL-07611, CL-07624, CL-07635, CL-07645, CL-07665, CL-07690, CL-07700, CL-07711, CL-07724, CL-07724-TB, CL-07735, CL-07745, CL-07765, CL-07780, CL-07790-R, CL-07800, CL-07811, CL-07824, CL-07835, CL-07845, CL-07865, CL-07880, CL-07900, CL-07911, CL-07924, CL-07965, CL-07980, CL-08403, CL-08403-A, CL-08503, CL-08503-A, CL-08505, CL-08603, CL-08605, CL-08605-HF, CL-08703, CL-08705-HF, CL-08803, CL-08903, CL-71165, CL-71180, CO-04730-EK, CO-14702-EK, CO-14703-EK, COE-04730-EK, COE-14702-EK, COE-14703-EK, CP-07011, CP-07511, CP-07511-P, CP-07611, CP-07611-P, CP-07711, CP-07811, CP-07911, CP-08403, CP-08503, CP-08503-A, CP-08603, CP-08603-P, CP-08703, CP-08803, CP-08903, CR-07645, CR-07745, CR-07745-NT, CS-14703-S, CS-15703-S, CS-16702-S, CS-17702-S, CS-18763-E, CS-25703-GRE, CS-25802-GRE, CT-07860, CW-08403, CW-08503, CW-08503-A, CW-08603, CW-08703, CW-08803, CW-08903, DA-04701, DA-15703, DA-15854, DG-09810-AG, DK-24702-EK, DK-24703-EK, DK-24730-EK, DM-09306, DM-09903-EB, DU-12703, DU-22703, DU-24706, DU-25142-F, EN-24702, EN-24730, ES-14702-D, ES-14854-D, EU-24702-EK, EU-24703-EK, EU-24730-EK, FL-09908-S, FO-25000, GS-09803, GU-24703, GU-24854, HA-24730-EK, HE-04730, HE-14703, HH-01000-D, HH-09803, HL-09883, HP-09903, HS-04401, HS-14853, IB-17752, IB-18763, IC-09880, IK-09600, JD-25703, KC-04701-J, KD-25703, KF-24730, KM-09886-J, LA-01000, LS-15853, LS-17702, LU-09803-S, LU-09903, MA-04301, MA-12123, MA-14703, MA-15703, MA-15855, MH-04701-C, MH-09810-VKS, MH-14703-C, MO-12123-F, MPI-17191, MPI-17326, MPI-17552, MPI-17894, MPI-17895, MPI-17895, MPI-17897, MPI-17898, MPI-17899, MPI-17900, MPI-17927, MPI-17948, MPI-18054, MS-07803, MS-07803-AG, MS-07903-AG, MS-09600, MS-22123-E, MS-24703-EK, MS-24730-EK, MS-24854-EK, MSO-01409-JHH, MSO-09801-ANW, MSO-09903-PH, MSO-11142-NMH(14), MTO-04701-KR, MTO-09801-CHA, MTO-09903-BMH, MTO-09903-UPA, MTO-09903-WHS, MTO-09907-SL, MTO-14703-OPH, MTO-15703-TCH, MTO-17702-J, MTO-17702-KR, MTO-17702-TCH, MTO-17752-J, MTO-18702-OM, MZ-09883-S, NH-09803-B, NL-09903-S, NM-07903, NM-09803-LF, NM-12853, NR-09810-S, NR-09903-S, NS-09803, NY-09903-S, OC-17702-J, OF-25703, OF-25802, OF-25854, OF-25855, OR-17702-J, OU-04301-J, OU-15703-J, OU-15703-J, OU-17702-J, OU-17702-J, OU-17752-J, OU-17752-J, PAVIA-22703, PB-09803, PB-09903, PC-09903-S, PH-09806, PM-09903-K, PM-27702, PS-09810-S, PT-12709-WC, PT-45509, PT-65509-HFC, PT-65709-WC, RB-15703, RO-15703, RO-25703, RO-25703-E, RV-09803, SA-09854, SB-09803, SB-09883-S, SB-09903-S, SB-09907-S, SC-00001, SE-09810-S, SE-15854-L, SF-09801, SG-09903, SH-17702-J, SH-17752-J, SI-09600-LJ, SI-09700-LJ, SI-09808-J, SI-09808-LJ, SI-09880-AGLJ, SI-09880-J, SI-11142, SI-11242, SJ-09883-S, SL-09807, SL-24701, SL-25853, SL-25855, SM-09802, SM-09813-T, SM-09903-S, SP-09801, SU-09903-C, SU-09903-S, SV-09804, TR-09880-C, UC-09880-S, UD-12123, UE-09800, UE-22123-F, UE-24702-ND, UE-24703-ND, UE-24730-ND, UE-25000-UC, UE-25703-FS, UE-25854-FS, UE-25855-ND, UF-14702, UF-14703, UF-22123-F, UF-24703, UF-24854, UF-25703, UF-25854, UF-25855, UF-26702, UG-14703-C, UH-15853, UK-14703-C, UK-24703, US-04730-EK, VG-09813, VI-15703, W01271, W01272, W15500, W15549, W15567, W15593, W19910, W19922, W19945, W19959, W19962, W19980, W20027, W20041, W20042, W20046, W20050, W20056, W20058, W20058-BNS, W20060, W20074, W20077, W20111, W20123, W20124, W20135, W20139, W20154, W20166, W20168, W20171, W20173, W20175, W20178, W20182, W20185, W20196, W20211, W20214, W20216, W20224, W20225, W20228, W20233, W20239, W20249, W20253, W20267, W20290, W20302, W20317, W20319, W20322, W20339, W20346, W20363, W20365, W20366, W20375, W20379, W20384, W20403, W20407, W20414, W20415, W20425, W20430, W20451, W20469, W20477, W20480, W20481, W20483, W20487, W20488, W20489, W20497, W20503, W20515, W20518, W20525, W20530, W20541, W20546, W20553, W20595, W20597, W20615, W20617, W20626, W20627, W20640, W20656, W20663, W20670, W20674, W20675, W20678, W20684, W20697, W20710, W20723, W20724, W20735, W20736, W20737, W20739, W20743, W20745, W20753, W20770, W20778, W20782, W20783, W20787, W20788, W20790, W20813, W20817, W20819, W20828, W20845, W20857, W20859, W20867, W20880, W20881, W20884, W20886, W20896, W20911, W20920, W20921, W20949, W20954, W20975, W20995, W20998, W21001, W21006, W21013, W21022, W21026, W21035, W21036, W21041, W21043, W21064, W21065, W21073, W21074, W21087, W21091, W21093, W21096, W21109, W21111, W21114, W21119, W21120, W21126, W21131, W21136, W21137, W21141, W21148, W21158, W21159, W21177, W21178, W21180, W21191, W21202, W21206, W21230, W21232, W21253, W21259, W21270, W21288, W21301, W21305, W21310, W21320, W21323, W21339, W21344, W21345, W21354, W21356, W21359, W21365, W21372, W21383, W21388, W21395, W21399, W21413, W21425, W21439, W21441, W21443, W21447, W21448, W21450, W21463, W21464, W21465, W21470, W21472, W21492, W21493, W21499, W21503, W21507, W21509, W21510, W21511, W21514, W21517, W21520, W21537, W21547, W21556, W21558, W21559, W21560, W21565, W21570, W21582, W21592, W21597, W21601, W21603, W21608, W21609, W21610, W21612, W21615, W21635, W21638, W21652, W21654, W21657, W21659, W21668, W21683, W21692, W21703, W21704, W21715, W21716, W21723, W21731, W21738, W21739, W21742, W21748, W21749, W21756, W21765, W21770, W21772, W21773, W21779, W21780, W21781, W21783, W21789, W21794, W21800, W21823, W21824, W21836, W21837, W21842, W21863, W21864, W21870, W21873, W21882, W21891, W21894, W21902, W21913, W21914, W21915, W21917, W21922, W21925, W21926, W21931, W21935, W21939, W21948, W21950, W21954, W21960, W21961-DF, W21967, W21969, W21972, W21973-DF, W21983, W21984, W21985, W21987, W21989, W21997, W22003, W22004, W22012, W22021, W22042, W22045, W22046, W22049, W22051, W22052, W22060, W22061, W22065, W22073, W22074, W22077, W22095, W22101, W22102, W22104, W22106-DF, W22108, W22113, W22121, W22138, W22140, W22141, W22149, W22151, W22155, W22156, W22158, W22167, W22174, W22185, W22186, W22188, W22192, W22196, W22214, W22218, W22219, W22220, W22227, W22232, W22233, W22237, W22238, W22239, W22240, W22241, W22242, W22243, W22245, W22247, W22248, W22249, W22250, W22254, W22255, W22256, W22266, W22268, W22269, W22271, W22272, W22280, W22281, W22285, W22295, W22306, W22315, W22317, W22318, W22322, W22325, W22329, W22335, W22337, W22339, W22342, W22344, W22345, W22346, W22347, W22350, W22351, W22352, W22353, W22354, W22355, W22357, W22358, W22360, W22361, W22363, W22366, W22367, W22371, W22374, W22378, W22382, W22383, W22384, W22391, W22394, W22396, W22397, W22398, W22399, W22402, W22403, W22405, W22407, W22408, W22413, W22416, W22417, W22420, W22429, W22433, W22437, W22440, WR-24703, YN-09903-S, ZW-27702-J. Recall # Z-1489-2009;
2) Arrow Extension sets and accessories for intravascular use. Recall # Z-1490-2009;
3) Arrow Super Arrow-Flex Percutaneous Sheath Introducers. Recall # Z-1491-2009;
4) Arrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath Introducers. Recall # Z-1492-2009;
5) Arrow Percutaneous Sheath Introducers. Recall # Z-1493-2009;
6) Arrow Single Lumen CVCs (Central Venous Catheters). Recall # Z-1494-2009;
7) Arrow Multi-Lumen CVC w/ BlueFlex Tip (Central Venous Catheter). Recall # Z-1495-2009;
8) Arrow Two-Lumen Central Venous Access (MAC). Recall # Z-1496-2009;
9) Arrow ARROWg+ard Quad-Lumen CVCs (Central Venous Catheters). Recall # Z-1497-2009;
10) Arrow ARROWg+ard Blue Plus Multi-Lumen CVCs (Central Venous Catheters). Recall # Z-1498-2009;
11) Arrow ARROWg+ard CVCs (Central Venous Catheters). Recall # Z-1499-2009;
12) Arrow Balloon and stylet temporary pacing catheter. Recall # Z-1500-2009;
13) Arrow Percutaneous Thrombolytic Device (PTD) for fistula and dialysis grafts. Recall # Z-1501-2009;
14) Arrow OTW Percutaneous Thrombolytic Device (PTD) for fistulae and dialysis grafts. Recall # Z-1502-2009;
15) Arrow Peripherally Inserted Central Catheter. Recall # Z-1503-2009
MANUFACTURER: Arrow International Inc, Reading, PA, by letter dated February 18, 2009. Firm initiated recall is ongoing.
REASON: Leakage: Material not lipid resistant may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.

PRODUCT: Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; Orthopedic manual surgical screwdriver. Recall # Z-1524-2009
MANUFACTURER: Recalling Firm: Ascension Orthopedics Inc, Austin, TX, by telephone starting April 14, 2009. Manufacturer: Normed Medizin-Technik, GmbH, Tuttlingen, Germany. Firm initiated recall is complete.
REASON: Screwdriver used with the Ascension Total Foot System not manufactured to specification, resulting in the driver not properly engaging and/or stripping the screws making it difficult to properly seat the screws during surgery.

PRPRODUCT: Stryker Xia Dual Anterior Staple; Non Sterile; Catalog number 03820115; Single use device sterilized prior to use. For anterior/anterolateral and posterior noncervical pedicle and non-pedicle fixation for the following: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, psudoartrosis, and failed previous fusion. Recall # Z-1525-2009
MANUFACTURER: Recalling Firm: Stryker Spine, Allendale, NJ, by letters on April 13, 2007. Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is complete.
REASON: Labeling Issue: The large Xia Anterior Staple was laser marked with an “S”, indicating small.

PRODUCT:
1) Biomet OSS FINN Proximal Femoral Trial 7 cm resection/right, stainless steel; REF 32-472086. A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery. Recall # Z-1526-2009;
2) Biomet OSS FINN Proximal Femoral Trial 7 cm resection/left, stainless steel; REF 32-472087. A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery. Recall # Z-1527-2009;
3) Biomet OSS Letson Proximal Femoral Trial 7 cm resection/right, stainless steel; REF 32-472088. A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery. Recall # Z-1528-2009;
4) Biomet OSS Letson Proximal Femoral Trial 7 cm resection/left, stainless steel; REF 32-472089. A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery. Recall # Z-1529-2009;
5) Biomet OSS Elliptical Proximal Femoral Trial 7 cm, right provisional, stainless steel; REF 32-472124. A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery. Recall # Z-1530-2009;
6) Biomet OSS Elliptical Proximal Femoral Trial 7 cm left provisional, stainless steel; REF 32-472125. A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery. Recall # Z-1531-2009;
MANUFACTURER: Biomet, Inc, Warsaw, IN, by letter dated May 19, 2009. Firm initiated recall is ongoing.
REASON: The retaining ring may fall out of the instrument during surgery.

PRODUCT:
1) TransFx External Fixation System Drill Bit, Quick Connect, 2.0 mm diameter, 125 mm length, nonsterile; REF 4450-54. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities. Recall # Z-1532-2009;
2) TransFx External Fixation System Drill Bit, Quick Connect, 2.5 mm diameter, 180 mm length, nonsterile; REF 4450-56. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities. Recall # Z-1533-2009;
3) TransFx External Fixation System Drill Bit, Quick Connect, 3.0 mm diameter, 180 mm length, nonsterile; REF 4450-58. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities. Recall # Z-1534-2009;
4) TransFx External Fixation System Drill Bit, Quick Connect, 3.5 mm diameter, 195 mm length, nonsterile; REF 4450-61. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities. Recall # Z-1535-2009;
5) TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 195 mm length, nonsterile; REF 4450-63. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities. Recall # Z-1536-2009;
6) TransFx External Fixation System Drill Bit, Quick Connect, 4.5 mm diameter, 230 mm length, nonsterile; REF 4450-65. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities. Recall # Z-1537-2009;
7) TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 230 mm length, nonsterile; REF 4450-67. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities. Recall # Z-1538-2009
MANUFACTURER: Recalling Firm: Zimmer Inc, Warsaw, IN, by letter dated May 1, 2009. Manufacturer: Immedica, Inc, Chatham, NJ. Firm initiated recall is ongoing.
REASON: Drill tip is out of specifications, reducing the efficiency of drilling action.p>

PRPRODUCT: Bard StartLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124. Recall # Z-1539-2009
MANUFACTURER: C.R. Barb, Inc, Urological Division, Covington, GA, by letter on April 2, 2009. Manufacturer: Davol Surgical Innovations S.A. de C.V., Ciudad Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON: The affected units may contain extension sets with the microbore tubing instead of extension sets with the macrobore tubing.

PRODUCT: GE Centricity PACS (Picture Archiving and Communication System) software; The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment. Recall # Z-1549-2009r> MANUFACTURER: GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated April 2, 2009. Firm initiated recall is ongoing.
REASON: There is a potential safety issue associated with the use of GE Centricity PACS software related to configuration of DICOM query retrieval with rejected images.

PRODUCT:
11) GE Signa Ovation 0.35 T MR System. The Signa Ovation System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. Model Numbers: 2276937, 2377062-8, 2377062-5 and unknown. Recall # Z-1556-2009;2) GE Signa OpenSpeed 0.7T MR System. The 0.7T Signa OpenSpeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. Product Numbers: 2138300-30, 2377062-5, 2377062-30 and unknown; Recall # Z-1557-2009
MANUFACTURER: GE Medical Systems, LLC, Waukesha WI, by letter dated April 16, 2009. Manufacturer: Yokogawa Medical Systems, Ltd., Hino-Shi, Tokyo, Japan. Firm initiated recall is ongoing.
REASON: GE Healthcare has identified a potential safety issue with the Signa OpenSpeed and Signa Ovation MR Scanner tables that may impact patient safety. The table may begin lowering on its own while a patient is on the table. If this occurs while the table is in the magnet bore, the table may tilt and could result in patient injury. The patient's head or feet depending on patient orientation may hit the top of the magnet bore and/or the patient may fall from the table.

PRODUCT: Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style Catalog #: 6480-25. The SpO2 Foam Wrap Style (Single Patient Use) Sensors are intended to be used to provide for the measurement of the patient's arterial oxygen saturation and pulse rate when connected to Dixtal Medical Pulse Oximeters. Recall # Z-1559-2009
MANUFACTURER: Dixtal Medical, Inc, Wallingford, CT, by e-mail/facsimile on May 8, 2009. Firm initiated recall is ongoing.
REASON: Neonatal/Pediatric SPU Sensors may be incorrectly packaged in pouches labeled for Adult/Pediatric SPU Sensors.

PRODUCT: Sterrad 50 Sterilizer, Product Code 10050. , Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Recall # Z-1560-2009
MANUFACTURER: Advanced Sterilization Products, Irvine, CA, by letter dated January 12, 2009. Firm initiated recall is ongoing.
REASON: The capacitor in the vacuum pump component within the Sterrad 50 System could overheat and potentially create a hazardous condition inside the system, resulting in smoke and/or fire.

PRODUCT: Brilliance iCT software v2.5.0, Model 728306. The Brilliance iCT is packaged INA carton and the software is contained within the Brilliance CT scanner. The 'Brilliance iCT' is a Computed Tomography X-ray System intended to produce cross-section images of the body by computer reconstruction of x-ray transmission data taken at different Ganges and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-1582-2009
MANUFACTURER: Philips Medical Systems (Cleveland) Inc, Cleveland, OH, by letters dated December 22, 2008 and January 29, 2009. Firm initiated recall is ongoing.br> REASON: Software anomaly. An artifact may appear in brain scans and brain perfusion studies, when using 80kV and a UA, UB, or UC filter with this CT scanning device.

CLASS III
PPRODUCT: Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free; Product Number: 418000. Vacuum mixing and vacuum collection system and application system for bone cement. Recall # Z-1480-2009
MANUFACTURER: Biomet, Inc, Warsaw, IN, by letter dated April 9, 2009. Firm initiated recall is ongoing.
REASON: The package may contain two short mixing rods instead of one long and one short rod.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 1, 2009:

CLASS II

PRODUCT: Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10"). Recall # Z-1389-2009

MANUFACTURER: Welch Allyn Protocol, Inc, Beaverton, OR, by letter dated February 26, 2009. Firm initiated recall is ongoing.

REASON: Issue #1: AED 10 displayed a "Do Not Use" symbol as a result of a blown F1 fuse. Issue #2: AED 10 models that incorporate a spring connector with the speaker experienced intermittent electrical connection to the circuit board causing a loss of voice prompts.

PRODUCT: Sybaritic, Inc, SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber LED panels. Recall # Z-1423-2009

MANUFACTURER: Sybaritic, Inc, Bloomington, MN, by letter on June 18, 2008. Firm initiated recall is ongoing.

REASON: Misbranded and sale without pre-market notification.

PRODUCT: Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits. Recall # Z-1424-2009

MANUFACTURER: Recalling Firm: Medtronic Cardiovascular Revascularization & Surgical Therap, Brooklyn Park, MN, by letter dated March 5, 2009. Manufacturer: Medtronic Mexico, S. De R. L. De C.V., Tijuana, Baja California, Mexico. Firm initiated recall is ongoing.

REASON: Sterility may be compromised. Non-vented caps that connect to the 3-way stopcock attached to the transfer spike could prevent Ethylene Oxide from contacting the inside surfaces of the stopcock during sterilization, leading to a potentially non-sterile product. Use of the product may cause serious health consequences from potential sepsis/infection and the associated remote risk of death.

PRODUCT:
1) Arrow Embolectomy Catheters: 5 French, 2 Lumen x 40cm, Product Number: W01800, Single use, Latex Free, Rx only. The arterial embolectomy catheter is intended for use in removing arterial emboli Recall # Z-1471-2009;
2) Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, Single use, Latex Free, Rx only. The arterial embolectomy catheter is intended for use in removing arterial emboli. Recall # Z-1472-2009;
3) Arrow Embolectomy Catheters: 4 French, 2 Lumen x 40cm, Product Number: W01798, Single use, Latex Free, Rx only. The arterial embolectomy catheter is intended for use in removing arterial emboli. Recall # Z-1473-2009

MANUFACTURER: Recalling Firm: Arrow International Inc, Reading, PA, by letter dated March 25, 2009. Manufacturer: Clinical Instruments, Southbridge, MA. Firm initiated recall is ongoing.br>
REASON: The inflation arm tubing may separate from the stopcock adapter.

PRODUCT:
1) Boston Scientific Fort Guide Wire, Floppy Marker Wire, 300cm x 2 cm, REF 34949-02, for use in intravascular interventional procedures. Recall # Z-1486-2009;
2) Boston Scientific Fort Guide Wire, Floppy, 300cm x 2 cm, REF 34949-04, for use in intravascular interventional procedures. Recall # Z-1487-2009

MANUFACTURER: Recalling Firm: Boston Scientific Corp