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FDA Recalls

Attention all mdi Clients 

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 23, 2008:

CLASS II

PRODUCT: BHM Medical Infrared (IR) Hand Control System, an optional wireless control component of the Arjo Maxi Sky 600 and BHM V4 Ceiling Patient Lifts; the hand control system is composed of two components, part 700.13640.33 - IR hand control, and part 492.00038 - IR receiver board, Recall # Z-1233-2008
MANUFACTURER: Recalling Firm: Arjo, Inc., Roselle, IL, by letters dated February 15, 2008. Manufacturer: B. H. M. Medical, Inc., Magog, Canada. Firm initiated recall is ongoing.
REASON: The ceiling lift may not stop lateral movement after releasing the left (or right) action button on a ceiling lift equipped with an infrared hand control.

PRODUCT: AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System, Recall # Z-1235-2008
MANUFACTURER: American Medical Systems, Minnetonka, MN, by telephone and letters dated January 28, 2008. Firm initiated recall is ongoing.
REASON: Missing part: The units in two lots of In-Fast Ultra Transvaginal Bladder Neck Support System may contain only one bone screw, but should contain two as indicated on the labeling. Two screws are required to complete the procedure. The missing screw will result in the inability to complete the procedure as expected if there are no additional screws readily available.

PRODUCT:
Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number: 8604700; Recall # Z-1315-2008
MANUFACTURER: Recalling Firm: Draeger Medical, Inc., Telford, PA, by letter on February 7, 2008. Manufacturer: Draeger Medical AG & Co, Lubeck, Germany. Firm initiated recall is ongoing.
REASON: Detachment of Component: The chassis on some machines were manufactured out of specifications. As a result, the caster may break loose from the chassis.

PRODUCT: a) Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory pressure breathing attachment; Reference Number: P60000; Recall # Z-1379-2008; b) Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure breathing attachment; Reference Number: P63000; Recall # Z-1380-2008
MANUFACTURER: Recalling Firm: Smiths Medical ASD, Inc., Rockland, MA, by telephone on February 26, 2008 and by letter on March 4, 2008. Manufacturer: Smiths Medical ASD, Inc., Dublin, OH. Firm initiated recall is ongoing.
REASON: Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive proper amounts of air/oxygen when in need.

PRODUCT: Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood collection tube devices and in vitro diagnostic devices, Recall # Z-1917-2008
MANUFACTURER: Celsus Laboratories, Inc., Cincinnati, OH, by e-mail on April 24, 2008. Firm initiated recall is ongoing.
REASON: Contamination: The firm learned that up to 2.2% oversulfated chondroitin was found in a batch of crude heparin they received from their supplier.

PRODUCT: Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion pump; Model number: 8596SC; Packaged with catheter model number 8731 or 8731SC. Recall # Z-1308-2008
MANUFACTURER: Medtronic Neuromodulation, Minneapolis, MN, by letter on January 2008. Firm initiated recall is ongoing.
REASON: Incorrect Connector Pin: The Medtronic 8596SC Intrathecal Catheter Pump Segment Revision kits were packaged with the incorrect connector pin.

PRODUCT: Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10, Recall # Z-1372-2008
MANUFACTURER: Recalling Firm: OEC Medical Systems, Inc., Salt Lake City, UT, by letter on December 20, 2007. Manufacturer: Contour Fabricators Inc., Fenton MI. Firm initiated recall is ongoing.
REASON: No Premarket Notification: Product does not have FDA 510(k) approval for use.

PRODUCT: Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intended to be sterilized prior to use); Rx Only; The Sequoia Spinal System is designed to aid in the surgical correction of several types of spinal conditions. The product is a system of smaller devices used to provide stabilization during the development of a solid fusion mass, Recall # Z-1479-2008
MANUFACTURER: Abbott Spine, Austin, TX, by telephone on February 13, 2008 and by letter on February 20, 2008. Firm initiated recall is ongoing.
REASON: Screw Head Dissociation: The polyaxial screw head may dissociate from screw shaft during surgery. Also, the polyaxial screw driver is experiencing difficulty (broken/bent driver shafts, difficulty attaching screws to the driver and jamming of the

CLASS III

PRODUCT:
a) Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R; Recall # Z-1381-2008;b) Scorpio Total Knee Posteriorly Stabilized Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 71-4507R; Recall # Z-1382-2008
MANUFACTURER: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter on February 8, 2005. Firm initiated recall is complete.
REASON: Mislabeled: The labeling indicates a Scorpio PS Femoral Component, however, the device inside the package is actually a Scorpio CR Femoral Component.

RECALLS AND FIELD
CORRECTIONS: DEVICES

NOT LISTED FOR JULY 16, 2008

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 9, 2008:

CLASS II

PRODUCT:
1) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060603CD; Recall # Z-1246-2008;
2) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060403CD; Recall # Z-1247-2008;
3) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060803CD; Recall # Z-1248-2008;
4) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070403CD; Recall # Z-1249-2008;
5) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070603CD; Recall # Z-1250-2008;
6) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080403CD; Recall # Z-1251-2008;
7) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080401CD; Recall # Z-1252-2008;
8) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080803CD; Recall # Z-1253-2008;
9) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080601CD; Recall # Z-1254-2008;
10) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100401CD; Recall # Z-1255-2008;
11) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090603CD; Recall # Z-1256-2008;
12) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070803CD; Recall # Z-1257-2008;
13) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100601CD; Recall # Z-1258-2008;
14) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060303CD; Recall # Z-1259-2008;
15) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090401CD; Recall # Z-1260-2008;
16) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX 070303CD; Recall # Z-1261-2008;
17) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060401CD; Recall # Z-1262-2008;
18) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090601CD; Recall # Z-1263-2008;
19) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100403CD; Recall # Z-1264-2008;
20) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060601CD; Recall # Z-1265-2008;
21) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080303CD; Recall # Z-1266-2008;
22) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070401CD; Recall # Z-1267-2008;
23) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060801CD; Recall # Z-1268-2008;
24) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070203CD; Recall # Z-1269-2008;
25) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100603CD; Recall # Z-1270-2008;
26) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070601CD; Recall # Z-1271-2008;
27) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100801CD; Recall # Z-1272-2008;
28) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080301CD; Recall # Z-1273-2008;
29) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090403CD; Recall # Z-1274-2008;
30) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080801CD; Recall # Z-1275-2008;
31) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060203CD; Recall # Z-1276-2008;
32) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070801CD; Recall # Z-1277-2008;
33) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080203CD; Recall # Z-1278-2008;
34) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100303CD; Recall # Z-1279-2008;
35) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090301CD; Recall # Z-1280-2008;
36) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070301CD; Recall # Z-1281-2008;
37) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100301CD; Recall # Z-1282-2008;
38) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100903CD; Recall # Z-1283-2008;
39) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060301CD; Recall # Z-1284-2008;
40) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories;Model Number: EX100803CD; Recall # Z-1285-2008;
41) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090803CD; Recall # Z-1286-2008;
42) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090303CD; Recall # Z-1287-2008;
43) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100201CD; Recall # Z-1288-2008;
44) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090801CD; Recall # Z-1289-2008;
45) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090201CD; Recall # Z-1290-2008;
46) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060201CD; Recall # Z-1291-2008;
47) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100203CD; Recall # Z-1292-2008;
48) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090203CD; Recall # Z-1293-2008;
49) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070201CD; Recall # Z-1294-2008;
50) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100901CD; Recall # Z-1295-2008;
51) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080603CD; Recall # Z-1296-2008
MANUFACTURER: Edwards Lifesciences LLC, Irvine, CA, by letter on December 5, 2007. Firm initiated recall is ongoing.
REASON: Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised.

PRODUCT: Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D software; and Impax 5.0 and Impax 5.2 PACs with integrated MediCAD software. The softwares are used to provide digital X-ray images for pre-surgical orthopedic planning, Z-1307-2008
MANUFACTURER: AGFA Corp., Greenville, SC, by letters on February 17, 2007. Firm initiated recall is ongoing.
REASON: Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient.

CLASS III

PRODUCT: GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; Recall # Z-1314-2008
MANUFACTURER: Recalling Firm: ConvaTec, Skillman, NJ, by letter on March 7, 2008. Manufacturer: Convatec, A Bristol-Myers Squibb Co., Greensboro, NC. Firm initiated recall is ongoing.
REASON: Mislabeled: The carton label reads "For post-surgical use following a urostomy procedure." It should read "For post-surgical use following a colostomy or ileostomy procedure."

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 2, 2008:

CLASS II

PRODUCT: Access Ultra sensitive Insulin Assay Kit, Part Number 33410. The product is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of insulin levels in human serum and plasma (EDTA) using the Access Immunoassay Systems, Recall # Z-1160-2008
MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter on September 19, 2007. Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON: False negative results when used to test serum samples (as compared to plasma samples).

PRODUCT: S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and L-NETC05, Recall # Z-1161-2008
MANUFACTURER: Recalling Firm: GE Healthcare, Wauwatosa, WI, by letter on December 13, 2007. Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall is ongoing.
REASON: Failure to alarm: An active monitor could become disconnected from the unit without any notification or alarm.

PRODUCT:
a) 1 Liter Latex-Free Breathing Bags; Reservoir Bag; Vendor Part Number: 720059B, Medline Item Number: 40056; Available in various Anesthesia Circuit Kits and Complete Delivery System kits including:
1) Item Number CDS980230I, NICU-OR CDS;
2) Item Number DYNJ22691, Basin Supply Pack;
3) Item Number DYNJ24724, Spine-Crani Anesthesia Kit;
4) Item Number DYNJAAHY11, Hyperinflation System-UHS-1L;
5) Item Number DYNJAP0010, Anesthesia Circuit Ped-LF;
6) Item Number DYNJAP0011A, Pediatric Circuit-LF;
7) Item Number DYNJAP0012, Pediatric Anesthesia 40 In. CI;
8) Item Number DYNJAP0100, Pedi Breathing Circuit-LF;
9) Item Number DYNJAP0101, Anesthesia Circuit-Ped;
10) Item Number DYNJAP4012, Anesthesia Circuit Ped;
11) Item Number DYNJAP4013, Anesthesia Circuit;
12) Item Number DYNJAP4702A, Anesth Circuit Ped GS Line;
13) Item Number DYNJAP4707, Anesth Circuit 40in Ped-LF;
14) Item Number DYNJAP4722, Anes Cir 40 Ped GSEPW HYBABYH;
15) Item Number DYNJAP4729A, Circ Ped Anes Super-LF;
16) Item Number DYNJAP4730A, Circuit Pediatric Anesthesia;
17) Item Number DYNJAP4732, Anesth Circ Ped 40in 2B/V;
18) Item Number DYNJAP4740, Anesth Circ 40in Ped;
19) Item Number DYNJAP6101, Anesthesia Circuit;
20) Item Number DYNJAP6105, Anesth Circuit 60in Ped;
21) Item Number DYNJAP6106, Anes Circ Ped 60in BI GSE-LF;
22) Item Number DYNJAP6107, Anesth Circ Ped 60in ANG HME;
23) Item Number DYNJAP6108, Anesth Circuit 60in Ped;
24) Item Number DYNJAP6109, Anesth Circ Ped 60in B/V 1L-LF;
25) Item Number DYNJAP6111, Anes Cir Ped 60 GSEPW PALL FIL;
26) Item Number DYNJAP6112, Anesthesia-Peds Circuit;
27) Item Number DYNJAP6113, Circuit Pedi 60in;
28) Item Number DYNJAP6114, Anesth Circ 60in Ped;
29) Item Number DYNJAP6116, Anesth Circ 60in Ped;
30) Item Number DYNJAP6120A, Pediatric Circuit 40in LF;
31) Item Number DYNJAP6124, Anesth Circ Pedi 60in 1L GSL;
32) Item Number DYNJAP6127, Anes Circ Pedi 60in-LF;
33) Item Number DYNJAP6130, Anesth Circ Ped 60in 1L-LF;
34) Item Number DYNJAP6132A, Circuit Pediatric Anesthesia;
35) Item Number DYNJAP6133, Anesth Circuit Peds 60in-LF;
36) Item Number DYNJAP6136, Circuit Peds Anesthesia;
37) Item Number DYNJAP6137, Circuit Pediatric Anesthesia;
38) Item Number DYNJAP7217A, Anesth Circuit 72in Exp Ped BI;
39) Item Number DYNJAP7225A, Circuit Pediatric Anesthesia;
40) Item Number DYNJAP7227, Anes. 90in Exp Pedi -LF;
41) Item Number DYNJAP7233, Anes. Circuit 90in Exp Pedi-LF;
42) Item Number DYNJAP7234A, Anesthesia 72in Pediatric Exp;
43) Item Number DYNJAP7235A, Anesth Circ 72in Ped;
44) Item Number DYNJAP7236A, Anesthesia Pedi 72in;
45) Item Number DYNJAP7237, Circuit Pedi 90in EXP;
46) Item Number DYNJAP7241A, Circuit Pediatric Anesthesia;
47) Item Number DYNJAP7243B, Circ Anesth Ped 2 B/V LFree;
48) Item Number DYNJAP7246C, Circuit Pediatric Anesthesia;
49) Item Number DYNJAP7247, Anes Circ Peds 90in Exp;
50) Item Number DYNJAP7248, Anesth Circ Ped 72in Exp;
51) Item Number DYNJAP7261, Circuit Pediatric Anesthesia;
52) Item Number DYNJAP7262, Circuit Pediatric Anesthesia;
53) Item Number DYNJAP7263, Pediatric Anesthesia Circuits;
54) Item Number DYNJAP9005, Anesthesia Circuit;
55) Item Number DYNJAP9721A, Anesth Circuit Pedi HMEF LF;
56) Item Number DYNJAP9725, Pedi Expand Circuit;
57) Item Number DYNJAP9726, Anesth Circ Ped 90in;
58) Item Number DYNJAP9729, Anesth Circ 90in Exp Ped;
59) Item Number DYNJAP9730A, Circuit Pediatric 60in CORR-LF;
60) Item Number DYNJAP9732A, Circuit Pediatric Anesthesia;
61) Item Number DYNJAP9735, Peds Circuit;
62) Item Number DYNJAP9739, Circuit Pediatric Anesthesia;
63) Item Number DYNJAP9740, Circuit Pediatric Anesthesia;
64) Item Number DYNJAP9743, Circuit Pediatric Anesthesia;
65) Item Number DYNJAPF6003, Anesth Circ 60in Ped Unilimb;
66) Item Number DYNJAPF6005A, Anesth Circ 60in Uni Peds;
67) Item Number DYNJAPF6006, Anes Circ Peds 60in Uni;
68) Item Number DYNJAPF6009, Peds Anesthesia Circuit-LF;
69) Item Number DYNJAPF6011, Circuit Pediatric Anesthesia;
70) Item Number DYNJAPF6013, Circuit Pediatric Anesthesia;
71) Item Number DYNJAPF6014, Pediatric Circuit;
72) Item Number DYNJQ9160A, T&A Procedure,
Recall # Z-1162-2008;
b) 3 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720057B, Medline Item Number: 40053; Available in various Anesthesia Circuit Kits and Complete Delivery System Kits including:
1) Item Number DYNJ09422, Anesthesia Kit-LF;
2) Item Number DYNJAA9010A, Anesthesia Circuit Adult Expand;
3) Item Number 00-GS2675K, Pacemaker Kit;
4) Item Number ACC010004A, Anesthesia Drawer 6;
5) Item Number ACC010015, Anesthesia Drawer 8;
6) Item Number ACC010015A, Anesthesia Drawer 8;
7) Item Number ACC010031, Anesthesia Case Cart Drawer 6;
8) Item Number ACC010036, Anesthesia Drawer 6;
9) Item Number ACC010056, Anesthesia Cart Drawer 6;
10) Item Number CDS760048M, D&C CDS;
11) Item Number CDS760050L, Vag Hyster CDS;
12) Item Number CDS760054F, Laparoscopy CDS;
13) Item Number CDS780080J, Major Spinal CDS;
14) Item Number CDS780081G, Minor Spine CDS-LF;
15) Item Number CDS780127C, Lumbar CDS;
16) Item Number CDS780150A, Craniotomy CDS-LF;
17) Item Number CDS780151A, Spinallami-Fusion-Disk-Lumb-LF;
18) Item Number CDS840144B, Open Heart CDS;
19) Item Number CDS840270C, Carotid CDS;
20) Item Number CDS840325B, Major Vascular CDS;
21) Item Number CDS840336A, Heart-LF;
22) Item Number CDS840337A, Vascular Minor CDS-LF;
23) Item Number CDS840338A, Carotid Endarectomy CDS-LF;
24) Item Number CDS840384A, Open Heart CDS;
25) Item Number CDS840429, Arrowhead Open Heart CDS;
26) Item Number CDS840463A, Accessory Pack;
27) Item Number CDS840494, AV Fistula CDS;
28) Item Number CDS860094C, Laparoscopic Colon Resection;
29) Item Number CDS860109A, Laparoscop Bilat Tubal Lig-LF;
30) Item Number CDS860159, Major ABD Procedure CDS-Pack A;
31) Item Number CDS860159A, Major ABD Procedure CDS;
32) Item Number CDS860160A, Minor ABD Procedure CDS;
33) Item Number CDS860161, Lithotomy Major CDS;
34) Item Number CDS860161A, Lithotomy Major CDS;
35) Item Number CDS860200, Lap Appy Kit;
36) Item Number CDS860200A, Lap Appy Kit;
37) Item Number CDS860201, Lap Chole Kit;
38) Item Number CDS860201A, Lap Chole Kit;
39) Item Number CDS860202, Lap Nissen Kit;
40) Item Number CDS860202A, Lap Nissen Kit;
41) Item Number CDS920108C, Laparoscopy CDS;
42) Item Number CDS930145C, Lap Chole CDS;
43) Item Number CDS930178F, Lap Chole Somc CDS-LF;
44) Item Number CDS930183A, Lap Chole CDS-LF;
45) Item Number CDS930208B, Lap Chole CDS;
46) Item Number CDS940836B, Shoulder CDS;
47) Item Number CDS940836C, Shoulder CDS;
48) Item Number CDS940837B, Knee CDS;
49) Item Number CDS940844C, Shoulder Arthroscopy CDS;
50) Item Number CDS940859C, Arthroscopy CDS-LF;
51) Item Number CDS940896F, Arthroscopy CDS;
52) Item Number CDS940900F, Shoulder CDS;
53) Item Number CDS941067A, Knee Replacement Total-LF;
54) Item Number CDS941068B, Total Hip CDS-LF;
55) Item Number CDS941248, Extremity Ortho CDS;
56) Item Number CDS941248A, Extremity Ortho CDS;
57) Item Number CDS941325, Dr Zeegan Total Hip Encino;
58) Item Number CDS941326, Dr Zeegan Total Hip Encino;
59) Item Number CDS980153B, Basic CDS;
60) Item Number CDS980211C, O.R. Turnover Kit;
61) Item Number CDS980228K, Breast Biopsy CDS;
62) Item Number CDS980232L, Plastic CDS;
63) Item Number CDS980395, D&C/Vaginal Minor CDS-LF;
64) Item Number CDS980510D, Neuro Associates Laminectomy;
65) Item Number CDS980701, Shoulder Arthroscopy Procedure;
66) Item Number CDS980702, Knee Arthroscopy Procedure;
67) Item Number CDS980703, Extremity Procedure;
68) Item Number CDS980704, Spine Procedure;
69) Item Number CDS980749, Minor CDS;
70) Item Number CDS980794, Lithotomy CDS;
71) Item Number CDS980796, Knee Arthroscopy CDS;
72) Item Number CDS980797, Gyn Abd CDS;
73) Item Number CDS980798, C-Section CDS;
74) Item Number CDS980799, Lap Chole CDS;
75) Item Number CDS980800, Hand CDS-Dr Casey;
76) Item Number CDS980801A, Lap Gastric CDS;
77) Item Number CDS980817, Total Hip CDS;
78) Item Number CDS980818, AV Fistula CDS;
79) Item Number CDS980819, Knee Arthroscopy CDS;
80) Item Number CDS980820, Shoulder Arthroscopy CDS;
81) Item Number CDS980821, Spine CDS;
82) Item Number CDS980822, Total Knee CDS;
83) Item Number CDS980823, Hand CDS;
84) Item Number CDS980831, Gastric Bypass CDS;
85) Item Number CDS980846, Spinal CDS-LF;
86) Item Number CDS980847, Laparoscopy CDS-LF;
87) Item Number CDS980848, Universal Drape CDS;
88) Item Number CDS980849, Vascular Split Drape CDS;
89) Item Number CDS980850, Laminectomy CDS;
90) Item Number CDS980851, Head and Neck CDS;
91) Item Number CDS980904, Minor Procedure CDS;
92) Item Number CMPJ21747A, Extremity Pack;
93) Item Number CMPJY0146D, Peripheral Vascular-LF;
94) Item Number DYNJAA0063, Anesthesia Super Circuit;
95) Item Number DYNJAA0261B, Anesthesia Super Circuit-LF;
96) Item Number DYNJAA0266A, Anesth Super Circ 60in Uni;
97) Item Number DYNJAA0283B, Anesth Circ 40in Adult 3LTR-LF;
98) Item Number DYNJAA4751, Custom Circuit-Adult;
99) Item Number DYNJAA4755A, Anesthesia Circuit;
100) Item Number DYNJAA4757A, Anesth Circ 40in Adult Discnct;
101) Item Number DYNJAA4761, Anesth Circ 40in Adult;
102) Item Number DYNJAA4765C, Kit Anesthesia Accessory;
103) Item Number DYNJAA4774, Anesth Circ 40in Adult;
104) Item Number DYNJAA4776A, Circuit Adult Anesthesia;
105) Item Number DYNJAA4778, Anesth Circ Adult 40in 2BV SWI;
106) Item Number DYNJAA4791A, Circuit Adult Anesthesia;
107) Item Number DYNJAA4792, Circuit Anes Adult 40in Corr;
108) Item Number DYNJAA4798, Anes Circ 40 Ltx Free Gas Lin;
109) Item Number DYNJAA4805, Circuit Adult Anesthesia;
110) Item Number DYNJAA4808, Adult Anesthesia Circuit;
111) Item Number DYNJAA4808A, Adult Anesthesia Circuit;
112) Item Number DYNJAA4809, Circuit Adult Anesthesia-LF;
113) Item Number DYNJAA4809A, Circuit Adult Anesthesia-LF;
114) Item Number DYNJAA4811A, Circuit Adult Anesthesia;
115) Item Number DYNJAA4812, Adult Anesthesia Circuit;
116) Item Number DYNJAA4815, Adult Anesthesia Circuit;
117) Item Number DYNJAA4816, Circuit Adult Anesthesia;
118) Item Number DYNJAA4817, Circuit Adult Anesthesia;
119) Item Number DYNJAA4819, Anesthesia Circuit Adult Kit;
120) Item Number DYNJAA4820, Circuit Adult Anesthesia;
121) Item Number DYNJAA4821, Adult Anesthesia Circuit;
122) Item Number DYNJAA4828, Circuit Adult Anesthesia;
123) Item Number DYNJAA6420B, AVH Breathing Circuit-LF;
124) Item Number DYNJAA6445, Anesthesia Circuit 60 LFree;
125) Item Number DYNJAA6453, Anesth Circ Adult 60in;
126) Item Number DYNJAA6459A, Anesthesia Circuit;
127) Item Number DYNJAA6461B, Anes Circ Adult 90in EXP-LF;
128) Item Number DYNJAA6474, Circuit Adult Anesthesia;
129) Item Number DYNJAA6475, Circuit Adult Anesthesia;
130) Item Number DYNJAA6483, Circuit Adult Anesthesia;
131) Item Number DYNJAA6485A, Adult Anesthesia Circuit;
132) Item Number DYNJAA6486, Circuit Adult Anesthesia;
133) Item Number DYNJAA6489, Circuit Adult Anesthesia;
134) Item Number DYNJAA6490, Adult Anesthesia Circuit;
135) Item Number DYNJAA9010A, Anesthesia Circuit Adult Exp;
136) Item Number DYNJAA9040, Anesthesia Circuit;
137) Item Number DYNJAA9700B, Circuit Adult Anesthesia;
138) Item Number DYNJAA9714C, Nurses Kit-LF;
139) Item Number DYNJAA9717, Anesth Circuit 90 Inch HME-LF;
140) Item Number DYNJAA9724A, Anesthesia Circuit Adult;
141) Item Number DYNJAA9726, Anesthesia Circuit;
142) Item Number DYNJAA9729A, Anesth Circuit 60 HME;
143) Item Number DYNJAA9748, Anesthesia Circuit-LF;
144) Item Number DYNJAA9762, Anesth Circuit 90in EXP Adult;
145) Item Number DYNJAA9774A, Anesth Circuit Expan Swiv;
146) Item Number DYNJAA9777C, Circuit Adult Anesthesia;
147) Item Number DYNJAA9779, Anesth Circ 90in EXP Adult;
148) Item Number DYNJAA9783, Adult Anesthesia;
149) Item Number DYNJAA9814, Adult Expandable Circuit;
150) Item Number DYNJAA9819, Anesth Circuit 90in EXP-LF;
151) Item Number DYNJAA9821, Anesth Circ Adult 90in EXP;
152) Item Number DYNJAA9833, Anesth Circ 120in EXP Adult;
153) Item Number DYNJAA9834, Adult Circuit 90in Expandable;
154) Item Number DYNJAA9835B, Circuit Adult Anesthesia;
155) Item Number DYNJAA9836, Anesth Circ 90inch EXP Adult;
156) Item Number DYNJAA9837, Anesth Circ 90in EXP Adult;
157) Item Number DYNJAA9840, Circuit Adlt 90in Expand;
158) Item Number DYNJAA9842, Anesth Circ 90in EXP Adult-LF;
159) Item Number DYNJAA9844B, Circ Anesth 90in GSP 2 B/V-LF;
160) Item Number DYNJAA9845, Anesth Circuit 90in Swivel;
161) Item Number DYNJAA9864A, Circuit Adult Anesthesia;
162) Item Number DYNJAA9865, Anesthesia Circuit;
163) Item Number DYNJAA9871, Circuit Adult 90in EXP-LF;
164) Item Number DYNJAA9874, Anesthesia Circuit;
165) Item Number DYNJAA9879, Circuit Anes Adult 90in EXP-LF;
166) Item Number DYNJAA9880, Circuit Adult Anes 90in EXP;
167) Item Number DYNJAA9884, Circuit Adult 90in EXP-LF;
168) Item Number DYNJAA9888, Adult Anesthesia Circuit-LF;
169) Item Number DYNJAA9889B, Anesthesia Circuit Adult;
170) Item Number DYNJAA9890, Circuit Adult Anesthesia;
171) Item Number DYNJAA9894, Circuit Adult Anesthesia;
172) Item Number DYNJAA9898, Circuit Adult Anesthesia;
173) Item Number DYNJAA9899, Circuit Adult Anesthesia;
174) Item Number DYNJAA9900, Circuit Adult Anesthesia;
175) Item Number DYNJAA9900B, Circuit Adult Anesthesia;
176) Item Number DYNJAA9902, Circuit Adult Anesthesia;
177) Item Number DYNJAA9903, Circuit Adult Anes-SM-MRMC-RC;
178) Item Number DYNJAA9905, Circuit Adult Anesthesia;
179) Item Number DYNJAA9907, Circuit Adult Anesthesia;
180) Item Number DYNJAA9915, Circuit Adult Anesthesia;
181) Item Number DYNJAA9918, Adult Anesthesia Circuit-LF;
182) Item Number DYNJAA9919, Circuit Adult Anesthesia;
183) Item Number DYNJAA9920, Circuit Adult Anesthesia;
184) Item Number DYNJAA9921, Circuit Adult Anesthesia;
185) Item Number DYNJAA9924, Adult Anesthesia Circuit;
186) Item Number DYNJAA9925, Anesthesia Circuits;
187) Item Number DYNJAA9927, Anesthesia Super Circuit Kit;
188) Item Number DYNJAA9928, Adult Anesthesia Circuit;
189) Item Number DYNJAA9930, Adult Anesthesia Circuit;
190) Item Number DYNJAA9931, Anesthesia Circuit;
191) Item Number DYNJAAF6258A, Anesthesia Circuit;
192) Item Number DYNJAAF6262, Anesthesia Circuit Valley Hlth;
193) Item Number DYNJAAF6288A, Circuit Adult Uni 50in-LF;
194) Item Number DYNJAAF6293, Anesth Circ 72in Unilimb Adult;
195) Item Number DYNJAAF6295, Anesth Circ Adult Uni;
196) Item Number DYNJAAF6297A, Adult Anes Circuit-LF;
197) Item Number DYNJAAF6298A, Adult Anes Circuit-LF;
198) Item Number DYNJAAF6302, Adult Anesthesia Circuit;
199) Item Number DYNJAAF6324, Adult Anesthesia Circuit;
200) Item Number DYNJAAF6326, Circuit Adult Anesthesia;
201) Item Number DYNJAAF6327, Adult Anesthesia Circuit;
202) Item Number DYNJAAF6329, Circuit Adult Anesthesia;
203) Item Number DYNJAAF6330, Anesthesia Circuit Adult;
204) Item Number DYNJAAF6331, Adult Anesthesia Circuit;
205) Item Number DYNJAAF6341, Adult Anesthesia Circuit;
206) Item Number DYNJAAF6342, Circuit Adult Anesthesia;
207) Item Number DYNJAAF6343, Circuit Adult Anesthesia;
208) Item Number DYNJAAF6344, Circuit Adult Anesthesia;
209) Item Number DYNJAAF6345, Adult Anesthesia Circuit;
210) Item Number DYNJAAF6346, Anesth Circuit 72in Uni Adult;
211) Item Number DYNJAAHY13, Circuit Anes Mapleson D-LF;
212) Item Number DYNJAAHY14, Circuit Adult Uni 192in GSE;
213) Item Number DYNJT2590, Lap General CDS;
214) Item Number DYNJT2591A, Knee ACL CDS,
Recall # Z-1163-2008;
c) 2 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720058B, Medline Item Number: 40054; Available in various Anesthesia Circuit Kits and Complete Delivery System Kits including:
1) Item Number CDS980652A, Thoracic Anesthesia Pack;
2) Item Number CDS980955, Affinity Shoulder Arthroscopy;
3) Item Number CDS980956, Affinity Total Hip CDS;
4) Item Number CDS980957, Affinity Total Knee CDS;
5) Item Number DYNJAA4758B, Circuit Adult Anesthesia;
6) Item Number DYNJAA4777, Adult 40in Anesth w/HME-LF;
7) Item Number DYNJAA9796, Anes Circuit 90in EXP Adult-LF;
8) Item Number DYNJAA9847A, Adult Circuit;
9) Item Number DYNJAA9904, Circuit Adult Anesthesia;
10) Item Number DYNJAA9904A, Circuit Adult Anesthesia;
11) Item Number DYNJAA9906, Circuit Adult Anesthesia;
12) Item Number DYNJAA9933, Anesthesia Super Circuit;
13) Item Number DYNJAAF6318A, Adult Anesthesia Circuit;
14) Item Number DYNJAP4726, Pedi Circuit 40in;
15) Item Number DYNJAP4737A, Circuit Pediatric Anesthesia;
16) Item Number DYNJAP4737B, Circuit Pediatric Anesthesia;
17) Item Number DYNJAP4737C, Circuit Pediatric Anesthesia;
18) Item Number DYNJAP4744, Pediatric Anesthesia Circuit;
19) Item Number DYNJAP6138, Circuit Pediatric Anesthesia;
20) Item Number DYNJAP7258, Circuit Pediatric Anesthesia;
21) Item Number DYNJAP7259, Peds Anesthesia Circuit;
22) Item Number DYNJAPF6007, Circuit Ped Uni 60in-LF;
23) Item Number DYNJAPF6012,
Recall: Z-1164-2008
MANUFACTURER: Recalling Firm: Medline Industries, Inc., Mundelein, IL, by letter on December 5, 2007. Manufacturer: Ventlab Corp., Mocksville, NC. Firm initiated recall is ongoing.
REASON: Separation from Bushing: The breathing bag may separate from the bushing during use.

PRODUCT: Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher, Recall # Z-1167-2008
MANUFACTURER: Zoll Medical Corporation, World Wide Headquarters, Chelmsford, MA, by letter on January 14, 2008. Firm initiated recall is ongoing.
REASON: Incorrect Patient Records: Patient records that have been stored, then later transmitted or printed may not be the correct record. Records that are transmitted or printed immediately following acquisition are correct.

PRODUCT: Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation level of patients under doctor's care, Recall # Z-1188-2008
MANUFACTURER: Kentec Medical Inc., Irvin, CA, by telephone on May 18, 2007 and by letter dated May 23, 2007. Firm initiated recall is ongoing.
REASON: Incompatible components: The Finger Clip Sensors - with a Serial Number prefix of PA514, PA515, YE508, ZC502 and ZG512 - are missing an additional diode and higher resistor in its existing configuration making them inoperable when used to interface with those Ohmeda Tuffsat monitors previously re-configured by Ohmeda to include a detection circuit for diodes.

PRODUCT:
a) INTELECT INTELECT XT, Model No. 2760. Made in the USA, Recall # Z-1218-2008;
b) INTELECT LEGEND XT, Model No. 2763, Made in the USA, Recall # Z-1219-2008;
c) VECTRA GENISYS, Model No. 2761, Made in the USA, Recall # Z-1220-2008;
d) VECTRA GENISYS, Model No. 2764, Made in the USA, Recall # Z-1221-2008;
e) VECTRA TRANSPORTABLE, Model No. 2783, Made in the USA, Recall # Z-1222-2008;
f) INTELECT VET, Model No. 2756, Made in the USA, Recall # Z-1223-2008;
g) INTELECT VET, Model No. 2843, Made in the USA, Recall # Z-1224-2008;
h) INTELECT ADVANCED, Model No. 2752CC. Made in the USA, Not for sale in the U.S.A, Recall # Z-1225-2008;
i) INTELECT ADVANCED, Model No. 2755CS, Made in the USA, Not for sale in the U.S.A, Recall # Z-1226-2008;
j) INTELECT ADVANCED, Model No. 2762CC. Made in the USA, Not for sale in the U.S.A, Recall # Z-1227-2008;
k) INTELECT ADVANCED, Model No. 2765CS. Made in the USA, Not for sale in the U.S.A, Recall # Z-1228-2008;
l) INTELECT ADVANCED, Model No. 2772MC. Made in the USA, Not for sale in the U.S.A, Recall # Z-1229-2008;
m) INTELECT ADVANCED STIM, Model No. 2773MS. Made in the USA, Not for sale in the U.S.A, Recall # Z-1230-2008;
n) INTELECT MOBILE COMBO, Model No. 2778. Made in the USA, Not for sale in the U.S.A, Recall # Z-1231-2008;
o) INTELECT MOBILE, Model No. 2777. Made in the USA, Not for sale in the U.S.A, Recall # Z-1232-2008
MANUFACTURER: Chattanooga Corp Inc., Hixson, TN, by letters beginning on December 17, 2007. Firm initiated recall is ongoing.
REASON: Device malfunction: causing electric shock and burn.

PRODUCT: Solar HA Humeral Stem with Plasma Coating 7mm to 17 mm Product Catalog Number: 5351-4307, 7mm; 5351-4308, 8mm; 5351-4309, 9mm; 5351-4310, 10mm; 5351-4311, 11mm; 5351-4312, 12mm; 5351-4313, 13mm; 5351-4314, 14mm; 5351-4315, 15mm; 5351-4316, 16mm; and 5351-4317, 17mm. For use as a Shoulder Replacement. Made in USA, Recall # Z-1236-2008
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on November 28, 2007. Firm initiated recall is ongoing.
REASON: Delamination: Loosening of the titanium plasma coating on the product was observed on twelve non-distributed units.

PRODUCT: Agfa HeartLab Cardiovascular DICOMstore, Model # L9M8E. The software is used in the Agfa HeartLab Cardiovascular System, Recall # Z-1241-2008
MANUFACTURER: Recalling Firm: AGFA Corp., Greenville, SC, by telephone on June 21-26, 2007 and by letter on July 2, 2007. Manufacturer: Heartlab, Inc., Westerly, RI. Firm initiated recall is ongoing.
REASON: Misidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.

PRODUCT: Agfa HeartLab Cardiovascular Results Management Product, Model Number: L58RZ and L9MWQ, Recall # Z-1242-2008
MANUFACTURER: Recalling Firm: AGFA Corp., Greenville, SC, by telephone on July 27, 2007 to August 16, 2007 and by letter on July 27, 2007. Manufacturer: Heartlab, Inc., Westerly, RI. Firm initiated recall is ongoing.
REASON: Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured.

PRODUCT: IMPAX® 6.2.1 Network Gateway Server, License Key. Catalog # ABC. The product is used to transfer medical imaging data,Recall # Z-1306-2008
MANUFACTURER: AGFA Corp., Greenville, SC, by e-mail on December 11, 2007. Firm initiated recall is ongoing.
REASON: Failure of Data Transmission: No imaging data could be transmitted by the device, because a key value needed for data transmission was incorrectly entered in the affected units by AGFA Healthcare.

PRODUCT: Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451), Recall # Z-1606-2008
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated March 25, 2008. Firm initiated recall is ongoing.
REASON: False Results: The product may exhibit falsely elevated results. The affected lots demonstrate sporadic variability in recovery of calibrator and quality control; therefore this issue may not be readily detected upon calibration or during routine processing of Quality Control.

THERE IS NO RECALL FOR JUNE 25

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 18, 2008:

CLASS II

PRODUCT: GE LOGIQ 3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2, Recall # Z-1155-2008

MANUFACTURER: Recalling Firm: GE Healthcare Clinical Systems, Milwaukee, WI, by letter dated August 14, 2007. Manufacturer: Wipro GE Medical Systems Ltd., Whitefield, Bangalore, India. Firm initiated recall is ongoing.

REASON: Inaccurate guidelines: The BE9C is an optional, small radius Bi-planar convex probe intended for use with the LOGIQ 3 Expert system in Urology application. An attempt by the user to activate the biopsy guidelines while this probe is in use will cause incorrect guidelines to be displayed on the image. The incorrect guidelines are recognized by their orientation that is left/right reversed from the usual guideline orientation. Any attempt to use the inaccurate guidelines may result in a biopsy needle puncture at the unintended location.

PRODUCT:
a) BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450. The product is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidium IgG antibodies in human serum, Recall # Z-1156-2008;
b) BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250. The product is multiflow immunoassay intended for the quantitative detection of IgG antibodies to three (3) seperate EBV antigens in human serum. They are: 1) Epstein-Barr Virus Nuclear Antigen-1 (EBV-NA-1); 2) Viral Capsid Antigen (EBV VCA); and 3) Early Antigen diffuse (EBV EA-D), Recall # Z-1157-2008;
c) BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests – Catalog No. 665-1350. The product is a multiplex flow immunoassay intended for the qualitative detection of two (2) analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum, Recall # Z-1158-2008;
d) BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test – Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 665-1155. The product is used as an aid in the diagnosis of systemic autoimmune diseases, Recall # Z-1159-2008

MANUFACTURER: Bio-Rad Laboratories, Redmond, WA, by letters dated November 9, 2007 and telephone. Firm initiated recall is ongoing.

REASON: False negative results due to reagent packs exhibiting low signal.

PRODUCT: da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Recall # Z-1180-2008

MANUFACTURER: Intuitive Surgical, Inc., Sunnyvale, CA, by visit and letter beginning December 28, 2007. Firm initiated recall is complete.

REASON: Delay in responding: In certain circumstances, the device may not respond immediately to a user's command such as master clutch or camera control.

PRODUCT:
a) Trident Hemispherical Solid BK Acetabular Shells; 42mm to 74mm, Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis Component. Catalog number: 500-01-42A, 42 mm; 500-01-44B, 44 mm; 500-01-56C, 46mm; 500-01-48D, 48mm; 500-01-50D, 50mm; 500-01-52E, 52mm; 500-01-54D, 54mm; 500-01-56, 56mm; 500-01-58E, 58E; 500-01-60G, 60mm; 500-01-62G, 62mm; 500-01-64H, 64mm; 500-01-66H, 66mm; 500-01-68I, 68mm; 500-01-701, 70mm; 500-01-72J, 72mm; 500-01-74J, 74mm, Recall # Z-1168-2008;
b) Trident Hemispherical Acetabular Shells HA Solid BK 42mm- 74mm; Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics; Catalog Number’s: 500-11-42A, 42mm; 500-11-44B, 44mm; 500-11-46C, 46mm; 500-11-48D, 48mm; 500-11-50D, 50mm; 500-11-52E, 52mm; 500-11-54E, 54mm; 500-11-56F, 56mm; 500-11-58-F, 58mm; 500-11-60G, 60mm; 500-11-62G, 62mm; 500-11-64H, 64mm; 500-11-66H, 66mm; 500-11-681, 68mm; 500-11-701, 70mm; 500-11-72J, 72mm; 500-11-74J, 74mm, Recall # Z-1169-2008;
c) Trident Hemispherical Cluster; 42mm - 74 mm Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics; Catalog Numbers: # 502-01-42A; 42mm; 502-01-44B, 44mm; 502-01-46C, 46mm; 502-01-48D, 48mm; 502-01-50D, 50mm; 502-01-52E, 52mm; 502-01-54E, 54mm; 502-01-56F, 56mm; 502-01-58F, 58mm;, 502-01-60G, 60mm; 502-01-62G, 62mm; 502-01-64H, 64mm; 502-01-66H, 66mm; 502-01-681, 68mm; 502-01-701, 70mm;, 502-01-72J, 72mm; 502-01-74J, 74mm, Recall # Z-1170-2008;
d) Trident Hemispherical HA Cluster, 42 mm - 74mm Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Catalog Numbers: 502-11-42A, 42mm;502-11-44b, 44mm; 502-11-46C, 46mm; 502-11-48D, 48mm; 502-11-50D, 50mm; 502-11-52E, 52mm; 502-11-54E, 54mm; 502-11-56F, 56mm; 502-11-58F, 58mm; 502-11-60G, 60mm; 502-11-62G, 62mm; 502-11-64H, 64mm; 502-11-66H, 66mm; 502-11-68I, 68mm; 502-11-70I, 70mm; 502-11-72J. 72mm; 502-11-74J, 74mm, Recall # Z-1171-2008;
e) Trident Hemispherical Multi Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Catalog Numbers: 500-11-42A; 508-11-4B; 508-11-46C; 508-11-48D; 508-11-50D; 508-11-52E; 508-11-54E; 508-11-56F; 508-11-58F; 508-11-60G; 508-11-62G; 50811-64H; 508-11-66H; 508-11-68I; 508-11-70I; 598-11-72J; 508-11-74J, Recall # Z-1172-2008;
f) Trident PSL Acetabular Shells; Trident PSL HA Solid Back, 40 mm to 73 mm, hip prosthesis component, Stryker Orthopaedics, 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 2469501A 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3324601A 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3324601C 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3383201A 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3452701A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 1233601C 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 1233601E 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 1266301A 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 2469901A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 2469902A 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 3383301A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 3383301C 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 3452801A 540-11-44C TRIDENT PSL HA SOLID BACK 44mm 2468301A 540-11-44C
TRIDENT PSL HA SOLID BACK 44mm 2468301D 540-11-44C TRIDENT PSL HA SOLID BACK 44mm 2485601A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2444801A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2468401A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2468401D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2517201A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2517201D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2549701A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919001A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919001D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919002A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919002D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919003A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919103A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919104A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919104D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104101A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104102A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104102D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104102E 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 3104103A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3452501A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468501A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468502A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468503A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468503D 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483101A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483102A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483102C 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483102D 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2863001A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2863002A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2954001A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 3088702A 540-11-50E
TRIDENT PSL HA SOLID BACK 50mm 2483203A 540-11-50E TRIDENT PSL HA SOLID BACK 50mm 2825801A 540-11-50E
TRIDENT PSL HA SOLID BACK 50mm 2925906A 540-11-52E TRIDENT PSL HA SOLID BACK 52mm 2518502A 540-11-52E
TRIDENT PSL HA SOLID BACK 52mm 2713204A 540-11-52E TRIDENT PSL HA SOLID BACK 52mm 2926107A 540-11-54F
TRIDENT PSL HA SOLID BACK 54mm 2518601A 540-11-54F TRIDENT PSL HA SOLID BACK 54mm 2926001A 540-11-54F
TRIDENT PSL HA SOLID BACK 54mm 2926003A 540-11-54F TRIDENT PSL HA SOLID BACK 54mm 2926008A 540-11-56F
TRIDENT PSL HA SOLID BACK 56mm 2483301A 540-11-56F TRIDENT PSL HA SOLID BACK 56mm 2518702A 540-11-56F
TRIDENT PSL HA SOLID BACK 56mm 2518704A 540-11-56F TRIDENT PSL HA SOLID BACK 56mm 2713502A 540-11-56F
TRIDENT PSL HA SOLID BACK 56mm 3118502A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2468901A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2468902A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2484905A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2518802A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2941802A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469001A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469002A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469002C 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469003A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469003D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2483602A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2483602D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2517702A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2650601A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2826401C 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2826401D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941901A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941901D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941902A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941903A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701C 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701E 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483702A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483702C 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483702D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517601A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517602A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517602D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517603A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2650701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2910701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949801A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949802A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949802C 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949802D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2995701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2995701D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2995701E 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 3088802A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 3088802D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 3118802A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2445001A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2445001D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483901A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902C 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902E 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902F 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2503601A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2551101A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2551101D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2650801A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2650801C 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2650801D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2734501A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2911301A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2911302A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2911303A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2953801A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2953801D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 3233702A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 3233704A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 3712001A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2445101A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2445101C 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2445101D 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2445101E 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2484501A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2484501C 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2484501E 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2517401A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2551301A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2650901A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2650901C 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2910902A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2910903A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2910904A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2990801A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2445201A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2445201D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2445202A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2484701A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484701C 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2484701D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484701E 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2484702A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2517501A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2517501C 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2517501D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2651001A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2651001C 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2651001D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2651001F 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2657801A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2657801C 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2657801D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911001A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911001D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911001E 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911002A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911003A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911003D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911004A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911004D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911005A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911005D 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2551901A 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2551901D 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2651101A 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2651101C 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2651101D 540-11-70J RIDENT PSL HA SOLID BACK 70mm 2911102A 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2911102C 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2911102D 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 3000001A 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 3000001D 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 5334001A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2503501A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2552201A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2552201C 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2552201D 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2651201A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2651201C 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2911201A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 3000101A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 3452901A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 3452901D, Recall # Z-1173-2008;
g) Trident PSL HA Cluster: 40 mm to 72 mm, hip prosthesis component,
540-11-40A TRIDENT PSL HA SOLID BACK 40mm 2469501A 540-11-40A
TRIDENT PSL HA SOLID BACK 40mm 3324601A 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3324601C 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3383201A 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3452701A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 1233601C 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 1233601E 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 1266301A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 2469901A 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 2469902A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 3383301A 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 3383301C 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 3452801A 540-11-44C
TRIDENT PSL HA SOLID BACK 44mm 2468301A 540-11-44C TRIDENT PSL HA SOLID BACK 44mm 2468301D 540-11-44C
TRIDENT PSL HA SOLID BACK 44mm 2485601A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2444801A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2468401A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2468401D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2517201A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2517201D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2549701A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919001A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919001D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919002A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919002D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919003A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919103A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919104A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919104D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104101A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104102A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104102D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104102E 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104103A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 3452501A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468501A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468502A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468503A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468503D 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483101A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483102A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483102C 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483102D 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2863001A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2863002A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2954001A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 3088702A 540-11-50E TRIDENT PSL HA SOLID BACK 50mm 2483203A 540-11-50E
TRIDENT PSL HA SOLID BACK 50mm 2825801A 540-11-50E TRIDENT PSL HA SOLID BACK 50mm 2925906A 540-11-52E
TRIDENT PSL HA SOLID BACK 52mm 2518502A 540-11-52E TRIDENT PSL HA SOLID BACK 52mm 2713204A 540-11-52E
TRIDENT PSL HA SOLID BACK 52mm 2926107A 540-11-54F TRIDENT PSL HA SOLID BACK 54mm 2518601A 540-11-54F
TRIDENT PSL HA SOLID BACK 54mm 2926001A 540-11-54F TRIDENT PSL HA SOLID BACK 54mm 2926003A 540-11-54F
TRIDENT PSL HA SOLID BACK 54mm 2926008A 540-11-56F TRIDENT PSL HA SOLID BACK 56mm 2483301A 540-11-56F
TRIDENT PSL HA SOLID BACK 56mm 2518702A 540-11-56F TRIDENT PSL HA SOLID BACK 56mm 2518704A 540-11-56F
TRIDENT PSL HA SOLID BACK 56mm 2713502A 540-11-56F TRIDENT PSL HA SOLID BACK 56mm 3118502A 540-11-58G
TRIDENT PSL HA SOLID BACK 58mm 2468901A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2468902A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2484905A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2518802A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2941802A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469001A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469002A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469002C 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469003A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469003D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2483602A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2483602D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2517702A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2650601A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2826401C 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2826401D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941901A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941901D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941902A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941903A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701C 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701E 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483702A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483702C 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483702D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517601A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517602A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517602D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517603A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2650701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2910701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949801A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949802A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949802C 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949802D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2995701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2995701D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2995701E 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 3088802A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 3088802D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 3118802A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2445001A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2445001D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483901A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902C 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902E 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2483902F 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2503601A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2551101A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2551101D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2650801A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2650801C 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2650801D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2734501A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2911301A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2911302A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2911303A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2953801A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2953801D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 3233702A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 3233704A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 3712001A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2445101A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2445101C 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2445101D 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2445101E 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2484501A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2484501C 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2484501E 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2517401A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2551301A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2650901A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2650901C 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2910902A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2910903A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2910904A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2990801A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2445201A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2445201D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2445202A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484701A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2484701C 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484701D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2484701E 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484702A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2517501A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2517501C 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2517501D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2651001A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2651001C 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2651001D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2651001F 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2657801A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2657801C 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2657801D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911001A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911001D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911001E 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911002A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911003A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911003D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911004A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911004D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911005A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911005D 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2551901A 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2551901D 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2651101A 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2651101C 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2651101D 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2911102A 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2911102C 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2911102D 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 3000001A 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 3000001D 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 5334001A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2503501A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2552201A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2552201C 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2552201D 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2651201A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2651201C 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2911201A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 3000101A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 3452901A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 3452901D
Recall # Z-1174-2008

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on January 21, 2008, February 4, and February 28, 2008.

Manufacturer: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.

REASON: Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 11, 2008:

CLASS II

PRODUCT: ADVIA Centaur Tnl-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Recall # Z-0580-2008

MANUFACTURER: Recalling Firm: Siemens Medical Solutions Diagnostics, Tarrytown, NY, by e-mail on June 7, 2007 and July 5, 2007. Manufacturer: Siemens Medical Solutions Diagnostics, East Walpole, MA. Firm initiated recall is ongoing.

REASON: Incorrect results: Falsely elevated Troponin values have been reported which are inconsistent with the patient's clinical picture and test negative by other Troponin assays.

PRODUCT: GE Healthcare Proteus XR/a Radiographic System, Model Number 2259976; previously marketed as the Silhouette FC, Recall # Z-0842-2008

MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha, WI, by a Field Modification Instruction and visit beginning December 2007. Manufacturer: GE Hangwei Medical Systems Co LTD, Beijing Econ & Tech Dev Zone, China. Firm initiated recall is ongoing.

REASON: The warning label that is required by 21 CFR 1020.30(j) was not on the control console of the Proteus XR/a Radiographic X-ray System, Model 2259976.

PRODUCT:
a) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, Onset Medical, Recall # Z-0905-2008;
b) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog Number: 255101; Product Number: M0062551010, Recall # Z-0906-2008;
c) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog Number: 255102; Product Number: M0062551020, Recall # Z-0907-2008;
d) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Number: 255103; Product Number: M0062551030, Recall # Z-0908-2008;
e) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog Number: 255104; Product Number: M0062551040, Recall # Z-0909-2008;
f) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator, Catalog Number: 255105; Product Number: M0062551050, Recall # Z-0910-2008;
g) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106; Product Number: M0062551060, Recall # Z-0911-2008;
h) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070, Recall # Z-0912-2008;
i) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator, Catalog Number: 255108; Product Number: M0062551080, Recall # Z-0913-2008

MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on November 29, 2007. Manufacturer: Onset Medical Corporation, Irvin, CA. Firm initiated recall is ongoing.

REASON: Sheath Removal Difficulty: Users experience difficulty in removing the sheath.

PRODUCT: AMO VISX STAR Excimer Laser System 0030-4864 Chair component of the System 0030-2381. Each chair also has a serial number, which is the same as the serial number assigned to the system it is part of, Recall # Z-1139-2008

MANUFACTURER: VISX Incorporated, a Subsidiary of AMO Inc., Santa Clara, CA, by letter on December 13, 2007. Firm initiated recall is ongoing.

REASON: Firm received two complaints (including one injury complaint) associated with the movement of the VISX chair while in the patient loading ("fully swung out" unlocked) position under an IntraLase FS laser.

PRODUCT: B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, Recall # Z-1140-2008

MANUFACTURER: Recalling Firm: B & K Medical Systems, Inc., Wilmington, MA, by letter on January 23, 2008. Manufacturer: B-K Medical A/S, Herlev, Denmark. Firm initiated recall is ongoing.

REASON: Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.

PRODUCT:
a) CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Single Use Only. Do Not Reuse. Catalog Number REF SU-20601; Recall # Z-1175-2008;
b) CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not Reuse; Catalog Number REF SU-20602; Recall # Z-1176-2008;
c) CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. Catalog Number REF SU-20802; Recall # Z-1177-2008

MANUFACTURER: California Medical Laboratories, Inc., Costa Mesa, CA, by letters on January 24, 2008. Firm initiated recall is ongoing.

REASON: Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.

PRODUCT: Presource Standard Sterile OR Scissors; straight scissors, S/B, 5.5", made in Pakistan; individually packaged in rigid styrene roll stock with a tyvek top, 50 units per case; Catalog #SSI-0003; Recall # Z-1178-2008

MANUFACTURER: Recalling Firm: Cardinal Health, McGaw Park, IL, by letter dated February 12, 2008. Manufacturer: Convertors De Mexico, S.A. De C.V., Ciudad, Juarez, Mexico. Firm initiated recall is ongoing.
REASON: The product has the potential of being non-sterile.

PRODUCT:
a) U19 Socketed Integrated Circuit ("U19 IC") on the logic board of Alaris Pump modules (aka. Medley Pump modules), Model 8100 built on or before September 8, 2005. Recall # Z-1710-2008
b) Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004: (1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (a.k.a. Medley PC Unit), (2) Alaris Pump Module (Model 8100) (a.k.a. Medley Pump Module), (3) Alaris Syringe Module (Model 8110)
(a.k.a. Medley Syringe Module), (4) Alaris PCA Module (Model 8120) (a.k.a. Medley PCA Module), (5) Alaris SpO2 Module (Models 8210) (a.k.a. Medley SpO2 Module) with Nellcor technology, and (6) Alaris SpO2 Module (Models 8220) (a.k.a. Medley SpO2 Module) with Masimo technology, Recall # Z-1711-2008;
c) U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System modules built on or before October 4, 2005: (1) Alaris Syringe module (Model 8110) (a.k.a. Medley Syringe module) (2) Alaris PCA module (Model 8120) (a.k.a. Medley PCA module), Recall # Z-1712-2008

MANUFACTURER: Recalling Firm: Cardinal Health 303 Inc., dba Alaris Products, San Diego, CA, by letter on April 10, 2008. Manufacturer: Cardinal Health 303 dba Cardinal Health, San Diego, CA. Firm initiated recall is ongoing.

REASON:
a) A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failures of the U19 Socketed Integrated Circuits (U19 IC) on the logic board of the Alaris Pump module ("Pump module"). The user will be required to replace the affected module.
b) A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors with the Alaris System due to the Inter-Unit Interface (IUI) connectors on all Alaris System modules (manufactured on or before March 26, 2004). Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004:
(1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (a.k.a. Medley PC Unit),
(2) Alaris Pump Module (Model 8100) (a.k.a. Medley Pump Module),
(3) Alaris Syringe Module (Model 8110) (a.k.a. Medley Syringe Module),
(4) Alaris PCA Module (Model 8120) (a.k.a. Medley PCA Module),
(5) Alaris SpO2 Module (Models 8210) (a.k.a. Medley SpO2 Module) with Nellcor technology, and
(6) Alaris SpO2 Module (Models 8220) (a.k.a. Medley SpO2 Module) with Masimo technology. The user will be required to replace the affected module.
c) A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failure of the U9 Socketed Integrated Circuits (U9 IC) on the display board of the Alaris Syringe Module ("Syringe module") and Alaris PCA module ("PCA module") for modules manufactured on or before October 4, 2005. The user will be required to replace the affected module.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 4, 2008:

CLASS II
PRODUCT: MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361, Recall # Z-1137-2008
MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter dated November 28, 207. Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON: Delay in Imaging: MultiDiagnost Eleva with Flat Detector x-ray system cannot perform fluoroscopy procedures while certain image file housekeeping operations are performed. Fluoroscopy cannot be performed and new exposures are not able to be acquired until the housekeeping operations are complete which may take several minutes. The loss of system availability could occur during an interventional procedure if the user conducts these housekeeping functions at that time.

CLASS III
PRODUCT: Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Recall # Z-0300-2008
MANUFACTURER: Ventana Medical Systems, Tucson, AZ, by visit on 9/6/07. Firm initiated recall is complete.
REASON: Shock hazard: Devices released prior to full testing; the configuration of the Symphony instrument during Hi pot testing procedures did not completely evaluate all components in the test loop. In specific circumstances, a shock hazard exists.

PRODUCT: Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number: SEL-00002, Recall #
Z-1546-2008
MANUFACTURER: Lorad, A Hologic, Inc., Danbury, CT, by letter on March 21, 2008. Firm initiated recall is ongoing.
REASON: Marker Misalignment: The new software version contained a magnification factor that shows CAD markers misaligned with the identified indications. The marked area is misaligned up to 2cm from the indication.

PRODUCT: EVMS (Enterprise Visual Medical System); Picture archiving and communications system; Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and 7.0.0.1., Recall # Z-1644-2008
MANUFACTURER: Emageon, Inc., Hartland, WI, by letters on January 9, and January 18, 2008. Firm initiated recall is ongoing.
REASON: Miscalculation: The calculation of the standard uptake value does not include the required calibration factor/decay correction factor. The resulting value is incorrectly calculated, which may lead to incorrect interpretation of tissue density. The calculation error exists in both the software and user guide. 

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 28, 2008

CLASS II
PRODUCT:
a) Synchron LX20 Clinical Chemistry System, Part Numbers: 466200,473032, Recall # Z-1094-2008;
b) Synchron LX20 PRO, Part Number 476100, Recall # Z-1095-2008;
c) Synchron LXi 725, Part Number A08357, Recall # Z-1096-2008;
d) UniCel DxC 600 Part Number: A10405, Recall # Z-1097-2008;
e) UniCel DxC 600i, Part Numbers: A25638, A25639, Recall # Z-1098-2008;
f) UniCel DxC 600 PRO Part Number: A10400, Recall # Z-1099-2008;
g) UniCel DxC 800 Part Number: A10411, Recall # Z-1100-2008;
h) UniCel DxC 800 PRO Part Number: A10407, Recall # Z-1101-2008
MANUFACTURER: Beckman Coulter Inc, Brea, CA, decided that Customer Notification is not needed. Replacements began April 5, 2007. Firm initiated recall is ongoing.
REASON: Intermittent Failure of Stirrer Motor-Beckman Coulter has determined that incorrect Glucose results on LX20 or DxC instruments have been related to an intermittent failure of the stirrer motor. -Stirrer motors can stall without any flags or motion errors. -If a stall occurs during a GLUm test near the time of sample inject, results may be affected. -Affected GLUm results may be high or low.

PRODUCT:
a) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 150 ml, Catalog no. A7526-150, in vitro diagnostic, Recall # Z-1110-2008;
b) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 450 ml, Catalog no. A7526-450, in vitro diagnostic, Recall # Z-1111-2008;
c) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 625 ml, Catalog no. A7526-625, in vitro diagnostic, Recall # Z-1112-2008;
d) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 504 ml, Catalog no. HA926-504, in vitro diagnostic, Recall # Z-1113-2008;
e) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 610 ml, Catalog no. HA926-610, in vitro diagnostic, Recall # Z-1114-2008;
f) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 7-A7526-R1-120, in vitro diagnostic, Recall # Z-1115-2008;
g) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 8-A7526-R1-120, in vitro diagnostic, Recall # Z-1116-2008;
h) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 305 ml, Catalog no. HA 726-305, in vitro diagnostic, Recall # Z-1117-2008
MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by letters dated December 14, 2007. Firm initiated recall is ongoing.
REASON: Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.

PRODUCT: Keeler All Pupil II Indirect Ophthalmoscope, Recall # Z-1132-2008
MANUFACTURER: Recalling Firm: Keeler Instruments, Inc., Broomall, PA, by email dated January 8, 2008. Manufacturer: Keeler Limited, Windsor, UK. Firm initiated recall is ongoing.
REASON: Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.

CLASS III
PRODUCT: Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Recall # Z-1166-2008
MANUFACTURER: Abbott Laboratories, Inc, Irving, TX, by letter dated September 26, 2007. Firm initiated recall is ongoing.
REASON: Quality Control (Out of Range)- ICT Calibrator lot number: 0505017, may contain an interferent. Not all vials within a kit are affected. The investigation determined that the interferent affects Potassium (K+) only. Use of the affected calibrator vials will generate an acceptable, but low calibration slope. When Quality Control (QC) is run to verify the calibration, K+ QC results may be below acceptable QC ranges. This interferent does not affect Sodium (Na+) and Chloride (CL-).

PRODUCT: MT-APSD-2.4 Type-@ Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable non-sterile (43.2cm) standard perforated thermoplastic head, neck and shoulder mask (2.4mm), 1 device per package, Recall # 1608-2008
MANUFACTURER: Recalling Firm: Civco Medical Instruments Inc, Kalona, IA, by letter on February 25, 2008. Manufacturer: Med Tec Inc dba CIVCO Medical Solutions, Orange City, IA. Firm initiated recall is ongoing.
REASON: Mislabeled: The mask is mislabeled with the incorrect part number but the outer packaging is correct.

PRODUCT:
a) Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-805, Recall # Z-1613-2008;
b) Fiducial Markers (0.9 x 3 mm) Soft tissue gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-809, Recall # Z-1614-2008
MANUFACTURER: Recalling Firm: Med Tec Inc dba CIVCO Medical Solutions, Orange City, IA, by telephone beginning February 28, 2008 and letter on February 29, 2008. Manufacturer: C P Medical, Portland, OR. Firm initiated recall is ongoing.
REASON: Mislabeled: Fiducial markers were incorrectly labeled. They are marked (0.9x3mm cylindrical) Soft tissue gold markers, but contain (2mm spheres) Bone gold markers.

PRODUCT: 9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Recall # Z-1616-2008
MANUFACTURER: Cardiac Science Corp, Bothell, WA, by letter on January 23, 2008. Firm initiated recall is ongoing.
REASON: Adaptor Cable Incorrectly Manufactured: The red and white connector ends of the adapter are switched. Therefore, the cable will not connect to the electrodes as indicated in the instructions.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 21, 2008

CLASS II
PRODUCT:
a) VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version), Recall # Z-0982-2008;
b) VIASYS AVEA Ventilator, Catalog numbers: 17210-03 (Italian Comprehensive Version), Recall # Z-0983-2008;
c) VIASYS AVEA Ventilator, Catalog numbers: 17310-00 (USA Comprehensive Version), Recall # Z-0984-2008;
d) VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version), Recall # Z-0985-2008;
e) VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with Compressor Version), Recall # Z-0986-2008
MANUFACTURER: Viasys Respiratory Care, Inc. dba Bird Products, Palm Springs, CA, by letters on December 18, 2007. Firm initiated recall is complete.
REASON: Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.

PRODUCT: AirLife Infant nCPAP System Driver (Catalog No: 006900;) a nasal continuous positive airway pressure device, which is part of a larger system that includes an Infant Nasal CPAP generator, fixation device and patient interface (prongs and/or mask); Firmware Version 2.02.39, Recall # Z-0987-2008
MANUFACTURER: Recalling Firm: Cardinal Health, Mc Gaw Park, IL, by letter dated January 4, 2008. Manufacturer: Cardinal Health 200 Inc dba Cardinal Health, Riverside, CA. Firm initiated recall is ongoing.
REASON: Oxygen fluctuations - The AirLife Infant Nasal CPAP System exhibited O2 fluctuations when used with low O2 flow rates when the PTO/Auxiliary port on the driver is used as a blender in administering O2 therapy via nasal cannula at flow rates of less than 4L/min.

PRODUCT: White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Recall # Z-1103-2008
MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letter on December 19, 2007. Firm initiated recall is ongoing.
REASON: Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.

PRODUCT: Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog Number 6541-4-805, Non-Sterile, Recall # Z-1105-2008
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on February 25, 2005. Firm initiated recall is complete.
REASON: Insertion/Removal Difficulties: The Baseplate Impactor/Extractor may not assemble/disassemble easily to the baseplate.

PRODUCT: Syngo US Workplace Picture Archiving and Communication System, software version 2.0, 94043. Material number: 10035829, Recall # Z-1138-2008
MANUFACTURER: Siemens Medical Solutions, Inc., Mountain View, CA, by letter dated November 2007. Firm initiated recall is ongoing.
REASON: Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.

CLASS III
PRODUCT: Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable, Recall # Z-1461-2008
MANUFACTURER: Recalling Firm: Alcon Research, Ltd, Fort Worth, TX, by fax on March 7, 2007. Manufacturer: Alcon Grieshaber AG, Schaffhausen, Switzerland. Firm initiated recall is ongoing.
REASON: Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction.

PRODUCT: AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08, Recall # Z-1462-2008
MANUFACTURER: Abbott Laboratories, Abbott Park, IL, by letter on January 21, 2008. Firm initiated recall is ongoing.
REASON: Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after installation of the revised assay file, VRTX error #0002 in Task 40 is generated and the instrument locks up when it attempts to report an AxSYM Amphetamine/Methamphetamine II patient result.

PRODUCT:
a) Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 1-ml tube, Catalog Number: R8325102, 20/pack, Recall # Z-1624-2008;
b) Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 2-ml tube, Catalog Number: R8325106, 20/pack, Recall # Z-1625-2008
MANUFACTURER: Remel Inc, Lenexa, KS, by letter on October 23, 2007. Firm initiated recall is complete.
REASON: Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 14, 2008

CLASS II
PRODUCT: Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers 9012B1011 and 9012B1001, Recall # Z-0517-2008
MANUFACTURER: Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letter in December 2007. Manufacturer: Arizona Device Mfg., Tempe AZ. Firm initiated recall is ongoing.
REASON: Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall.

PRODUCT: Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; Catalog Number: FHC-A202; Product Codes: FHC-A202-KFI3O & FHC-A202-KFI5O, Recall # Z-1118-2008
MANUFACTURER: Recalling Firm: Innovacon Inc., San Diego, CA, by letter dated October 1, 2007. Manufacturer: Abon Biopharm (Hangzhou) Co., Ltd, Hangzhou, Zhejiang, China. Firm initiated recall is ongoing.
REASON: Incorrect results; The Sure-Vue Serum/Urine hCG-STAT test, when interpreted at extended read times, may exhibit sensitivity to patient samples containing hCG at levels well below the cut-off, potentially resulting in a false positive interpretation by the user.

PRODUCT: ADVIA Centaur HAV lgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Recall # Z-1119-2008
MANUFACTURER: Siemens Medical Solutions Diagnostics, East Walpole, MA, by letter on January 12, 2008. Firm initiated recall is ongoing.
REASON: Incorrect results; False reactive specimens on the ADVIA Centaur HAV lgM assay.

PRODUCT:
a) ev3 IntraStent Biliary Stent, Model Number: S10-26, Catalog Number: 90-0648-001, Recall # Z-1120-2008;
b) ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16, Catalog Number: 90-0952-000, Recall # Z-1121-2008;
c) ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-26, Catalog Number: 90-0952-001, Recall # Z-1122-2008;
d) ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36, Catalog Number: 90-0952-002. ev3 IntraStent DoubleStrut Peripheral Stent, Model Number: S11-36, Catalog Number: 90-1075-002 (not approved within the USA), Recall # Z-1123-2008;
e) ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-16, Catalog Number: 90-1431-000. ev3 IntraStent LD DoubleStrut Large Diameter Peripheral Stent, Model Number: S15-16, Catalog Number: 90-1504-000 (not approved within USA), Recall # Z-1124-2008;
f) ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-36, Catalog Number: 90-1431-002. ev3 IntraStent LD DoubleStrut Large Diameter Peripheral Stent, Model Number: S15-36, Catalog Number: 90-1504-002 (not approved within USA), Recall # Z-1125-2008;
g) ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-16, Catalog Number: 90-2313-000 ev3 IntraStent LD Mega Large Diameter Peripheral Stent, Model Number: S17-16, Catalog Number: 90-2336-000 (not approved within USA), Recall # Z-1126-2008;
h) ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-26, Catalog Number: 90-2313-001. ev3 IntraStent LD Mega Large Diameter Peripheral Stent, Model Number: S17-26, Catalog Number: 90-2336-001 (not approved within USA), Recall # Z-1127-2008;
i) ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-36, Catalog Number: 90-2313-002. ev3 IntraStent LD Mega Large Diameter Peripheral Stent, Model Number: S17-36, Catalog Number: 90-2336-002 (not approved within USA), Recall # Z-1128-2008;
j) ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16, Catalog Number: 90-2319-000. ev3 IntraStent LD Max Large Diameter Peripheral Stent Model Number: S18-16, Catalog Number: 90-2337-000 (not approved within USA), Recall # Z-1129-2008;
k) ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-26, Catalog Number: 90-2319-001. ev3 IntraStent LD Max Large Diameter Peripheral Stent Model Number: S18-26, Catalog Number: 90-2337-001 (not approved within USA), Recall # Z-1130-2008;
l) ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-36, Catalog Number: 90-2319-002. ev3 IntraStent LD Max Large Diameter Peripheral Stent, Model Number: S18-36, Catalog Number: 90-2337-002. (not approved within USA), Recall # Z-1131-2008
MANUFACTURER: Ev3, Inc., Plymouth, MN, by letter on January 18, 2008. Firm initiated recall is ongoing.
REASON: Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.

PRODUCT: iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Recall # Z-1141-2008
MANUFACTURER: Philips Healthcare Informatics, Inc., Foster City, CA, by letter on January 21, 2008. Firm initiated recall is ongoing.
REASON: Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in the correct orientation next to the incorrect image when displayed on the monitor.

PRODUCT:
a) Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 100 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection. The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations:
  a) NDC #64253-333-35, catalog #MIH-3335: 5 mL fill in 12 mL syringe,
  b) NDC #64253-333-33, catalog #MIH-3333: 3 mL fill in 12 mL syringe,
  c) NDC #64253-333-23, catalog #MIH-3323: 3 mL fill in 6 mL syringe, Recall # Z-1543-2008;

b) Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 10 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection. The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations:
  a) NDC #64253-222-35, catalog #MIH-2235: 5 mL fill in 12 mL syringe;
  b) NDC #64253-222-33, catalog #MIH-2233: 3 mL fill in 12 mL syringe, Recall # Z-1544-2008;

c) Medefil Heparin I.V. Flush Syringe 1 unit/mL; a polypropylene luer locking syringe containing Heparin   Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 1 unit of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; The 5 mL fill in 6 mL syringes were packed 60 syringes per dispenser box,
16 boxes per shipping carton, NDC #64253-444-25, catalog #MIH-4425, Recall # Z-1545-2008

MANUFACTURER: Medefil, Inc., Glendale Heights, IL, by telephone on March 20, 2008, and by e-mail and letter on March 21, 2008 and March 24, 2008. Firm initiated recall is ongoing.
REASON: The heparin lock flush solution was manufactured from contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API). The FDA has received reports of serious injuries and/or deaths in patients administered finished heparin injectable products manufactured from heparin API containing this contaminant.

PRODUCT:
a) Tyco Healthcare Monoject Prefill 10U/rnL Heparin Lock Flush Syringe, 10ml, REF # 8881580121, Recall # Z-1594-2008;
b) Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe, 3mL REF # 8881580123, Recall # Z-1595-2008;
c) Tyco Healthcare Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL REF # 8881580125, Recall # Z-1596-2008;
d) Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 2.5mL in 3mL syringe REF # 8881580300, Recall # Z-1597-2008;
e) Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula REF # 8881581125, Recall # Z-1598-2008;
f) Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 10mL REF # 8881590121, Recall # Z-1599-2008;
g) Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 3rnL REF # 8881590123, Recall # Z-1600-2008;
h) Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe 5mL REF # 8881590125, Recall # Z-1601-2008;
i) Tyco Healthcare Monoject Prefill 100UlmL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula REF # 8881591125, Recall # Z-1602-2008
MANUFACTURER: Recalling Firm: Covidien LP, Mansfield, MA, by letter beginning March 28, 2008, through April 1, 2008. Manufacturer: Covidien, Montreal, Quebec, Canada. Firm initiated recall is ongoing.
REASON: Scientific Protein Laboratories (SPL) disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient have a heparin-like contaminant.

CLASS III
PRODUCT:
a) Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210513. The product is shipped 4 units per shipping carton. Hemodialysis kit, Recall # Z-1035-2008;
b) Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210517. The product is shipped 4 units per shipping carton. Hemodialysis kit, Recall # Z-1036-2008
MANUFACTURER: Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letter dated December 12, 2007. Manufacturer: B. Braun Carex SpA, Mirandola (MO), Italy. Firm initiated recall is ongoing.
REASON: Faulty tubing does not prime machine as intended.

PRODUCT: Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, UPC Code: 30003-020917 and UPC Code: 30003-020917, Recall # Z-1179-2008
MANUFACTURER: Recalling Firm: ConvaTec, Skillman, NJ, by letters on February 14, 2008, February 21, 2008 and April 10, 2008. Manufacturer: Nypro Dominican Republic, Inc., San Cristobal, Dominican Republic. Firm initiated recall is ongoing.
REASON: Mislabeled: The market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. The metric units (8-25mm) on the label are correct.

PRODUCT: LIASON® 25-OH Vitamin D Kit, Vitamin D test system, Model Number 310900, Recall # Z-1240-2008
MANUFACTURER: Diasorin, Inc., Stillwater, MN, by letter sent by e-mail on February 1, 2008. Firm initiated recall is ongoing.
REASON: Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high.

PRODUCT:
a) Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in (internal dia), shaft length, 90 cm, Catalog Number: 34356-446, UPN H749343564460, Sterile EO, Recall # Z-1300-2008;
b) Boston Scientific Mach 1 peripheral Guide Catheter 6F, HS Hockey Stick, .070 in (internal dia), Shaft length 55cm, Catalog Number: 19-600, UPN M001196000, Sterile EO, Recall # Z-1301-2008;
c) Boston Scientific Mach 1 peripheral Guide Catheter 6F, MP Multipurpose 90cm,.070 in (internal dia), Shaft length 90cm, Catalog Number: 19-626, UPN M001196260, Sterile EO, Recall # Z-1302-2008;
d) Boston Scientific Mach 1 peripheral Guide Catheter 6F, RDC Renal double Curve, .070 in (internal dia), Shaft length 55cm, Catalog Number: 19-666, UPN M001196660, Sterile EO, Recall # Z-1303-2008;
e) Boston Scientific Mach 1 peripheral Guide Catheter 7F, MP Multipurpose, .081 in (internal dia), Shaft length 55cm, Catalog Number: 19-723, UPN M001197230, Sterile EO, Recall # Z-1304-2008;
f) Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in (internal dia), Shaft length 55cm, Catalog Number: 19-866, UPN M001198660, Sterile EO, Recall # Z-1305-2008
MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on February 7, 2008. Manufacturer: Availmed S.A. de CV, Tijuana, Mexico. Firm initiated recall is ongoing.
REASON: Mislabeled: Seven lots/batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 7, 2008

CLASS II
PRODUCT:
a) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, Recall # Z-0905-2008;
b) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog Number: 255101; Product Number: M0062551010, Recall # Z-0906-2008;
c) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog Number: 255102; Product Number: M0062551020, Recall # Z-0907-2008;
d) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Number: 255103; Product Number: M0062551030, Recall # Z-0908-2008;
e) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog Number: 255104; Product Number: M0062551040, Recall # Z-0909-2008;
f) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator, Catalog Number: 255105; Product Number: M0062551050, Recall # Z-0910-2008;
g) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106; Product Number: M0062551060, Recall # Z-0911-2008;
h) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator, Catalog Number: 255108; Product Number: M0062551080, Recall # Z-0913-2008
MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on November 29, 2007. Manufacturer: Onset Medical Corporation, Irvine, CA. Firm initiated recall is ongoing.
REASON: Sheath Removal Difficulty: Users experience difficulty in removing the sheath.

PRODUCT:
a) Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1, Recall # Z-0971-2008;
b) Siemens Coherence Therapist system, Part No: 7339125, medical charged-particle radiation therapy system with software version 2.1, Recall # Z-0972-2008;
c) Siemens Coherence Impression Therapist system, Part No: 7341410, medical charged-particle radiation therapy system with software version 2.1, Recall # Z-0973-2008;
d) Siemens Primeview 3i medical charged-particle radiation therapy system, Part No: 7341428, with software version 3i, Recall # Z-0975-2008;
e) Siemens AG Therapist 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345411, Recall # Z-0975-2008;
f) Siemens Impression Therapist 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345429, Recall # Z-0976-2008;
g) Siemens Syngo based WS 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345437, Recall # Z-0977-2008;
h) Siemens Coherence Therapist 2.0 medical charged-particle radiation therapy system, Part No: 8139839, with software version 2.1, Recall # Z-0978-2008;
i) Siemens Primeview 3i 2.0 medical charged-particle radiation therapy system, Part No: 8139487, with software version 3i 2.0, Recall # Z-0979-2008;
j) Siemens Coherence Therapist 2.1 medical charged-particle radiation therapy system, Part No: 8147667, with software version 2, Recall # Z-0980-2008;
k) Siemens Primeview 3i 2.1 medical charged-particle radiation therapy system, Part No: 8147675, with software version 3i, Recall # Z-0981-2008
MANUFACTURER: Siemens Medical Solutions, USA, Inc., Concord, CA, by letter on October 3, 2007. Firm initiated recall is ongoing.
REASON: Image Orientation Incorrect (Image Shifts) - 1) if the reference image has been calibrated for centering and the reference image is used for patient positioning, the image will shift when the positioning tools are used. 2) This problem occurs only when non-square reference images are used, such as when images are cropped. At this point, the images will refresh, and the center of the reference image will shift.

PRODUCT: Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Recall # Z-1038-2008
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated December 21, 2007 Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON: Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition system.

PRODUCT : Seradyn QMS Vancomycin reagents, Part Number: 0373589, Recall # Z-1102-2008
MANUFACTURER: Seradyn, Inc., Indianapolis, IN, by letter dated December 20, 2007. Firm initiated recall is ongoing.
REASON: False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.

PRODUCT: GE Centricity PACS RA1000 Workstation; for diagnostic image analysis, Recall # Z-1104-2008
MANUFACTURER: GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated December 28, 2007. Firm initiated recall is ongoing.
REASON: Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [<], quotation mark ["], and apostrophe [']). This may not be evident to the end user, as the symbols only appear when the Exam Note window is open.

PRODUCT: Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Recall # Z-1106-2008
MANUFACTURER: Recalling Firm: Stryker Instruments Div. of Stryker Corporation, Portage, MI, by letter dated January 10, 2008. Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PR. Firm initiated recall is ongoing.
REASON: Sterility may be compromised, as the packaging may have channels in the packaging seal.

CLASS III
PRODUCT: Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070, Recall # Z-0912-2008
MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on November 29, 2007. Manufacturer: Onset Medical Corporation, Irvine, CA. Firm initiated recall is ongoing.
REASON: Sheath Removal Difficulty: Users experience difficulty in removing the sheath.

PRODUCT:
a) Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1, Automated differential cell counter, Part Number: 626554, Recall # Z-0958-2008;
b) Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2, Automated differential cell counter, Part Number 626553, Recall # Z-0959-2008
MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter on June 29, 2007. Manufacturer: Applied Cytometry, Sheffield, UK. Firm initiated recall is complete.
REASON: Data generation error: If the cytosettings is not refreshed or restarted during data importation, the output will include old and new data.

PRODUCT: Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Recall # Z-1037-2008
MANUFACTURER: Recalling Firm: Straumann Usa, Llc, Andover, MA, by letter on January 10, 2008. Manufacturer: Instituit Strauman, Basel, Switzerland. Firm initiated recall is ongoing.
REASON: Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diameter) and therefore, will not fit into the NC implant (3.0mm diameter) narrow connection.

CLASS II
PRODUCT: ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, a) Material Number 8245875; b) Material Number 8246951; c) Material Number 8267697; Recall Z-0661-2008
MANUFACTURER: Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on September 25, 2007. Firm initiated recall is ongoing.
REASON: Measurement Error affecting all Sequoia systems using the PAL video standard configuration and have a perspective PC installed: 1) The Sequoia" system is operating at a software revision below 8.0. 2) The Sequoia" system is configured to PAL video mode (normal for systems running at 240V 50 Hz.). 3) While using any of the Perspective" advanced display options listed above, an image or clip is then stored or saved to the system hard drive, MOD or a storage device. (This image or clip is known as a secondary capture.). 4) The secondary capture images/clips are subsequently recalled for review and measurements are made. If a measurement is taken on these secondary capture images/clips, an error can occur. The error is 0% if taken in the same axis that calibration was performed, and ranges proportionately up to 9% if the measurement is taken orthogonal or at right angles (90 degrees) to the axis that was used for calibration. If calibration was done on the horizontal axis, then vertical measurements are underestimated. If calibration was done on the vertical axis, then horizontal measurements are overestimated.

PRODUCT:
1) BIPAP AUTO, CORE PACKAGE NA, model number 1017442, filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1055-2008;
2) Filters under the following brand names: a) filter std incoming 7100 CPAP qty 1 model number 1039618; b) filter reusable PLV 2/pkg model number 35220;
c) LX UL Fine Filter 2 pack model number 1006193;
d) RP-M Series Ultrafine Filters 6 pack model number 1029331;
e) RP Vision OM Reg Filter (ASCO) model number 1007547; and f) REPL Filters package of 4 model number 929-4. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1056-2008;
3) Non-continuous ventilator accessories under the following brand names:
a) Adult ECG Electrodes model number 1016360;
b) O2 Enrichment Attachment BX 10 model number 312010;
c) O2 Enrichment Attachment Single model number 312710;
d) Alice 5, Domestic model number 1017226;
e) BIPAP Auto M.W/Humid, W/SmartCard, CA model number CA701HS;
f) BIPAP Auto M.W/Humid, W/SmartCard, US model number DS700HS;
g) BIPAP Auto M, W/SmartCard, US model number DS700S;
h) BIPAP Auto SV W/SmartCard Dom Core model number 1040716;
i) BIPAP Harmony, Intl model number 1012823;
j) BIPAP Plus M, US model number DS600;
k) BIPAP Plus M, W/Humid US model number DS600H;
l) BIPAP S/T Core Pkg NA model number 1014248;
m) BIPAP S/T North America model number 1012885;
n) BIPAP Vision Filter Pack model number 582101;
o) Duet LX/BIPAP Pro/Synch Pollen Q