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Recall Archives 26
FDA Recalls
January 2010 - June 2010
- Recalls as of
June 30, 2010
- Recalls as of
June 23, 2010
- Recalls as of
June 16, 2010
- Recalls as of
June 9, 2010
- Recalls as of June
2, 2010
- Recalls as of May
26, 2010
- Recalls as of May
19, 2010
- Recalls as of May
12, 2010
- Recalls as of May
5, 2010
- Recalls as of April 28, 2010
- Recalls as of April 21, 2010
- Recalls as of April 14, 2010
- Recalls as of April 7, 2010
- Recalls as of March 31, 2010
- Recalls as of March 24, 2010
- Recalls as of March 17, 2010
- Recalls as of March 10, 2010
- Recalls as of March 03, 2010
- Recalls as of February 24, 2010
- Recalls as of
February 17,
2010
- Recalls as of
February 10,
2010
- Recalls as of February 3, 2010
- Recalls as of January 27, 2010
- Recalls as of January 20, 2010
- Recalls as of January 13, 2010
- Recalls as of January 6, 2010
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
June 30, 2010
CLASS II
PRODUCT:
Medtronic Orthopedic Dovetail Clamp, REF 9730289. In combination with a
tera-tracker reference frame, is used by an Orthopedic surgeon to
navigate the location of an acetabular cup positioner/impactor during
hip replacement surgery. Recall # Z-0923-2010
MANUFACTURER: Medtronic Navigation, Inc., Louisville, CO, by letter on
November 3, 2009. Firm initiated recall is ongoing.
REASON: Orthopedic clamp may slip if used with non-indicated system,
resulting in possible inaccurate navigation information being displayed.
PRODUCT:
1) Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc.,
Canton, MI; Catalog # C7539-150, C7539-625, C7539-625-S, C7539-1250,
HC939-756, HC939-1340, 12-C7539-98, 8-C7539-R1-120, 8-C7539-R1-500,
8-C7539-R1-1000, 7-C7539-R1-120, 7-C7539-R1-1000, and 7-C7539-R1-500.
For the quantitative determination of creatinine in serum. For in-vitro
diagnostic use only. Recall # Z-1035-2010.2) Pointe Scientific
Creatinine Reagent R2; Catalog 3-C7539-L, 7-C7539-R2-30, 7-C7539-R2-125,
7-C7539-R2-250, 8-C7539-R2-30, 8-C7539-R2-125 and 8-7539-R2-250. For the
quantitative determination of creatinine in serum. For in-vitro
diagnostic use only. Recall # Z-1036-2010
MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by letter, dated
December 1, 2009. Firm initiated recall is ongoing.
REASON: An additional 10% picric acid was added to the R2 component
during production.
PRODUCT :
FHC micro Targeting Guideline 4000 version 1.4 (GL4K) Software, Catalog
# MT-GL4K. Int. This version of software was released in August 2009.
Recall # Z-1143-2010
MANUFACTURER: FHC, Inc., Bowdoinham, ME, by telephone and by email,
dated December 2009, beginning December 28th. Firm initiated recall is
complete.
REASON: The raster tab for the GL4K version 1.4 software may assign
incorrect depths for waveform recordings and if used to identify the
implantation target for the DBS lead, the implant may be placed in the
wrong location.
PRODUCT :
LM Aculight Corporation Perseus Pulsed Fiber Laser, Model number:
ML36L-1541. Additional Model numbers with non-defective type"A" fiber:
M22L-1540, M27L-1541, M281-1540, M30PL-1541, & M33L-1541. Pulsed laser
energy generator intended for use as an OEM component for the LiDAR/Rangefinding,
Surveillance, Mapping, and Sensing. Part Number: 35-001466-032. Recall #
Z-1170-2010
MANUFACTURER: Lockheed-Martin Aculight, Bothell, WA, by letter on May 1,
2009. Firm initiated recall is ongoing.
REASON: Defect of optical fiber - The Perseus device with type "B" fiber
has been found to emit potentially hazardous laser radiation.
PRODUCT :
ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO,
(REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5
- 5.5mm, Expiration: 2011-10-01, Rx only. Intended as a palliative
treatment of malignant neoplasms in the biliary tree. Recall #
Z-1598-2010
MANUFACTURER: Ev3, Inc., Plymouth, MN, by letter dated March 31, 2010.
Firm initiated recall is ongoing.
REASON: A lot of 120mm Protg EverFlex" Biliary Stent system may contain
a 150mm length Self-Expanding stent and two lots o 150mm Protg EverFlex"
Biliary Stent System may contain a 120 mm length Self-Expanding stent.
PRODUCT :
Eon Mini Implantable Pulse Generator (IPG). Indicated as an aid in the
management of chronic, intractable pain of the trunk and/or limbs,
including unilateral or bilateral pain. Recall # Z-1599-2010
MANUFACTURER: Advanced Neuromodulation Systems, Inc., Plano, TX, by
letter dated April 2010. Firm initiated recall is ongoing.
REASON: Due to a missed inspection step during manufacturing, a small
number of devices may experience a gradual or sudden loss of charging
capability.
PRODUCT :
Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile,
single use skin stapler, individually packaged in a thermo-formed tray
with a Tyvek lid, 5 trays per box; Made in China; catalog number FS-35W.
Designed to close incisions during a surgical procedure. Recall #
Z-1610-2010
MANUFACTURER: Recalling Firm: Cardinal Health, Mc Gaw Park, IL, by
letter dated April 1, 2010.Manufacturer: Ningbo Advan Electrical Co.
Ltd., Cixi City, China. Firm initiated recall is ongoing.
REASON: The sterility of the staplers is questionable.
PRODUCT :
1) 4.5MM Bone Tap, Modular; Intended to create a screw thread in a hole
drilled into bone to facilitate placement of a bone screw. Part Number
52-1024. Recall # Z-1611-2010;
2) 5.5MM Bone Tap, Modular; Intended to create a screw thread in a hole
drilled into bone to facilitate placement of a bone screw. Part Number
52-1025. Recall # Z-1612-2010;
3) 6.5MM Bone Tap, Modular ; Intended to create a screw thread in a hole
drilled into bone to facilitate placement of a bone screw. Part Number
52-1026. Recall # Z-1613-2010;
4) 7.5MM Bone Tap, Modular; Intended to create a screw thread in a hole
drilled into bone to facilitate placement of a bone screw. Part Number
52-1027. Recall # Z-1614-2010;
5) 8.5MM Bone Tap, Modular. Intended to create a screw thread in a hole
drilled into bone to facilitate placement of a bone screw. Part Number
52-1028. Recall # Z-1615-2010
MANUFACTURER: Recalling Firm: Blackstone Medical, Inc., Wayne, NJ, by
letter dated April 21, 2010. Manufacturer: Orthofix, Inc., McKinney, TX.
Firm initiated recall is ongoing.
REASON: Certain lots of the non-cannulated Modular Bone Taps used with
the Firebird Spinal Fixation Systems may contain a manufacturing non
conformance resulting in the taps creating a single lead screw thread
rather than the required dual lead screw thread.
PRODUCT :
1) Advance Duramer Tibial Insert, REF: Kimp-312L, Size 3 Left Medial
Pivot, Thickness 12MM, 1 each, Sterile EO. Indicated for use in knee
arthroplasty for reduction or relief of pain and/or improved knee
function in skeletally mature patients. Recall # Z-1636-2010;
2) Advance Duramer Tibial Insert, REF: Kimp-312R Size 3 Right Medial
Pivot, Thickness 12MM, 1 each, Sterile EO. Indicated for use in knee
arthroplasty for reduction or relief of pain and/or improved knee
function in skeletally mature patients. Recall # Z-1637-2010
MANUFACTURER: Wright Medical Technology, Inc., Arlington, TN, by letter
dated November 24, 2009. Firm initiated recall is complete.
REASON: The left medial pivot and right medial pivot inserts were
co-mingled.
PRODUCT :
BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Intended for use
in arthroscopic procedures. Recall # Z-1638-2010
MANUFACTURER: Becton Dickinson and Co., Waltham, MA, by telephone, fax
and e-mail beginning June 12, 2009. Firm initiated recall is complete.
REASON: Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right
instead of left.
PRODUCT :
Churchill Medical Systems Bag Access Device w/Smartsite Needleless
Injection Site, Sterile, Non pyrogenic, Latex Free Product Code:
KSA-140. Intravascular administration set. Recall # Z-1639-2010
MANUFACTURER: Churchill Medical Systems, Inc., Dover, NH, by letter
dated October 20, 2009. Firm initiated recall is complete.
REASON: Bond between the spike and needle may leak, break or detach
resulting in leakage or spillage of chemotherapeutic agents.
PRODUCT :
UniCel DxH 800 Coulter Cellular Analysis System, Part Number 629029.
Quantitative, automated hematology analyzer for in vitro diagnostic use
in screening patient populations found in clinical laboratories. Recall
# Z-1656-2010
MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter
dated March 10, 2010.Manufacturer: Beckman Coulter, Inc., Miami, FL.
Firm initiated recall is ongoing.
REASON: Issue 1: The Diagnostic procedure, Simulate-CDNR Cycle, is not
functioning properly. Impact: There is a potential for inadequate sample
preparation of samples following the use of this Diagnostic function
impacting WBC, Differential, Reticulocyte and/or NRBC results. Issue 2:
Use of the Auto Prune function causes the deletion of Quality Control
files. Impact: If the last run for a control lot is older than the
number of days set in Auto Prune (default, 30 days), all the QC runs of
that control file will be deleted.
PRODUCT :
1) Mallory Head Calcar Provisional, 34 mm replacement stem, 11 mm x 220
mm left, Sterile, REF 104773. Implant device intended for use in femoral
revision surgery. Recall # Z-1665-2010;
2) Mallory Head Calcar Provisional, 45 mm replacement stem, 13.0 x 220
mm left, Sterile, REF 104986. Implant device intended for use in femoral
revision surgery. Recall # Z-1666-2010;
3) Mallory Head Calcar Femoral, 34 mm resection/porous coated, 9mm x 170
mm stem, Sterile, REF 11-104902. Implant device intended for use in
femoral revision surgery. Recall # Z-1667-2010;
4) Mallory Head Calcar Femoral, 34 mm resection/porous coated, 13.0 x
170 mm,, Sterile, REF 11-104904. Implant device intended for use in
femoral revision surgery. Recall # Z-1668-2010;
5) Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x
170 mm stem, Sterile, REF 11-104905. Implant device intended for use in
femoral revision surgery. Recall # Z-1669-2010;
6) Mallory Head Calcar Provisional, 55 mm resection/porous coated, 17.0
mm x 260 mm left, Sterile, REF 11-104939. Implant device intended for
use in femoral revision surgery. Recall # Z-1670-2010;
7) Mallory Head Calcar Femoral, 34 mm resection/porous coated, 9.0 mm x
220 mm right stem, Sterile, REF 11-104947. Implant device intended for
use in femoral revision surgery.
Recall # Z-1671-2010;
8) Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x
220 mm right stem, Sterile, REF 11-104953. Implant device intended for
use in femoral revision surgery.
Recall # Z-1672-2010;
9) Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x
220 mm left stem, Sterile, REF 11-104954. Implant device intended for
use in femoral revision surgery.
Recall # Z-1673-2010;
10) Mallory Head Calcar Femoral, 55 mm resection/porous coated, 15.0 mm
x 220 mm right stem, Sterile, REF 11-104971. Implant device intended for
use in femoral revision surgery. Recall # Z-1674-2010;
11) Mallory Head Calcar Femoral 55 mm resection/porous coated 15.0 mm x
220 mm left stem, Sterile, REF 11-104972. Implant device intended for
use in femoral revision surgery. Recall # Z-1675-2010;
12) 17 mm Mallory Head Calcar 45 mm repl. femoral/100% porous 18.5 mm
minimum ream dia x 260 mm rt., Sterile, REF CP154591. Implant device
intended for use in femoral revision surgery. Recall # Z-1676-2010;
13) 17 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 18.5 mm
minimum ream dia. x 220 mm rt., Sterile, REF CP154593. Implant device
intended for use in femoral revision surgery. Recall # Z-1677-2010;
14) 19 mm Mallory Head Calcar 45 mm repl. femoral/100% porous 20.5 mm
minimum ream dia. x 260 mm rt., Sterile, REF CP154599. Implant device
intended for use in femoral revision surgery. Recall # Z-1678-2010;
15) 19 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 20.5 mm
minimum ream dia. x 260 mm lt.., Sterile, REF CP154604. Implant device
intended for use in femoral revision surgery. Recall # Z-1679-2010
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated March 10, 2010.
Firm initiated recall is ongoing.
REASON: The firm has found that some lots of Mallory Head Revision Stems
had flute geometry that was out of specification. The flute geometry was
too deep.
PRODUCT :
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029.
Quantitative, automated hematology analyzer for in vitro diagnostic use
in screening patient populations found in clinical laboratories. Recall
# Z-1680-2010
MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter
dated December 8, 2009.Manufacturer: Beckman Coulter, Inc., Miami, FL.
Firm initiated recall is ongoing.
REASON: The Corrective Action was initiated after Beckman Coulter
confirmed three issues related to host transmissions with the UniCel DxH
800. This information only affects instruments interfaced to a host
system.
CLASS III
PRODUCT :
1) Vycon Nutrisafe 2 syringe 5 ml, For Oral use only with Nutrisafe 2
Product Code: 1015.062M Vycon/Churchill Medical System. Recall #
Z-1203-2010;
2) Vycon Nutrisafe 2 syringe 10 ml, Syringe for connection to Nutrisafe
2. For oral use only Product Code: 1015.122M Vycon/Churchill Medical
System. Recall # Z-1204-2010
MANUFACTURER: Churchill Medical Systems, Inc., Dover, NH, by letter on
January 29, 2010. Firm initiated recall is ongoing.
REASON: Mislabeled feeding syringes : 12 ml syringe mislabeled as 10 ml.
PRODUCT :
Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3
syringes per carton; Indicated for the treatment of pain in
osteoarthritis of the knee in patients who have failed to respond
adequately to conservative non-pharmacologic therapy and simple
analgesics. Recall # Z-1635-2010
MANUFACTURER: Recalling Firm: Ferring Pharmaceuticals Inc., Parsippany,
NJ, by letter dated April 16, 2010.
Manufacturer: Bio-Technology General (Israel), Ltd., Kiryat Malchi, Beer
Tuvia, Israel. Firm initiated recall is ongoing.
REASON: Out of Specification results for molecular weight or viscosity
through the established expiration date.
PRODUCT :
1) Cepheid Xpert Flu A Panel (GXFLUPANEL-10). Indicated as an automated
multiplex real-time RT-PCR assay for use in laboratories for the in
vitro qualitative detection and differentiation of 2009 H1N1 influenza
viral RNA. Recall # Z-1651-2010
2) Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10). Indicated as an
automated multiplex real-time RT-PCR assay for use in laboratories for
the in vitro qualitative detection and differentiation of 2009 H1N1
influenza viral RNA. Recall # Z-1652-2010
MANUFACTURER: Cepheid, Sunnyvale, CA, by letter beginning February 19,
2010. Firm initiated recall is ongoing.
REASON: Firm has had an increasing number of customer complaints
regarding higher than expected Indeterminate Test Results due to
"Invalid" test reports from our system when they have been conducting
their own internal validation studies using banked frozen repository
specimens.
PRODUCT :
1) Coulter LH 500 Series System. Quantitative, automated hematology
analyzer and leukocyte differential cell counter for in vitro diagnostic
use in clinical laboratories. Product LH500 100V Part number 178832;
Product LH500 120V Part number 178833; Product LH500 240V Part Number
178834. Recall # Z-1657-2010;
2) Unicel DxH 800 Coulter Cellular Analysis System. Quantitative,
automated hematology analyzer and for in vitro diagnostic use in
screening patient populations found in clinical laboratories. Part
number: 629029. Recall # Z-1658-2010
MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter
dated February 12, 2010. Manufacturer: Beckman Coulter, Inc., Miami, FL.
Firm initiated recall is ongoing.
REASON: Issue 1: The system will substitute or omit the characters # @
[\] ' {I) when the system is configured in a language other than English
or Chinese. Example: Using the character @, a substitution in the string
'123@456' would result in '123#456' and an omission would result in
'123456' Issue 2: The system will omit the character ~ regardless of
language. Impact: There is a potential for Specimen or Patient
misidentification to occur.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
June 23, 2010
CLASS II
PRODUCT :
Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction
with UniCel Dxl Access Immunoassay Systems; Reagent Part Numbers: A78803
& 33340; Calibrator Part Number: 33345 The intended use: The Access
AccuTnI assay is a paramagnetic particle, chemiluminescent 29
immunoassay for the quantitative determination of cardiac troponin I (cTnI)
levels in human serum and plasma using the Access Immunoassay Systems to
aid in the diagnosis and treatment of myocardial infarction and cardiac
muscle damage. Cardiac Troponin I determination also aids in the risk
stratification of patients with unstable angina or non-ST segment
elevation acute coronary syndromes with respect to relative risk of
mortality, myocardial infarction, or increased probability of ischemic
events requiring urgent revascularization procedures. Recall #
Z-1318-2010
MANUFACTURER : Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter
dated February 5, 2010. Manufacturer: Beckman Coulter, Inc., Chaska, MN.
Firm initiated recall is ongoing.
REASON : The recall was initiated because Beckman Coulter has confirmed
customer reports that different results have been obtained using the
same patient samples on Access/Access 2 and UniCel Dxl platforms. Values
obtained with UniCel Dxl systems have been demonstrated to have a
positive bias compared to values obtained with Access or Access 2
systems.
PRODUCT :
Elekta Synergy XVI The intended use: Radiation therapy treatment of
malignant neoplastic diseases, as determined by a licensed medical
practitioner. Recall # Z-1411-2010
MANUFACTURER : Recalling Firm: Elekta, Inc., Norcross, GA, by letters
dated September 19, 2007, November 8, 2007, March 10, 2009, and April
29, 2009.
Manufacturer: Elekta Oncology Systems (Fmrl Philipps), Crawley, West
Sussex, UK. Firm initiated recall is ongoing.
REASON : Firm became aware of a failure in the position detection system
which could result in incorrect positioning of the detector in the
longitudinal or lateral direction.
PRODUCT :
Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192,
ANS, A St. Jude Medical Company. Product is intended to be used as an
accessory to the leads component of ANS SCS systems, functioning to
secure the lead to the fascia or interspinous/supraspinous ligament.
Recall # Z-1425-2010
MANUFACTURER : Advanced Neuromodulation Systems, Inc., Plano, TX,
verbally on February 22, 2010, and by letter dated March 8, 2010, Firm
initiated recall is ongoing.
REASON : Directions for Use of product incorrectly stated lead
compatibility information.
PRODUCT :
Unilect ECG Electrodes. Intended use: Cardiac monitoring. Model Number
4560M. Recall # Z-1431-2010
MANUFACTURER : Recalling Firm: ConvaTec, Skillman, NJ, by visit on March
9, 2010 and by letter dated March 11, 2010.
Manufacturer: Techniko Medical Ltd. Bh21 6vs, Wimborne, UK. Firm
initiated recall is ongoing.
REASON : In an emergency situation where defibrillation is necessary and
electrodes are already in use, the electrodes may malfunction and
incorrectly report lack of cardiac activity.
PRODUCT :
Instruction for Use for Symphony Double Pumping Kit; the instructions
were packaged with the following non-sterile single user accessory kits
for use with Symphony breast pumps: a) Model 67023, Harmony to Symphony
Conversion Kit; b) Model 67091, Lactina to Symphony Conversion Retail
Kit; c) Model 67099, Symphony Retail Kit; d) Model 67099-06, Symphony
Retail Kit - case of 6 kits; e) Model 67099NA, Symphony Retail Kit -
case of 6 kits for national accounts. Recall # Z-1442-2010
MANUFACTURER : Medela Inc., McHenry, IL, by letter dated March 12, 2010.
Firm initiated recall is ongoing.
REASON : The non-sterile devices were erroneously packaged with
instructions stating the devices are sterile and do not require cleaning
before first use.
PRODUCT
Peloris Rapid Tissue Processor; catalog number 26.0001 and 26.0005.
Recall # Z-1551-2010
MANUFACTURER : Recalling Firm: Leica Microsystems, Inc., Bannockburn,
IL, by letters dated February 9, 2010. Manufacturer: Leica Biosystems
Melbourne Leica BSD International Pty Ltd, Mount Waverly, Australia.
Firm initiated recall is ongoing.
REASON : Confusion during manually changing reagents, general users
running unvalidated protocols, and wax valve leakage have contributed to
tissue damage during processing, leading to rebiopsies.
PRODUCT :
Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod
System: a) Model # 40-0028-S; b) Model # 40-0029-S; and c) Model #
40-0031-S. Recall # Z-1552-2010
MANUFACTURER : 32 Acumed LLC, Hillsboro, OR, by telephone, followed by
an e-mail, and a letter on August 21, 2008. Firm initiated recall is
complete.
REASON : Products improperly handled after cleaning, prior to sanitation
and may be contaminated with inorganic material.
PRODUCT :
1) Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, a)
Models E102 and b) Models E110. Sterilized using ethylene oxide. The
product is indicated for patients who are at risk for sudden cardiac
death due to ventricular arrhythmias and may require pacing support.
COGNIS devices also provide bi-ventricular pacing. Recall # Z-1553-2010;
2) Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy
Defibrillator, Models: a) N118 and b) N119. Sterilized using ethylene
oxide. The product is indicated for patients who are at risk for sudden
cardiac death due to ventricular arrhythmias and may require pacing
support. COGNIS devices also provide bi-ventricular pacing. Recall #
Z-1554-2010; 3) Boston Scientific CONFIENT, Model E030, Implantable
Cardioverter Defibrillator (ICD). The CONFIENT Implantable Cardioverter
Defibrillator (ICDs) are designed to detect and terminate ventricular
tachycardia (VT) and ventricular fibrillation (VF) and provide
bradycardia therapy (atrial and ventricular pacing). Therapies include
both low- and high-energy shocks using either a biphasic or monophasic
waveform. Sterilized using ethylene oxide. Recall # Z-1555-2010; 4)
Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator
(CRT-D), models: a) H220, b) H225, c) H227, d) H229. The LIVIAN families
of cardiac resynchronization therapy defibrillators (CRT-Ds), provide
ventricular tachyarrhythmia and cardiac resynchronization therapies.
Ventricular tachyarrhythmia therapy is for the treatment of ventricular
tachycardia (VT) and ventricular fibrillation (VF), rhythms that are
associated with sudden cardiac death (SCD). Cardiac resynchronization
therapy is for the treatment of heart failure(HF) and uses biventricular
electrical stimulation to synchronize ventricular contractions.
Sterilized using ethylene oxide. Recall # Z-1556-2010; 5) VITALITY
Implantable Cardioverter Defibrillator. Atrial and Ventricular
Therapies. AVT, a) Model A155. VITALITY DS DR/VR, b) Models T125, c)
T135), VITALITY 2 DR/VR, d) Models T165; e) T175 and VITALITY 2 EL
DR/VR, f) Models T167 and g) T177 Implantable Cardioverter
Defibrillator. The device serial numbers are only provided for devices
subject to the retrieval. For model number with no serial numbers there
were no non-implanted devices with domestic customers. Once the required
BSC submissions and FDA reviews are completed, the BSCs distribution and
implant restrictions will no longer apply. Model T127, no serial numbers
will be retrieved. Recall # Z-1557-2010; 33 6) CONTAK RENEWAL 3 a)
Models H170, Guidant CONTAK RENEWAL 3 HE b) Models H177; c) Model H179.
Cardiac Resynchronization Therapy Defibrillator (CRT-D). These CRT-Ds
provide ventricular tachyarrhythmia and cardiac resynchronization
therapies. Ventricular tachyarrhythmia therapy is for the treatment of
ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms
that are associated with sudden cardiac death (SCD). Cardiac
resynchronization therapy is for the treatment of heart failure (HF) and
uses biventricular electrical stimulation to synchronize ventricular
contractions. Cardioversion/defibrillation therapies include a range of
low- and high-energy shocks using either a biphasic or monophasic
waveform. Sterile EO. The device serial numbers are only provided for
devices subject to the retrieval. For model number with no serial
numbers there were no non-implanted devices with domestic customers.
Once the required BSC submissions and FDA reviews are completed, the
BSCs distribution and implant restrictions will no longer apply. Model
H175, no serial numbers will be retrieved. Model H170.Recall #
Z-1558-2010; 7) VENTAK PRIZM Automatic Implantable Cardioverter
Defibrillator (AICD). DR, a) Model 1851, DR HE, b) Model 1853 and d)
Model 1858, PRIZM VR HE, c) Model 1857, PRIZM 2 VR e) Model 1860 and
PRIZM 2 DR f) Model 1861. The ICDs are designed to detect and terminate
ventricular tachycardia (VT) and ventricular fibrillation (VF) and
provide bradycardia therapy (atrial and ventricular pacing). Therapies
include both low- and high-energy shocks using either a biphasic or
monophasic waveform. Bradycardia pacing, including adaptive-rate
features is available to detect and treat bradyarrhythmias and to
support the cardiac rhythm after defibrillation therapy. The devices
denoted with DR offer dual-chamber bradycardia features (atrial and/or
ventricular pacing and sensing), and the devices denoted with VR offer
single-chamber bradycardia features (ventricular pacing and sensing).
Sterilized with gaseous ethylene oxide. The device serial numbers are
only provided for devices subject to the retrieval. For model number
with no serial numbers there were no non-implanted devices with domestic
customers. Once the required BSC submissions and FDA reviews are
completed, the BSCs distribution and implant restrictions will no longer
apply. Model 1850, 1852, 1855 and 1856, no serial numbers will be
retrieved. Recall # Z-1559-2010
MANUFACTURER : Recalling Firm: Boston Scientific CRM Corp., Saint Paul,
MN, by press release dated March 15, 2010 and March 18, 2010 and by
letter dated March 22, 2010. Manufacturer: Guidant Ireland, Clomel,
County Tipperary, Ireland. Firm initiated recall is ongoing.
REASON : 39 Boston Scientific Corporation has stopped shipment and is
retrieving unimplanted devices from US hospital shelves of all its
implantable cardioverter defibrillators (ICDs) and cardiac
resynchronization therapy defibrillators (CRT-Ds) after determining that
some manufacturing process changes were not submitted for approval to
the US Food & Drug Administration.
PRODUCT :
1) ConMed Goldline Hand Controlled With Needle Electrode, Rocker Switch,
Safety Holster and 10 FT Cable, REF 130301A, Sterile R, Assembled in
Mexico. Recall # Z-1562-2010; 2) ConMed Goldline Hand Controlled With
Blade Electrode, Tip Cleaner, Rocker Switch, Safety Holster and 10 FT
Cable, REF 130304A, Sterile R, Assembled in Mexico. Recall #
Z-1563-2010; 3) ConMed Goldline Hand Controlled With Blade Electrode,
Rocker Switch, Safety Holster and 10 FT Cable, REF 130307A, Sterile R,
Assembled in Mexico. Recall # Z-1564-2010; 4) ConMed Goldline Hand
Controlled With Blade Electrode, Rocker Switch, Safety Holster and 10 FT
Cable, REF 130319A, Sterile R, Assembled in Mexico. Recall #
Z-1565-2010; 5) ConMed Goldline Hand Controlled With Blade Electrode,
Rocker Switch, Safety Holster and 15 FT Cable, REF 130327A, Sterile R,
Assembled in Mexico. Recall # Z-1566-2010; 6) ConMed Goldline Hand
Controlled With Blade Electrode, Rocker Switch, Safety Holster and 15 FT
Cable, REF 130337A, Sterile R, Assembled in Mexico. Recall #
Z-1567-2010; 7) ConMed Goldline Hand Controlled, Rocker Switch, Safety
Holster and 10 FT Cable, Bulk, REF 130339A, Non-Sterile, Assembled in
Mexico. Recall # Z-1568-2010; 8) ConMed Goldline Hand Controlled with
UltraClean Blade Electrode, Rocker Switch, Safety Holster and 10 FT
Cable, REF 131307A, Sterile R, Assembled in Mexico. Recall #
Z-1569-2010; 9) ConMed Goldline Hand Controlled with UltraClean Blade
Electrode, Rocker Switch, Safety Holster and 10 FT Cable, REF 131319A,
Assembled in Mexico. Recall # Z-1570-2010; 10) ConMed Goldline Hand
Controlled with UltraClean Blade Electrode, Rocker Switch, Safety
Holster and 15 FT Cable, REF 131327A, Sterile R, Assembled in Mexico.
Recall # Z-1571-2010; 11) ClearVac Goldline Rocker Switch with Blade
Electrode, REF 60-6829-001A, Sterile R, Assembled in Mexico. Recall #
Z-1572-2010; 12) ClearVac Goldline Rocker Switch with UltraClean Blade
Electrode, REF 60-6829-005A, Sterile R, Assembled in Mexico. Recall #
Z-1573-2010
MANUFACTURER : Recalling Firm: ConMed Electrosurgery, Centennial, CO, by
letter on March 25, 2010. Manufacturer: Conmed Inc., Chihuahua, Mexico.
Firm initiated recall is ongoing.
REASON : Electrosurgical pencil may remain activated or self activate
after power switch is released.
PRODUCT :
An Imaging device for medical procedures, to provide surgeons or
operating room personnel the ability to capture still images and to
record video during the surgical procedures in various file formats.
Images can be transferred to external media. Product Name: SDC HD units
and SDC HDi units Model Nuumbers: 240-050-888 and 240-050-888i. Recall #
Z-1590-2010
MANUFACTURER : Stryker Endoscopy, San Jose, CA, by letter on October 23,
2009. Firm initiated recall is ongoing.
REASON : Video device is not able to assign the correct time/date stamp.
PRODUCT :
VNS Therapy Demipulse Generator, a) Model 103 and VNS Therapy Demipulse
Duo Generator, b) Model 104 VNS Therapy Programming System, c) Model 250
Version 7.0 and 7.1 Software. Recall # Z-1591-2010
MANUFACTURER : Cyberonics, Inc., Houston, TX, by letter on April 6,
2010. Firm initiated recall is ongoing.
REASON : Battery life projection is inaccurate.
PRODUCT :
41 Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical
Screw, QTY 1, Ref: HCO3250-S. Intended use: Acumed intramedullary rods
and screws are designed to provide fixation of humeral, forearm and
fibula fractures while they heal. Recall # Z-1602-2010
MANUFACTURER : Acumed LLC, Hillsboro, OR, by telephone on May 18, 2009
and by e-mails and letters on May 19, 2009. Firm initiated recall is
complete.
REASON : Mix-up of parts - Product labeled cortical bone screw actually
contains Acutract fixation screw.
PRODUCT :
Leksell GammaPlan Leksell GammaPlan is designed for use with the Leksell
Gamma Knife manufactured by Elekta Instrument AB. the Leksell GammaPlan
is intended to be used for planning the dosimetry of treatments in
stereotactic radio surgery and stereotactic radiation therapy. It
processes the inputs of the health professions (Neurosurgeons, Radiation
therapists, Radiation Physicists) such that the desired radiation does
is proved by the Leksell Gamma Knife to a precisely defined target area
within the cranium. Recall # Z-1604-2010
MANUFACTURER : Recalling Firm: Elekta, Inc., Norcross, GA, by Phase 1 -
Important Notice and Technical Note #200 058 - "Accuracy problems in
Leksell GammaPlan 8.0 image fusion", dated December 10.2007 and Field
Change Order #200 058, "Technical Note: Accuracy problems in Leksell
Gamma Plan 8.0 image fusion", dated January 7, 2008 were sent to
affected customers and all field service engineers as notification of
the problem. Manufacturer: Elekta Instrument AB, Stockholm, Sweden. Firm
initiated recall is ongoing.
REASON : The precision of the calculation used to create the fused study
in LGP 8.0 is too low and should not be used until the system is
upgraded to LGP 8.2.
PRODUCT :
Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm.
The yoke is intended to hold a flat panel monitor. Catalog number:
0682400028. Recall # Z-1605-2010
MANUFACTURER : Recalling Firm: Stryker Communications Corp., Flower
Mound, TX, letter dated April 19, 2010. Manufacturer: JLT Engineering
Products, Ltd, Bridgeport, TX. Firm initiated recall is ongoing.
REASON : Some of the pitch shafts were not properly welded which results
in the monitor becoming unlevel.
PRODUCT :
1) EXXCEL Soft Standard Wall EPTFE Vascular Graft; D: 8 mm; L: 50 cm
straight. Sterile Intended use: The Standard Wall EXXCEL and EXXCEL Soft
ePTFE Vascular Grafts are designed to repair or replace peripheral
arteries and to provide vascular access. Wall Soft ePTFE Vascular Grafts
are designed to repair or replace peripheral arteries. UPN
M002004810260. Recall # Z-1606-2010; 2) EXXCEL Soft Thin Wall EPTFE
Vascular Graft; D: 8 mm; L: 50 cm straight. Sterile Intended use: The
Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed
to repair or replace peripheral arteries and to provide vascular access.
Wall Soft ePTFE Vascular Grafts are designed to repair or replace
peripheral arteries. UPN M002004948580. Recall # Z-1607-2010
MANUFACTURER : Maquet Cardiovascular, LLC, Wayne, NJ, by letter dated
March 23, 2010. Firm initiated recall is ongoing.
REASON : This is an expansion of Recall # Z-866-2010, adding an
additional two lots to the recall of EXXCEL soft Stand Wall EPTFE
Vascular Grafts due to a labeling mix up.
PRODUCT :
43 Coated VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic
Absorbable Suture, Undyed. Intended use: Soft Tissue approximation.
Recall # Z-1608-2010
MANUFACTURER : Recalling Firm: Ethicon, Inc., Somerville, NJ, by letters
dated April 20, 2010. Manufacturer: Ethicon GmbH, Norderstedt, Germany.
Firm initiated recall is ongoing.
REASON : Channels in the packaging seal that can lead to suture
degradation and loss of packaging integrity.
PRODUCT :
Odyssey Intended use: Radiation treatment planning system. Recall #
Z-1609-2010
MANUFACTURER : PerMedics, Inc., San Bernardino, CA, by letter dated
March 23, 2010. Firm initiated recall is ongoing.
REASON : Anomaly 1, Invalid Characters in Patient ID Error: Currently,
Odyssey considers a valid ID to be comprised of numbers and/or letters.
If a patient ID in a study contains a character other than a letter or
number (including spaces). Odyssey removes the invalid character when
moving it to a patient folder. Due to this, it is possible that two
different patient studies could be listed within Odyssey for one
patient. Anomaly 2, Odyssey Machine Library Error: The Odyssey Machine
Library contains configuration formation for each treatment machine.
mode, etc. Currently, if the 44 Machine Library contains treatment modes
with two different collimator types (for example, jaws and cones), then
it is possible for the software to use the incorrect collimator type
when calculating dose. It was tested and confirmed that based on our
records of the current customers' libraries, this anomaly will not
occur. This anomaly can occur ONLY if the user modified the commissioned
Machine Library without PerMedics' knowledge such that the treatment
mode that uses circular cones is listed as the first mode in the Machine
Library before the photon mode using jaws AND the mode using jaws is
selected during planning. In this case, the software would automatically
use the incorrect collimator type (cone) when calculating dose. Anomaly
3, Odyssey MLC Block Error: Odyssey allows the user to add an Odyssey
MLC block (a virtual block) to move the MLC leaves automatically to
cover a selected tissue region. When a virtual block is used, a block
tray would not be expected in setup; however, Odyssey currently
considers a block tray transmission factor when calculating dose with an
Odyssey MLC block. The dose can be oft' by as much as a tray factor,
which is typically 2-5%, depending on beam energy. The use of the tray
factor used is clearly indicated on the DICOM RT Plan and Odyssey report
exported.
PRODUCT :
Newport e360 Ventilator The e360 Ventilator System is intended to
provide continuous (endotracheal or tracheostomy [ET] tube) or
non-continuous (mask) ventilatory support and monitoring for infant,
pediatric, and adult patients requiring tidal volumes equal to or
greater than 20 milliliters (mL). The device is for use by prescription
only. The intended environments include hospital, hospital-type, and
intra-hospital transport environments. Hospital use typically includes
general care floors, operating rooms, special procedure areas, emergency
rooms, and intensive and critical care areas within the hospital.
Hospital-type use includes facilities such as or similar to surgicenters,
sub-acute centers, and special nursing facilities outside of the
hospital. Intra-hospital transport includes patient transport within the
hospital or hospital-type facility. Recall # Z-1617-2010
MANUFACTURER : Newport Medical Instruments Inc., Costa Mesa, CA, by
letter dated April 14, 2010. Firm initiated recall is ongoing.
REASON : The recall was initiated due to a recent increase in complaints
related to the early failure of a low pressure transducer which is on
Printed Circuit Board (PCB) 2104A in the Newport e360 ventilator.
Ventilators manufactured between September and December 2009 are
affected by this field correction. All affected ventilators require the
replacement of the PCB2104A board to avoid early failure of this
pressure transducer. The failure of the pressure transducer results in
pressure or volume alarms where P1 cannot be calibrated correctly or in
a Device Alert alarm associated with a P1 failure. In most cases, the
failure is detected at power on but failures can occur during
ventilation.
PRODUCT :
HeartStart MRx Defibrillator Monitor, Model M3535A HeartStart MRx
Defibrillator Monitor, Model M3536A The HeartStart MRx is for use for
the termination of ventricular tachycardia and ventricular fibrillation.
The device is for use by qualified medical personnel trained in the
operation of the device and qualified by training in basic life support,
advanced cardiac support, or defibrillation. It must be used by or on
the order of a physician. Recall # Z-1618-2010
MANUFACTURER : Philips Healthcare Inc., Andover, MA, by letter dated
April 7, 2009. Firm initiated recall is ongoing.
REASON : ECG signal processing chip may fail causing failure to deliver
therapy in AED mode or the failure to indicate poor electrical contact
(very high impedance) with the patient in Manual Defib mode.
PRODUCT :
Inserter Wand Holder, Non-Sterile. Intended use: The Inserter Wand
Holder serves two key functions. It firmly secures the Inserter Wand to
prevent recoil during the NeuroPort Array 50 insertion process, and it
facilitates precision alignment of the Inserter Wand with respect to the
back of the NeuroPort Array just prior to pneumatic impulse insertion.
Recall # Z-1619-2010
MANUFACTURER : I2s Micro Implantable Systems LLC, Salt Lake City, UT, by
letter dated March 26, 2010. Firm initiated recall is ongoing.
REASON : Component of cranial array may not allow sufficient tightening
to maintain inserter position.
PRODUCT :
1) Bausch & Lomb Millennium Microsurgical System Vit Enhancer (MVE). The
MVE provides a pneumatic pulse train capable of driving a Vitreous
Cutter at cutting rates up to 2500 cuts per minute. It is intended to be
used for removal of vitreous or other intraocular tissue. Recall #
Z-1662-2010; 2) Bausch & Lomb Millennium Microsurgical System Bausch &
Lomb Millennium Microsurgical System is designed for use in both
anterior and posterior segment surgeries. It provides capabilities for
phacoemulsification, irrigation/aspiration, bipolar and photo
coagulation, vitrectomy, viscous fluid injection/removal, and air/fluid
exchange operations. Recall # Z-1663-2010; 3) Bausch & Lomb Stellaris
Vision Enhancement System Bausch & Lomb Millennium Microsurgical System
is designed for use in both anterior and posterior segment surgeries. It
provides capabilities for phacoemulsification, irrigation/aspiration,
bipolar and photo coagulation, vitrectomy, viscous fluid
injection/removal, and air/fluid exchange operations. Recall #
Z-1664-2010
MANUFACTURER : Recalling Firm: Bausch & Lomb Inc., Rochester, NY, by
letter dated October 19, 2009. Manufacturer: Bausch & Lomb Inc., Saint
Louis, MO. Firm initiated recall is ongoing.
REASON : The AC power cords used on these products are subject to an FDA
Alert -- Safety Investigation of Certain Medical Device Power Cords:
Initial Communication.
PRODUCT :
51 Responder 2000 Defibrillator/Monitor Models: 2025653, 2026109, and
2026114. Intended use: The Responder 2000 is indicated for the
termination of certain fatal arrhythmias, such as ventricular
fibrillation and symptomatic ventricular tachycardia. Delivery of energy
in the synchronized mode is a method for treating atrial fibrillation,
atrial flutter, paroxysmal supraventricular tachycardia, and in
relatively stable patients, ventricular tachycardia. The semi-automatic
advisory mode is for use in cardiac arrest in patients of at least 8
years of age. The patient must be unconscious, pulseless, and not
breathing spontaneously before using the defibrillator to analyze the
patient's ECG rhythm. The 3-lead and 5-lead ECG monitoring allows for
identification of interpretation of cardiac rhythms or dysrhythmias and
calculation of heart rate. The Responder 2000 noninvasive pacing as a
therapy is indicated for patients with symptomatic bradycardia or
asystole. The pulse oximetry is intended for the continuous external
monitoring of arterial oxygen saturation and pulse rate and is indicated
for use in any patient who is at risk of developing hypoxemia. MODELS:
2025653, 2026109, AND 2026114. The model numbers identify different AED
configurations: MODEL 2025653 is the basic model; MODEL 2026109 is the
basic model with pacing; and MODEL 2026114 is the basic model with
pacing and SpO2 (oxygen saturation measured by pulse oximetry).
OPERATOR'S MANUAL PART NUMBERS: (the 3 digit number at the end
identifies the language in which the manual is written. Regardless of
language the manuals are identical in content.) 2026116-001,
2026116-004, 2026116-005, 2026116-008, 2026116-010, 2026116-011,
2026116-012, 2026116-013, 2026116-014, 2026116-015, 2026116-016,
2026116-019, 2026116-022, 2026116-024, 2026116-025, 2026116-026,
2026116-033, AND 2026116-044. Recall # Z-1683-2010
MANUFACTURER : Cardiac Science Corp., Bothell, WA, by letter dated
October 15, 2009. Firm initiated recall is ongoing.
REASON : The Operators Manual may not have adequate information to
clearly explain some device behaviors. Pressing and holding down the
Charge or Shock button on the Responder 2000 for more than 5 seconds
causes a "Button Stuck" error. With the "Button Stuck" error, the device
will automatically exit Manual mode and enter Monitor mode. The user
cannot apply therapy while the device is in Monitor mode.
PRODUCT
The Alternans Sensor Kit Assembly is a sealed kit that contains the
components necessary for conducting a Microvolt Twave Alternans test.
Recall # Z-1776-2010
MANUFACTURER : 56 Cambridge Heart, Inc., Tewksbury, MA, by letter dated
April 23, 2010. Firm initiated recall is ongoing.
REASON : Some kits contained a component with expiration date prior to
the date of expiry on the outside of the kit. The user receives feedback
of potential unreliable results at several stages during the test
process, so any risk of unreliable results is very low.
PRODUCT :
DATEX-Ohmeda Tusat Pulse Oximeter and Accessories, Model 3500. Recall #
Z-1814-201134
MANUFACTURER :
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated April
22, 2010.
Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Firm
initiated recall is ongoing.
REASON : GE Healthcare has recently become aware that the TruSat Pulse
Oximeter with external power supply does not comply with current safety
standards. It is possible that the external power supply could leak
electrical current. This current could cause third degree burns or an
abnormal heart rhythm that, if untreated, could lead to death.
CLASS III
PRODUCT :
Pelton & Crane Spirit 3000 Dental Chair. The intended use of this device
is for properly positioning patients to perform dental procedures.
Catalog number: 3003, Model number: SP30. Recall # Z-1311-2010
MANUFACTURER : Pelton & Crane Co., Charlotte, NC, by letter dated
February 9, 2010. Firm initiated recall is ongoing.
REASON : The Dental Chair lacks a valid Device History Record.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
June 16, 2010
CLASS II
PRODUCT :
1) Stryker Reflex Hybrid Screw Extractor; Not Sterile. The threaded tip
of the Reflex Hybrid Screw Extractor has been found to fracture the head
of the screw, causing problems in removing the screw and possible damage
to the screw and/or plate while attempting to remove the screw. Ref #
48511905. Recall # Z-0762-2010
2) Stryker Reflex Hybrid Screw Extractor Inner Shaft; Not Sterile. The
threaded tip of the Reflex Hybrid Screw Extractor has been found to
fracture the head of the screw, causing problems in removing the screw
and possible damage to the screw and/or plate while attempting to remove
the screw. Ref # 48511905B. Recall # Z-0763-2010
MANUFACTURER:Recalling Firm: Stryker Spine, Allendale, NJ, by letter on
October 12, 2009 and October 26, 2009.
Manufacturer: Stryker Spine SAS, Cestas, France. Firm initiated recall
is ongoing.
REASON:The threaded tip of the Reflex Hybrid Screw Extractor has been
found to fracture the head of the screw, causing problems in removing
the screw and possible damage to the screw and/or plate while attempting
to remove the screw.
PRODUCT :
1) Abbott i-STAT ACT Celite Cartridges. In vitro diagnostic test used to
monitor moderate and high-level heparin therapy through analysis of
arterial and venous whole blood samples. Catalog number: 07G01-1. Recall
# Z-0813-2010;
2) Abbott i-STAT ACT Kaolin Cartridges. In vitro diagnostic test which
uses fresh whole blood to monitor high-dose heparin anticoagulation
frequently associated with cardiovascular surgery. Catalog number:
07G81-01. Recall # Z-0814-2010
MANUFACTURER: Abbott Point of Care Inc., Princeton, NJ, by letter
beginning August 18, 2009. Firm initiated recall is ongoing.
REASON: Labeling discrepancy: The manual instruction state that the line
should be flushed with 5 mL of saline and the first 5 mL of blood or six
dead space volumes should be discarded. The Cartridge Test Information
sheets that it should be 2 mL of blood - which is incorrect.
PRODUCT :
1) Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit..
Latex slide agglutination test for the differentiation of staphylococcus
aureus by detection of clumping factor, Protein A and certain
polysaccarides found in methicillin-resistant S. aureus (MRSA) from
those staphylococci that do not possess these properties. Recall #
Z-0817-2010
2) Staphytect Plus, packaged in 100- and 500-test boxes, Catalog
#DR0850M (100 tests) and #DR0850B (500 tests). Latex slide agglutination
test for the differentiation of staphylococcus aureus by detection of
clumping factor, Protein A and certain polysaccarides found in
methicillin-resistant S. aureus (MRSA) from those staphylococci that do
not possess these properties. Recall # Z-0818-2010
MANUFACTURER: Recalling Firm: Remel, Inc., Lenexa, KS, by letters dated
July 20, 2009 and October 19, 2009. Manufacturer: Oxoid, Ltd.,
Basingstoke, United Kingdom. Firm initiated recall is complete.
REASON: The products may give false positive results with some
non-Staphylococcus aureus strains.
PRODUCT :
1) Mistique Infusion Catheter, MIC5-90-5-035, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0872-2010;
2) Mistique Infusion Catheter, MIC5-90-20-038, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0873-2010;
3) Mistique Infusion Catheter, MIC5-90-20-035, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0874-2010;
4) Mistique Infusion Catheter, MIC5-90-10-038, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0875-2010;
5) Mistique Infusion Catheter, MIC5-90-10-035, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0876-2010;
6) Mistique Infusion Catheter, MIC5-45-5-035, Sterile EO. Intended to
administer infusions of 0various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0877-2010;
7) Mistique Infusion Catheter, MIC5-45-5-038, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0878-2010;
8) Mistique Infusion Catheter, MIC5-45-20-038, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0879-2010;
9) Mistique Infusion Catheter, MIC5-45-20-035, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0880-2010;
10) Mistique Infusion Catheter, MIC5-45-10-038, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0881-2010;
11) Mistique Infusion Catheter, MIC5-45-10-035, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0882-2010;
12) Mistique Infusion Catheter, MIC5-135-5-038, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0883-2010;
13) Mistique Infusion Catheter, MIC5-135-5-035, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0884-2010;
14) Mistique Infusion Catheter, MIC5-135-20-038, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0885-2010;
15) Mistique Infusion Catheter, MIC5-135-20-035, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0886-2010;
16) Mistique Infusion Catheter, MIC5-135-10-038, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0887-2010;
17) Mistique Infusion Catheter, MIC5-135-10-035, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0888-2010;
18) Mistique Infusion Catheter, K12-MIC13510, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0889-2010;
19) Mistique Infusion Catheter, K12-MIC13505, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0890-2010;
20) Mistique Infusion Catheter, K12-MIC09010, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0891-2010
21) Mistique Infusion Catheter, K12-MIC09005, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0892-2010;
22) Mistique Infusion Catheter, K12-MIC04510, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0893-2010;
23) Mistique Infusion Catheter, K12-MIC04505, Sterile EO. Intended to
administer infusions of various therapeutic solutions into the
peripheral vasculature of a patient. Recall # Z-0894-2010
MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by
telephone and letter on January 6, 2010. Firm initiated recall is
ongoing.
REASON: Infusion catheters may become brittle and break during use.
PRODUCT :
1) 10 degree Tibial Augment Wedge, a component of Ortho Balanced Knee
Modular Tibial System. The device is a component of Balanced Knee
Modular Tibial System and is indicated for patients suffering from
severe knee pain and disability. The indications for use are: 1) loss of
joint configuration and joint function, 2) Osteoarthritis of the knee
joint, 3) Rheumatoid arthritis of the knee joint, 4) Post-traumatic
arthritis of the knee joint, 5) Moderate valgus, varus, or flexion
deformities and 6) Revision procedures where other treatments or devices
have failed. Recall # Z-1228-2010;
2) 5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular
Tibial System. The device is a component of Balanced Knee Modular Tibial
System and is indicated for patients suffering from severe knee pain and
disability. The indications for use are: 1) loss of joint configuration
and joint function, 2) Osteoarthritis of the knee joint, 3) Rheumatoid
arthritis of the knee joint, 4) Post-traumatic arthritis of the knee
joint, 5) Moderate valgus, varus, or flexion deformities and 6) Revision
procedures where other treatments or devices have failed. Recall #
Z-1229-2010
MANUFACTURER: Ortho Development Corp., Draper, UT, by e-mail on March
19, 2009. Firm initiated recall is completed.
REASON: A component of knee prosthesis was assembled incorrectly.
PRODUCT :
1) Envoy 500 Serum Control Kit. The device is used for monitoring the
performance of clinical chemistry methods within the clinical range.
Recall # Z-1233-2010;
2) ATAC Serum Control Kit. The device is used for monitoring the
performance of clinical chemistry methods within the clinical range.
Recall # Z-1234-2010
MANUFACTURER: Vital Diagnostics, Inc., Lincoln, RI, by copies of
Technical Bulletin 8100 and 5024 dated September 30, 2009. Firm
initiated recall is ongoing.
REASON: Vital Diagnostics observed a bias in the Quality Control
Consensus Program between published values for ALP on the ATAC 8000 and
reported customer means. The ranges were adjusted to reflect the
analyzer population.
PRODUCT :
1) PROMOS Inclination set, Size 20mm, REF 42 180, S&N75006722, Qty: (1),
Sterile R. The device is used as a semi-constrained, metal/polymer
cemented shoulder prosthesis. Recall # Z-1239-2010;
2) PROMOS Inclination set, Size 22mm, REF 42 184, S&N75006723, Qty: (1),
Sterile R. The device is used as a semi-constrained, metal polymer
cemented shoulder prosthesis. Recall # Z-1240-2010;
3) PROMOS Inclination set, Size 24mm, REF 42 184, S&N75006724, Qty: (1),
Sterile R. The device is used as a semi-constrained, metal polymer
cemented shoulder prosthesis. Recall # Z-1241-2010;
4) PROMOS Inclination set, Size 26mm, REF 42 186, S&N75006725, Qty: (1),
Sterile R. The device is used as a semi-constrained, metal/polymer
cemented shoulder prosthesis. Recall # Z-1242-2010;
MANUFACTURER: Recalling Firm: Smith & Nephew Inc., Memphis, TN, by
letter, email and/or telephone on January 23, 2009. Manufacturer: Smith
& Nephew Orthopaedics AG, Aarau, Switzerland. Firm initiated recall is
ongoing.
REASON: Firm received complaints of Inclination Set Screws fracturing.
PRODUCT :
ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and
5F48-23; Part Number 7-204717-01 and 7-204717-02 when used with PM
Algorithm LLS Brd, part number 7-94255-01 and PM LLS kit, U10 Chip and
Ejectors, part number 7-200788-01. The Abbott ARCHITECT System is
designed to perform automated: Chemistry tests utilizing photometry and
potentiometric technology, and immunoassay tests utilizing CMIA
detection technology. Recall # Z-1316-2010
MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on
September 11, 2009. Firm initiated recall is ongoing.
REASON: ARCHITECT System Software v5.00 and v5.10 are incompatible with
ARCHITECT LLS Board. Software patch re-establishes correct parameters.
PRODUCT :
HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J)
used with Philips 14.8-Volt Lithium Ion Battery (ModeI M3538A). The
HeartStart MRx is for use for the termination of ventricular tachycardia
and ventricular fibrillation. The device is for use by qualified medical
personnel trained in the operation of the device and qualified by
training in basic life support, advanced cardiac support, or
defibrillation. It must be used by or on the order of a physician.
Recall # Z-1317-2010
MANUFACTURER: Philips Healthcare Inc., Andover, MA, by letter on March
4, 2010. Firm initiated recall is ongoing.
REASON: Batteries older than 2 years have a higher potential for
intermittent electrical contact, may contribute to an interruption in
monitoring or therapy if the monitor/defibrillator is operating on
battery.
PRODUCT :
1) V-Probe, Endocare Cryo V Probe model # Cryo 206V. The product is used
in a minimally invasive, percutaneous approach to treating prostate
cancer in low, moderate and high risk patients. Prostate Cryoablation
uses extremely cold temperatures to destroy cancerous tissue. Recall #
Z-1400-2010;
2) V-Probe, Endocare Cryo V Probe, single unit model # CVA2400. The
product is used in a minimally invasive, percutaneous approach to
treating prostate cancer in low, moderate and high risk patients.
Prostate Cryoablation uses extremely cold temperatures to destroy
cancerous tissue. Recall # Z-1401-2010
MANUFACTURER: Endocare, a Wholly Owned Subsidiary of HealthTronics,
Inc., Irvine, CA, by letter on December 5, 2008. Firm initiated recall
is complete.
REASON: Endocare received a report of a patient death that occurred
during a prostate cryoablation procedure. An autopsy attributed the
cause of death to an air embolism. The safety notice for the cryoprobes
was issued to refocus attention on the Indications and Safety Review
included with the Physician Training Materials and to reinforce
additional safety information.
PRODUCT :
1) CELL-DYN 1700, list numbers 03H5301 and 03H53-03. Recall #
Z-1628-2010;
2) CELL-DYN 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03.
Recall # Z-1629-2010;
3) CELL-DYN 1800, list numbers 07H77-01, 07H77-03. Recall # Z-1630-2010
MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letters beginning
June 8, 2009. Firm initiated recall is ongoing.
REASON: Use of Syringe LN 04H36-01 with the Die-cast syringe drive may
result in leakage, leading to delay in reporting patient results.
PRODUCT :
Voiceware clip software update to certain Horizon Medical Imaging
Systems. Intended to receive, transmit, store, retrieve, display, print
and process digital medical images, digital medical video and associated
medical information from various medical imaging systems. Recall #
Z-1735-2010
MANUFACTURER: Mckesson Medical Imaging, Richmond British Columbia,
Canada, by letter dated May 7, 2010. Firm initiated recall is ongoing.
REASON: Voice Clip issue: When the user is recording voice clips in
Horizon Rad Station, there is a potential for voice clips to be saved to
the incorrect study of the same patient.
CLASS II
PRODUCT :
Rabbit Kidney Culture, brand name: 'FreshCells'. The product is labeled
as 'Rabbit Kidney' also known as 'Rbk', 2-square cm area of a cell
monolayer covered with 2-mL culture medium. The product is packed in
glass culture tubes 16x125mm, with screw caps. The product is
distributed in EPS shipping racks which can hold up to 50 tubes each.
Used routinely for in vitro diagnostic testing for virus and/or
Chlamydia isolation and to aid in the diagnosis of diseases associated
with infectious agents. Catalog Number: 48-0600. Recall # Z-0822-2010
MANUFACTURER: Diagnostic Hybrids Inc., Athens, OH, by letter dated
January 23, 2009 and verbal communication beginning January 21, 2009.
Firm initiated recall is ongoing.
REASON: During QC post release monitoring, the firm determined that the
monolayer culture of rabbit kidney cells previously distributed by the
firm, appeared to contain another type of cells (monkey kidney cells).
PRODUCT :
Aplicare Advantage Dressing Change System, Central Line Dressing Change,
Sterile Part number: A3402. The product is used for Central Line
Dressing Change. Recall # Z-1310-10
MANUFACTURER: Recalling Firm: Aplicare, Inc., Meriden, CT, by telephone
and letter on March 3, 2010.Manufacturer: Aplicare, Inc., Prichard, WV.
Firm initiated recall is complete.
REASON: Incorrect expiration date on outer kit label-extended.
PRODUCT :
1) KODAK T-MAT L/RA Film, Catalog/REF # 181 4631, 35x43 cm 5-100 Sheet
Boxes Folhas/Hojas, Device Listing # E420904 Intended use: Imaging film.
Recall # Z-1314-2010;
2) KODAK T-MAT G/RA Film, Catalog/REF # 151 0023, 24x30 cm, 5-100 Sheet
Boxes FOLHAS/Hojas, Device Listing # E420904 Intended use: Imaging film.
Recall # Z-1315-2010
MANUFACTURER: Recalling Firm: Carestream Health, Inc., Rochester, NY, by
letters dated March 12, 2010 and by email beginning on March 12,
2010.Manufacturer: Carestream Health, Inc., White City, OR. Firm
initiated recall is ongoing.
REASON: Product mix-up. The firm received a customer complaint
indicating that the customer had opened a box of film and although it
was supposed to be T-MAT L/RA, it was performing like T-MAT G/RA.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
June 9, 2010
CLASS I
PRODUCT:
1) Bard Mesh Monofilament Knitted Polypropylene; Contents: size 2" x 4",
3 units per box. Intended as reinforcement of soft tissue where weakness
exists. Item Code: 0112650. Recall # Z-1647-2010;
2) Bard Mesh Monofilament Knitted Polypropylene; size 10 x 14", 3 units
per box; Intended as reinforcement of soft tissue where weakness exists.
Item Code: 0112660. Recall # Z-1648-2010;
3) Bard Mesh Monofilament Knitted Polypropylene; size 3" x 6", 3 units
per box. Intended as reinforcement of soft tissue where weakness exists.
Item Code: 0112680. Recall # Z-1649-2010;
4) Bard Mesh Monofilament Knitted Polypropylene Flat Mesh; size 6" x 6",
3 per box; Intended as reinforcement of soft tissue where weakness
exists. Item Code: 0112720. Recall # Z-1650-2010
MANUFACTURER: Ram Medical Inc., Wayne, NJ, by telephone beginning March
4, 2010 and letters beginning March 8, 2010. Firm initiated recall is
ongoing.
REASON: Counterfeit product mixed with authentic product. The problem
was recognized by the mismatching of expiration dates and the subtle
differences in packaging.
CLASS II
PRODUCT:
1) Bausch & Lomb Millennium Basic Venturi Phaco Pack, Models DP4305 and
DP4305E, 12 packs/box, RX, Sterile. The plastic needle wrench contained
in the package is used to tighten or untighten phacoemulsification
needles on phaco handpieces of the Millenium and Stellaris machines. The
Millenium and Stellaris are used by ophthalmic surgeons to emulsify and
aspirate cataract material during cataract surgery, to cut and aspirate
vitreous material during anterior and posterior segment surgery, and to
drive a variety of handpieces during posterior segment surgery. Recall #
Z-1708-2010;
2) Bausch & Lomb Millennium Premium Venturi Phaco Pack, Model DP4310 and
DP4310E, 6 packs/box, RX, Sterile. The plastic needle wrench contained
in the package is used to tighten or untighten phacoemulsification
needles on phaco handpieces of the Millenium and Stellaris machines. The
Millenium and Stellaris are used by ophthalmic surgeons to emulsify and
aspirate cataract material during cataract surgery, to cut and aspirate
vitreous material during anterior and posterior segment surgery, and to
drive a variety of handpieces during posterior segment surgery. Recall #
Z-1709-2010;
3) Bausch & Lomb Millennium Advanced Flow System Phaco Pack, Model
CX5310, 6 packs/box, RX, Sterile. The plastic needle wrench contained in
the package is used to tighten or untighten phacoemulsification needles
on phaco handpieces of the Millenium and Stellaris machines. The
Millenium and Stellaris are used by ophthalmic surgeons to emulsify and
aspirate cataract material during cataract surgery, to cut and aspirate
vitreous material during anterior and posterior segment surgery, and to
drive a variety of handpieces during posterior segment surgery. Recall #
Z-1710-2010;
4) Bausch & Lomb Millennium Micro Incision Premium Venturi Pack, Model
CX4320, 6 packs/box, RX, Sterile. The plastic needle wrench contained in
the package is used to tighten or untighten phacoemulsification needles
on phaco handpieces of the Millenium and Stellaris machines. The
Millenium and Stellaris are used by ophthalmic surgeons to emulsify and
aspirate cataract material during cataract surgery, to cut and aspirate
vitreous material during anterior and posterior segment surgery, and to
drive a variety of handpieces during posterior segment surgery. Recall #
Z-1711-2010;
5) Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Model BL5110, 6
packs/box, RX, Sterile. The plastic needle wrench contained in the
package is used to tighten or untighten phacoemulsification needles on
phaco handpieces of the Millenium and Stellaris machines. The Millenium
and Stellaris are used by ophthalmic surgeons to emulsify and aspirate
cataract material during cataract surgery, to cut and aspirate vitreous
material during anterior and posterior segment surgery, and to drive a
variety of handpieces during posterior segment surgery. Recall #
Z-1712-2010;
6) Bausch & Lomb Stellaris Vacuum Phaco Pack, Model BL5111, 6 packs/box,
RX, Sterile. The plastic needle wrench contained in the package is used
to tighten or untighten phacoemulsification needles on phaco handpieces
of the Millenium and Stellaris machines. The Millenium and Stellaris are
used by ophthalmic surgeons to emulsify and aspirate cataract material
during cataract surgery, to cut and aspirate vitreous material during
anterior and posterior segment surgery, and to drive a variety of
handpieces during posterior segment surgery. Recall # Z-1713-2010;
7) Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Model
BL5112, 6 packs/box, RX, Sterile. The plastic needle wrench contained in
the package is used to tighten or untighten phacoemulsification needles
on phaco handpieces of the Millenium and Stellaris machines. The
Millenium and Stellaris are used by ophthalmic surgeons to emulsify and
aspirate cataract material during cataract surgery, to cut and aspirate
vitreous material during anterior and posterior segment surgery, and to
drive a variety of handpieces during posterior segment surgery. Recall #
Z-1714-2010;
8) Bausch & Lomb Stellaris Premium AFS Phaco Pack, Model BL5120, 6
packs/box, RX, Sterile. The plastic needle wrench contained in the
package is used to tighten or untighten phacoemulsification needles on
phaco handpieces of the Millenium and Stellaris machines. The Millenium
and Stellaris are used by ophthalmic surgeons to emulsify and aspirate
cataract material during cataract surgery, to cut and aspirate vitreous
material during anterior and posterior segment surgery, and to drive a
variety of handpieces during posterior segment surgery. Recall #
Z-1715-2010;
9) Bausch & Lomb Stellaris Basic AFS Phaco Pack, Model BL5121, 6
packs/box, RX, Sterile. The plastic needle wrench contained in the
package is used to tighten or untighten phacoemulsification needles on
phaco handpieces of the Millenium and Stellaris machines. The Millenium
and Stellaris are used by ophthalmic surgeons to emulsify and aspirate
cataract material during cataract surgery, to cut and aspirate vitreous
material during anterior and posterior segment surgery, and to drive a
variety of handpieces during posterior segment surgery. Recall #
Z-1716-2010;
10) Bausch & Lomb Stellaris 1.8mm StableChamber Phaco Pack with MICS
Needle, Model BL5113, 6 packs/box, RX, Sterile. The plastic needle
wrench contained in the package is used to tighten or untighten
phacoemulsification needles on phaco handpieces of the Millenium and
Stellaris machines. The Millenium and Stellaris are used by ophthalmic
surgeons to emulsify and aspirate cataract material during cataract
surgery, to cut and aspirate vitreous material during anterior and
posterior segment surgery, and to drive a variety of handpieces during
posterior segment surgery. Recall # Z-1717-2010;
11) Bausch & Lomb Stellaris 1.8mm StableChamber Phaco Pack with MICS
Angled Needle, Model BL5113A, 6 packs/box, RX, Sterile. The plastic
needle wrench contained in the package is used to tighten or untighten
phacoemulsification needles on phaco handpieces of the Millenium and
Stellaris machines. The Millenium and Stellaris are used by ophthalmic
surgeons to emulsify and aspirate cataract material during cataract
surgery, to cut and aspirate vitreous material during anterior and
posterior segment surgery, and to drive a variety of handpieces during
posterior segment surgery. Recall # Z-1718-2010;
12) Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS
Needle, Model BL5114, 6 packs/box, RX, Sterile. The plastic needle
wrench contained in the package is used to tighten or untighten
phacoemulsification needles on phaco handpieces of the Millenium and
Stellaris machines. The Millenium and Stellaris are used by ophthalmic
surgeons to emulsify and aspirate cataract material during cataract
surgery, to cut and aspirate vitreous material during anterior and
posterior segment surgery, and to drive a variety of handpieces during
posterior segment surgery. Recall # Z-1719-2010;
13) Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS
Angled Needle, Model BL5114A, 6 packs/box, RX, Sterile. The plastic
needle wrench contained in the package is used to tighten or untighten
phacoemulsification needles on phaco handpieces of the Millenium and
Stellaris machines. The Millenium and Stellaris are used by ophthalmic
surgeons to emulsify and aspirate cataract material during cataract
surgery, to cut and aspirate vitreous material during anterior and
posterior segment surgery, and to drive a variety of handpieces during
posterior segment surgery. Recall # Z-1720-2010;
14) Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with
MICS Needle, Model BL5123, 6 packs/box, RX, Sterile. The plastic needle
wrench contained in the package is used to tighten or untighten
phacoemulsification needles on phaco handpieces of the Millenium and
Stellaris machines. The Millenium and Stellaris are used by ophthalmic
surgeons to emulsify and aspirate cataract material during cataract
surgery, to cut and aspirate vitreous material during anterior and
posterior segment surgery, and to drive a variety of handpieces during
posterior segment surgery. Recall # Z-1721-2010;
15) Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with
MICS Angled Needle, Model BL5123A, 6 packs/box, RX, Sterile. The plastic
needle wrench contained in the package is used to tighten or untighten
phacoemulsification needles on phaco handpieces of the Millenium and
Stellaris machines. The Millenium and Stellaris are used by ophthalmic
surgeons to emulsify and aspirate cataract material during cataract
surgery, to cut and aspirate vitreous material during anterior and
posterior segment surgery, and to drive a variety of handpieces during
posterior segment surgery. Recall # Z-1722-2010;
16) Bausch & Lomb 19G Standard 30 Phaco Needle, Model DP8130S, 6
pouches/box. The plastic needle wrench contained in the package is used
to tighten or untighten phacoemulsification needles on phaco handpieces
of the Millenium and Stellaris machines. The Millenium and Stellaris are
used by ophthalmic surgeons to emulsify and aspirate cataract material
during cataract surgery, to cut and aspirate vitreous material during
anterior and posterior segment surgery, and to drive a variety of
handpieces during posterior segment surgery. Recall # Z-1723-2010;
17) Bausch & Lomb 19G Standard 45 Phaco Needle, Model DP8145S, 6 pouches
per box. The plastic needle wrench contained in the package is used to
tighten or untighten phacoemulsification needles on phaco handpieces of
the Millenium and Stellaris machines. The Millenium and Stellaris are
used by ophthalmic surgeons to emulsify and aspirate cataract material
during cataract surgery, to cut and aspirate vitreous material during
anterior and posterior segment surgery, and to drive a variety of
handpieces during posterior segment surgery. Recall # Z-1724-2010;
18) Bausch & Lomb MicroFlow 30 Phaco Needle, Model DP8230S, 6
pouches/box. The plastic needle wrench contained in the package is used
to tighten or untighten phacoemulsification needles on phaco handpieces
of the Millenium and Stellaris machines. The Millenium and Stellaris are
used by ophthalmic surgeons to emulsify and aspirate cataract material
during cataract surgery, to cut and aspirate vitreous material during
anterior and posterior segment surgery, and to drive a variety of
handpieces during posterior segment surgery. Recall # Z-1725-2010;
19) Bausch & Lomb MicroFlow 45 Phaco Needle, Model DP8245S, 6
pouches/box. The plastic needle wrench contained in the package is used
to tighten or untighten phacoemulsification needles on phaco handpieces
of the Millenium and Stellaris machines. The Millenium and Stellaris are
used by ophthalmic surgeons to emulsify and aspirate cataract material
during cataract surgery, to cut and aspirate vitreous material during
anterior and posterior segment surgery, and to drive a variety of
handpieces during posterior segment surgery. Recall # Z-1726-2010;
20) Bausch & Lomb MicroFlow Plus 30 Phaco Needle, Model DP8330S, 6
pouches/box. The plastic needle wrench contained in the package is used
to tighten or untighten phacoemulsification needles on phaco handpieces
of the Millenium and Stellaris machines. The Millenium and Stellaris are
used by ophthalmic surgeons to emulsify and aspirate cataract material
during cataract surgery, to cut and aspirate vitreous material during
anterior and posterior segment surgery, and to drive a variety of
handpieces during posterior segment surgery. Recall # Z-1727-2010;
21) Bausch & Lomb Thin Tip 30 Phaco Needle, Model DP8430S, 6
pouches/box. The plastic needle wrench contained in the package is used
to tighten or untighten phacoemulsification needles on phaco handpieces
of the Millenium and Stellaris machines. The Millenium and Stellaris are
used by ophthalmic surgeons to emulsify and aspirate cataract material
during cataract surgery, to cut and aspirate vitreous material during
anterior and posterior segment surgery, and to drive a variety of
handpieces during posterior segment surgery. Recall # Z-1728-2010;
22) Bausch & Lomb Thin Tip 30 angled Phaco Needle, Model DP8430AS, 6
pouches/box. The plastic needle wrench contained in the package is used
to tighten or untighten phacoemulsification needles on phaco handpieces
of the Millenium and Stellaris machines. The Millenium and Stellaris are
used by ophthalmic surgeons to emulsify and aspirate cataract material
during cataract surgery, to cut and aspirate vitreous material during
anterior and posterior segment surgery, and to drive a variety of
handpieces during posterior segment surgery. Recall # Z-1729-2010;
23) Bausch & Lomb MicroFlow 2.2 30 Phaco Needle, Model DP8730S, 6
pouches/box. The plastic needle wrench contained in the package is used
to tighten or untighten phacoemulsification needles on phaco handpieces
of the Millenium and Stellaris machines. The Millenium and Stellaris are
used by ophthalmic surgeons to emulsify and aspirate cataract material
during cataract surgery, to cut and aspirate vitreous material during
anterior and posterior segment surgery, and to drive a variety of
handpieces during posterior segment surgery. Recall # Z-1730-2010
MANUFACTURER: Recalling Firm: Bausch & Lomb Inc., Rochester, NY, by
letter dated January 7, 2010.Manufacturer: Bausch & Lomb Inc., Saint
Louis, MO. Firm initiated recall is ongoing.
REASON: Users may incorrectly assemble the plastic needle wrench to the
phacoemulsification needle resulting in the generation of plastic
particulate.
PRODUCT :
GE Healthcare, Seno Advantage 2.2 workstations with software version
22_01 and 22_02 Seno Advantage is a medical image review station that
allows easy selection, processing, filming and media interchange of
multi-modality images from a variety of diagnosis imaging systems. When
interpreted by a trained physician, mammographic images displayed on the
high-resolution monitors may be used as an element for diagnosis.
Furthermore filmed images from all modalities may also be used as an
element for diagnosis. Recall # Z-1747-2010
MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by
letter dated February 8, 2010.Manufacturer: GE Medical Systems, SCS, Buc
Cedex, France. Firm initiated recall is ongoing.
REASON: GE Healthcare has recently become aware of inaccurate Scale
factor annotation provided by SenoAdvantage 2.2 workstations that may
impact patient safety. When using the Print Image or Print Screen
feature on SenoAdvantage 2.2, the Scale factor annotation printed on
hard copy images is inaccurate. Secondary Capture (SCPT) images
displayed on the screen and Secondary Capture hard copy images may also
contain the inaccurate Scale factor annotation. This issue may result in
a potential miscalculation of size.
PRODUCT :
Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit",
"Xenon Circuit", and Needleless Xenon Diagnostic Circuit" Manufactured
for RAF MEDICAL, INC., (Model number's RAF2306, RAF2304, RAF2380,
RAF2300, RAF2370, RAF2372, RAF2350, RAF2341, RAF2302, RAF2340 RAF2306,
RAF2304, RAF2361), or Medico-Mart, Inc. ("Xenon Curcuit" Model number's
2304, 2306). Xenon Diagnostic Circuit Kit: Used in specific Nuclear
Medicine Procedures. ViroMax: For use on all patient populations, in
conjunction with other respiratory devices containing standard 15 mm
and/or 22 mm fittings (such as breathing circuits and the like) to
filter respiratory gases where infection from airborne bacteria and
viruses is a concern. Recall # Z-1754-2010
MANUFACTURER: Continental Medical Labs, Inc., Waterford, WI, by letters
one dated March 31, 2010 and the other dated April 7, 2010. Firm
initiated recall is ongoing.
REASON: A component of the Xenon Kit (ViroMax viral and bacterial
filter) is being recalled because the filters may have a leak at the
seam where the two halves of the filter are bonded together.
PRODUCT :
The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool
Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1
Pain Management Tube Kit. Model/Catalogue Number: LUK-17-150-4 The
LumbarCool Pain Management System, a cooled radiofrequency pain
management system, in combination with the Baylis Pain Management
Generator-TD (PMG-TD), is indicated for use to create RF lesions in
nervous tissue. Recall # Z-1755-2010
MANUFACTURER: Recalling Firm: Baylis Medical Corp *, Montreal, Canada,
by letter dated May 12, 2010. Manufacturer: Baylis Medical Company Inc.,
Mississauga Ontario, Canada. Firm initiated recall is ongoing.
REASON: Name of the device reflected on the product packing sleeve is
incorrect.
PRODUCT :
Boston Scientific, Back-Up Meier Steerable Guidewires, Sterilized using
ethylene oxide. The steerable guidewires are made of a stainless-steel,
PTFE-coated proximal shaft, which tapers down to a very flexible and
shapeable distal tip. The tip area consists of a radio-opaque
gold-plated tungsten spring coil wound around a stainless-steel inner
core. The usable length of the guidewire is 185 cm, 260 cm and 300 cm.
Material (UPN) H965SCH306000; Catalog # SCH-30600; Product Description /
Number BACK-UP MEIER .035 in, 185cm FLEX J TIP, Single / Single.
Material (UPN) H965SCH306001; Catalog # SCH-30600; Product Description /
Number BACK-UP MEIER .035 in, 185cm, J TIP B5 /5 per Box. Material (UPN)
H965SCH306010; Catalog # SCH-30601; Product Description / Number BACK-UP
MEIER .035 in, 300cm EX, FLEX C, Single/ Single. Material (UPN)
H965SCH306011; Catalog # SCH-30601; Product Description / Number BACK-UP
MEIER .035 in, 300cm EX C TIP B5/5 per Box. Material (UPN) M001306020;
Catalog # 30-602; Product Description / Number MEIER WIRE 260 cm .035
w/C TIP, SINGLE/Single. Material (UPN) M001306021; Catalog # 30-602;
Product Description / Number MEIER WIRE 260 cm .035 w/C TIP 5 PER BX/5
per Box. Recall # Z-1760-2010
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Maple Grove MN,
letter dated April 19, 2010. Manufacturer: Boston Scientific Corp.,
Miami Fl. Firm initiated recall is ongoing.
REASON: Boston Scientific Corporation is conducting a Medical Device
Recall of certain lots/batches of its Back-up Meier Steerable Guidewires.
Through their internal inspection process, they identified that the
polytetrafluoroethylene (PTFE) coating on the gold plated distal coil of
the Back-up Meier Steerable Guidewires of the identified lots/batches
have the potential for PTFE delamination. Inconsistent adherence of PTFE
coating to this coil portion of the guidewire may cause the PTFE coating
to flake or fall off from delamination. Injury to the brain, kidneys and
other organs could, potentially, be caused if the PTFE coating flakes or
falls off the guidewire and if, consequently, PTFE particulates are
released into the blood stream. In the most severe cases, injuries could
include stroke, irreversible impairment to brain or renal function, blue
toe syndrome and/or other ischemic effects.
PRODUCT :
1) DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 22 cm Straight Basic
Kit, Catalog Number/REF 10302802, 510 (k) 080400, Sterile. Recall #
Z-1761-2010;
2) DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 24 cm Straight Basic
Kit, Catalog Number/REF 10302803, 510 (k) 080400, Sterile. Recall #
Z-1762-2010;
3) DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 28 cm Straight Basic
Kit, Catalog Number/REF 10302804, 510 (k) 080400, Sterile. Recall #
Z-1763-2010;
4) DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 32 cm Straight Basic
Kit, Catalog Number/REF 10302805, 510 (k) 080400, Sterile. Recall #
Z-1764-2010;
5) DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 36 cm Straight Basic
Kit, Catalog Number/REF 10302806, 510 (k) 080400, Sterile. Recall #
Z-1765-2010;
6) DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 40 cm Straight Basic
Kit, Catalog Number/REF 10302807, 510 (k) 080400, Sterile. Recall #
Z-1766-2010;
7) DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 55 cm Straight Basic
Kit, Catalog Number/REF 10302809, 510 (k) 080400, Sterile. Recall #
Z-1767-2010;
8) DURAMAX (TM) Hemodialysis Catheters, Stack Tip 24 cm Pre-Curve Basic
Kit, Catalog Number/REF 10302812, 510 (k) 080400, Sterile. Recall #
Z-1768-2010;
9) DURAMAX (TM) Hemodialysis Catheters, Stack Tip 28 cm Pre-Curve Basic
Kit, Catalog Number/REF 10302813, 510 (k) 080400, Sterile. Recall #
Z-1769-2010;
10) DURAMAX (TM) Hemodialysis Catheters, Stack Tip 32 cm Pre-Curve Basic
Kit, Catalog Number/REF 10302814, 510 (k) 080400, Sterile. Recall #
Z-1770-2010;
11) DURAMAX (TM) Hemodialysis Catheters, Stack Tip 36 cm Pre-Curve Basic
Kit, Catalog Number/REF 10302815, 510 (k) 080400, Sterile. Recall #
Z-1771-2010
MANUFACTURER: Angiodynamics, Inc., Queensbury, NY, by letters dated
January 7, 2010. Firm initiated recall is ongoing.
REASON: The product has the potential for a cross-lumen leak. One of the
two leak testers that are used to perform the leak test on the DuraMax
Catheters was found to be faulty. The tester was not able to detect
cross-lumen leaks. Both testers were used during the manufacturing 100%
leak test.
PRODUCT :
1) Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps
Inner Pouch 240cm, Box 20 UPN/Catalog Number: M00513331. Recall #
Z-1772-2010;
2) Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps
Box 80, 240cm UPN/Catalog Number: M00513334. Recall # Z-1773-2010;
3) Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps
UPN/Catalog Number: MOO513330 The Radial Jaw 4 Large Capacity Inner
Pouch, 240cm UPN M00513330 Is a single unit which Is packaged into a Box
of 20 units (UPN M00513331), and a Box of 80 units (UPN M00513334).
Single packaged units of M00513330 are not sold individually. Recall #
Z-1774-2010
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Marlborough, MA,
by letters on May 6, 2010.Manufacturer: Boston Scientific Corp., El
Coyol, Costa Rica. Firm initiated recall is ongoing.
REASON: Clevis may detach from the coil preventing the device to open
and/or close. Delays in the procedure may result.
PRODUCT :
1) MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator
that provides negative pressure for the application of wound drainage;
Models 769600 (with Truseal), 759600 (refurbished), 769600 Rental,
769601 (rental), 769602 (evaluation pump with Truseal) and 769610 (sales
unit with case). Recall # Z-1777-2010;
2) NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable
Wound Care Pump; Model 769709. Recall # Z-1778-2010
MANUFACTURER: Ohio Medical Corp., Gurnee, IL, by letters dated May 7,
2010 5/10/10, May 13, 2010 and May 14, 2010, and telephone on May 11,
2010. Firm initiated recall is ongoing.
REASON: Ohio Medical has received a report of an explosive event with a
MoblVac Portable Woundcare Pump housing where parts were separated while
in an enclosed nylon transport bag during use.
PRODUCT :
Rayhack Drill Guide Angled, Ref 4010-0206, 1 Each, Rx Only, Non-Sterile,
Intended use: Preparation of the Radius prior to device implantation.
Recall # Z-1779-2010
MANUFACTURER: Wright Medical Technology Inc., Arlington, TN, by letter
on April 8, 2010. Firm initiated recall is ongoing.
REASON: Drill guides from 2 lots may not seat properly on the
compression block.
PRODUCT :
St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model
UW-LP-2, Sterilized with Ethylene Oxide. Single-use. The Ultra Wand LP
device is designed for use with the Epicor Cardiac Ablation System.
Recall # Z-1780-2010
MANUFACTURER: St. Jude Medical Atrial Fibrillation Division Inc.,
Sunnyvale, CA, by letters dated June 15, 2009 and November 6, 2009. Firm
initiated recall is ongoing.
REASON: The firm states that overheating of cardiac tissue is caused by
inadequate cooling. The potential exists when the UltraWand is run using
off-label cooling methods (gravity saline flow instead of N pump) that
cooling flow to one or both cells can be decreased based on pressure
applied by the physician to the device. To reflect this information to
the user, the Atrial Fibrillation Division (AFD) has implemented
revisions to the Instructions for Use (IFU) for the UltraWand LP
Handheld Ablation Device. Five revisions have been made to the IFU.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
June 2, 2010
CLASS II
PRODUCT:
1) Pointe Scientific Iron/TIBC Reagent Set, for the quantitative
determination of serum iron and iron binding capacity, Catalog #s:
I7504-60, I7504-400, I7504-SAM, 10-I7504-60. Clinical chemistry reagent
for the quantitative determination of iron in serum. Recall #
Z-0899-2010;
2) Pointe Scientific Total Iron Reagent Set, for the quantitative
determination of serum iron, Catalog #s: I7505-120, I7505-500. Clinical
chemistry reagent for the quantitative determination of iron in serum.
Recall # Z-0900-2010;
3) Pointe Scientific Iron (Ferrozine) Reagent Set, for the quantitative
determination of serum iron, Catalog #s: HI704-300, HI904-1200,
HI904-498, HI904-600, HI904-SAM-911, HI904-SAM-917 and 12-HI904-144.
Clinical chemistry reagent for the quantitative determination of iron in
serum. Recall # Z-0901-2010;
4) Pointe Scientific Iron (Ferrozine) R1 Reagent Set, for the
quantitative determination of serum iron, Catalog #: HI404-R1. Clinical
chemistry reagent for the quantitative determination of iron in serum.
Recall # Z-0902-2010;
5) Pointe Scientific Iron (Ferrozine) R2 Reagent Set, for the
quantitative determination of serum iron, Catalog #: HI404-R2. Clinical
chemistry reagent for the quantitative determination of iron in serum.
Recall # Z-0903-2010;
6) Pointe Scientific, Inc. Iron Buffer Reagent. Catalog #s:
7-I7504-BUF-1000, 7-I7504-BUF-120, 7-I7504-BUF-75, 8-I7504-BUF-500 and
3-I7504-BUF. Clinical chemistry reagent for the quantitative
determination of iron in serum. Recall # Z-0904-2010;
7) Pointe Scientific, Inc. Iron Color Reagent, Catalog #s:
7-I7504-COL-15, 7-I7504-COL-5, 7-I7504-COL-60, 8-I7504-COL-15,
8-I7504-COL-60 and 3-I7504-COL. Clinical chemistry reagent for the
quantitative determination of iron in serum. Recall # Z-0905-2010;
8) Pointe Scientific Iron Reagent (R2), for the quantitative
determination of serum iron, Catalog #: 8HI904-R2-100. Recall #
Z-0906-2010
MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by letter dated
November 16, 2009. Firm initiated recall is ongoing.
REASON: Turbidity formation could occur, resulting in invalid test
results being reported out.
PRODUCT:
Aquilion One Whole Body X-Ray CT Scanner Whole body computed tomography
scanning. Recall # Z-0907-2010
MANUFACTURER: Toshiba American Medical Systems Inc., Tustin, CA, by
letter on January 7, 2010. Firm initiated recall is ongoing.
REASON: When W-Volume is performed in Prospective CTA or Target CTA
studies with ECG gating, unnecessary intervals may be set before
starting the volume scan. As a result, scanning cannot be performed at
the appropriate timing of constant enhancement and clinically useful
images may not be obtained.
PRODUCT:
1) Lifesign Staph Latex Kits, 6 ml For In Vitro Diagnostic Use Catalog
Number: 50051. A rapid latex agglutination test to detect Protein A
and/or clumping factor for Staph aureus from culture media. Recall #
Z-1110-2010;
2) Wampole Staph Latex Test, 6.0 ml -120 Test Kit For In Vitro
Diagnostic Use Catalog Number: 56D6. A rapid latex agglutination test to
detect Protein A and/or clumping factor for Staph aureus from culture
media. Recall # Z-1111-2010
2) Lot Numbers: 0919119 and 1110049 Exp. Date 06/03/2012
MANUFACTURER: NERL Diagnostics Corp., East Providence, RI, by letter on
January 15, 2010. Firm initiated recall is ongoing.
REASON: Unreactive Staph latex reagent.
PRODUCT:
Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model
number: 7204. Recall # Z-1592-2010
MANUFACTURER: Galt Medical Corp., Garland, TX, by telephone on February
8, 2010 and letter, dated February 10, 2010. Firm initiated recall is
ongoing.
REASON: Potential problem with pouch seal thus affecting sterile
product.
PRODUCT:
Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920.
Intended to be used to centralize the femoral stem within the
intramedullary canal. Intended to be used with bone cement. Recall #
Z-1601-2010
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters
on March 29, 2010. Firm initiated recall is ongoing.
REASON: Stryker became aware that device labels have incorrectly printed
manufacture dates and thus incorrect expiration dates on the product
label.
PRODUCT:
Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part
numbers: MR-FC-2EO, MR-FC-3EO. Recall # Z-1616-2010
MANUFACTURER: Recalling Firm: Hitachi Medical Systems America Inc.,
Twinsburg, OH, by letters on April 15, 2010.
Manufacturer: Hitachi Medical Systems, Kashiwa City, Japan. Firm
initiated recall is ongoing. Japan
REASON: Hitachi determined that the mounting method for a Compensation
Coil did not include an appropriate factor of safety, so it is possible
that the coil could fall, contacting the patient table and potentially
putting a patient at risk.
PRODUCT :
1) Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light),
Catalog numbers: 0682001250, 0682001251. Intended to illuminate the
operative site during surgical procedures with high intensity light.
Recall # Z-1640-2010;
2) Stryker Equipment Delivery System (EDS); Ceiling Mounted Equipment
Booms; Catalog Number: 0682000383, 0682000384, 0682000385(A-D),
0682000386(A-D), 0682000426, 0682000429(A-D), 0682000326, 0682000311,
0682000361, 0682000362, 0682000230, 0682000337, 0682000338, 0682000232,
0682000233, 0682000339, 0682000234, 0682000235, 0682000236, 0682000340,
0682000341, 0682000238, 0682000239, 0682000342, 0682000240, 0682000241,
0682000931, 0682000343, 0682000344, 0682000328, 0682000933, 0682000345,
0682000329, 0682000330, 0682000934, 0682000346, 0682000347, 0682000331,
0682000936, 0682000348, 0682000332, 0682000333, 0682000401, 0682000302,
& 0682000327. The booms are ceiling mounted devices. They are available
in articulating and non-articulating configurations, in single or tandem
(pair) configuration, with different shelves configuration to allow for
various load capacities. Intended for use as ceiling-mounted devices for
supporting or positioning equipment in the surgical suite and/or
delivers gases or electricity to these devices. Recall # Z-1641-2010;
3) Stryker VISUM Halogen Surgical Lights (Ceiling Mounted Surgical
Lights), Catalog Number: 0682000106; 0682000107. Intended to illuminate
the operative site during surgical procedures with high intensity light.
Recall # Z-1642-2010;
4) SwitchPoint Element (SPE) Control System. Control System for
audio/video, surgical, and room equipment. Catalog Numbers: 067000220,
067000230, 067000231, 067000232, 067000233. Used for direct control of
room equipment, audio/video equipment, and indirect control of surgical
equipment in the operating room. Recall # Z-1643-2010;
5) SwitchPoint Infinity (SPI) Control System. Catalog Numbers:
067000220, 067000230, 067000231, 067000232, & 067000233. Used for direct
control of room equipment, audio/video equipment, and indirect control
of surgical equipment in the operating room. Recall # Z-1644-2010;
6) Ceiling Suspensions (Surgical Light and Flat Panel Suspensions);
Catalog Numbers: 0682000863, 06820001009, 0682001010, 0682001076,
0682000864, 0682000857, 0682000858, 0682001077, 0682000865, 0682001011,
0682001078, 0682000866, 0682001012, 0682001080, 0682000867, 0682000959,
0682001079, 0682000850, 0682000851, 0682000852, 0682001269, 0682001567,
0682001569, 0682001570, 06820012691, 06820015671, 06820015691, &
0680015701. The ceiling suspensions are available in different
configurations; they can hold monitors (flat panel suspensions), cameras
(navigation suspensions arms) or surgical lights. The flat panel could
have fixed or adjustable monitor yokes and may be single or dual arm
configuration. Each ceiling suspension could hold a maximum of two
surgical lights and either one camera or one monitor. There may be
multiple ceiling/boom suspensions in an operating room. Intended for use
as ceiling-mounted devices for supporting or positioning surgical
lights, cameras, and/or monitors. Recall # Z-1645-2010
MANUFACTURER: Stryker Communications Corp., Flower Mound, TX, by letter,
dated April 15, 2010. Firm initiated recall is ongoing.
REASON: Installation records are incomplete.
PRODUCT :
Blackstone Medical Inc.,Orthofix Spinal Implants, Hallmark Anterior
Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile.
Part number 62-0070. Recall # Z-1653-2010
MANUFACTURER: Recalling Firm: Blackstone Medical, Inc., Wayne, NJ,
letters on March 29, 2010. Manufacturer: Kmedic, Kenosha, WI, Firm
initiated recall is ongoing.
REASON: The Hallmark Anterior Cervical Plate Bender may have a non
conformity causing difficulty accepting 3-4 level plates or to not
accept 3-4 level plates that are intended to be additionally contoured.
PRODUCT :
Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for
use with the THERAKOS CellEx Instrument. Recall # Z-1654-2010
MANUFACTURER: Therakos, Inc., Raritan, NJ, by letters and telephone on
March 29, 2010, March 31, 2010, April 12, 2010 and May 7, 2010. Firm
initiated recall is ongoing.
REASON: Higher than normal blood leaks on THERAKOS CELLEX Procedural
Kits that is intended for use with the THERAKOS CELLEX Photopheresis
System.
PRODUCT :
Elekta XiO Radiation Treatment Planning System. Recall # Z-1655-2010
MANUFACTURER: Computerized Medical Systems Inc., Maryland Heights, MO,
by letters on April 6, 2010, April 12, 2010 and April 20, 2010. Firm
initiated recall is ongoing.
REASON: Under certain circumstances, XiO will over-estimate dose in the
region where the backup jaw is inside the MLC opening.
PRODUCT :
1) GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ,
Cardiovascular Imaging System (The system consists of a monoplane
positioner, a vascular or cardiac table, an X-ray system and a digital
detector). Recall # Z-1659-2010;
2) GE Healthcare, Innova 3100 IQ: GE Innova 3100 / 3100 IQ,
Cardiovascular Imaging System, (The system consists of a monoplane
positioner, a vascular or cardiac table, an X-ray system and a digital
detector). Recall # Z-1660-2010;
3) GE Healthcare, Innova 2100IQ (The Digital Fluoroscopic Imaging System
consists of an a monoplane positioner, a vascular or cardiac table, an
X-ray system and a digital detector). Recall # Z-1661-2010
MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by
letter dated March 23, 2010.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated
recall is ongoing.
REASON: A potential software failure related to the Worklist
functionality has been identified on a subset of Innova 2100IQ, 3100IQ
and 4100IQ systems. When using the Worklist function to import patient
data to Innova, there are two scenarios that will cause the next exam to
fail and the inability to recall acquired sequences.
PRODUCT :
InSound Medical, Inc, Lyric in-canal hearing aid. Recall # Z-1681-2010
MANUFACTURER: InSound Medical, Inc., Newark, CA, by letter on February
1, 2010. Firm initiated recall is ongoing.
REASON: Manufacturing error could result in electrolyte leakage from the
product's battery.
PRODUCT :
Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product
numbers: a) ASK-01451-BMH; b) ASK-05041-CHC; c) ASK-05041-CHC1; d)
ASK-05041-CHM; e) ASK-05041-HMC; f) ASK-05041-QV; g) ASK-07041-BMH; h)
CN-05041-LW; i) MSO-01451-UCL; j) MTO-01451-RH; k) PL-05041; l)
PR-04041-HPX; m) PR-05041; n) PR-05041-HP; o) PR- 05041-HPX; p)
PR-05041-LW; q) PR-05041-MW; r) PR-05041-T; s) PR-05042; t)
PR-05541-HPX; u) PR-07041-PTSP; and v) RJ-01451-W. Recall # Recall #
Z-1682-2010
MANUFACTURER: Arrow International Inc., Reading, PA, by letter dated
March 29, 2010. Firm initiated recall is ongoing.
REASON: Tight fit in sheath. Arrow has received complaints of the PICC
catheter fitting too tightly in the "kit supplied" peelable sheath. In
some cases, clinicians have been unable to insert the catheter through
the peelable sheath during the insertion procedure. If the catheter will
not pass through the sheath, the clinician is required to place a guide
wire back into the sheath, remove the sheath, and place another sheath
that the catheter will pass through. This may delay the procedure and/or
increase the need for a repeat procedure. Risks associated with delay
and/or repeat procedure may include bleeding and infection.
PRODUCT :
1) Juxta-Lite compression wrap Large Short 28cm Length with Anklet
Catalog 23025017. Recall # Z-1684-2010;
2) Juxta-Lite compression wrap Medium Short 28cm Length with Anklet
Catalog 23024017. Recall # Z-1685-2010;
3) Juxta-Lite compression wrap XL Short 28cm Length with Anklet Catalog
23026017. Recall # Z-1686-2010;
4) Juxta-Lite compression wrap XL Full Calf Short 28cm Length with
Anklet Catalog 23026117. Recall # Z-1687-2010;
5) Juxta-Lite compression wrap Large Full Calf Short 28cm Length with
Anklet Catalog 23025117. Recall # Z-1688-2010;
6) Juxta-Lite compression wrap XXLShort 28cm Length with Anklet Catalog
23027017. Recall # Z-1689-2010;
7) Juxta-Lite compression wrap XL Long 33cm Length with Anklet Catalog
23036017.
Recall # Z-1690-2010;
8) Juxta-Lite compression wrap XL Full Calf Long 33cm Length with Anklet
Catalog 23036117. Recall # Z-1691-2010;
9) Juxta-Lite compression wrap Medium Short 28cm Length with Separate
Small AFW Catalog 23124017. Recall # Z-1692-2010;
10) Juxta-Lite compression wrap Large Short 28cm Length with Separate
Small AFW Catalog 23125017. Recall # Z-1693-2010;
11) Juxta-Lite compression wrap XLShort 28cm Length with Separate Small
AFW Catalog 23126017. Recall # Z-1694-2010;
12) Juxta-Lite compression wrap XL Full Calf Short 28cm Length with
Separate Small AFW Catalog 23126117. Recall # Z-1695-2010;
13) Juxta-Lite compression wrap Medium Short 28cm Length with Separate
Medium AFW Catalog 23134017. Recall # Z-1696-2010;
14) Juxta-Lite compression wrap Large Short 28cm Length with Separate
Medium AFW Catalog 23135017. Recall # Z-1697-2010;
15) Juxta-Lite compression wrap XL Full Calf Short 28cm Length with
Separate Medium AFW Catalog 23136117. Recall # Z-1698-2010;
16) Juxta-Lite compression wrap XXL Short 28cm Length with Separate
Medium AFW Catalog 23137017. Recall # Z-1699-2010;
17) Juxta-Lite compression wrap XL Full Calf Long 33cm Length with
Separate Small AFW Catalog 23226117. Recall # Z-1700-2010;
18) Juxta-Lite compression wrap XL Long 33cm Length with Separate Medium
AFW Catalog 23236017. Recall # Z-1701-2010;
19) Juxta-Lite compression wrap XL Full Calf Long 33cm Length with
Separate Medium AFW Catalog 23236117. Recall # Z-1702-2010
MANUFACTURER: Circaid Medical Products Inc., San Diego, CA, by letter
dated April 20, 2010. Firm initiated recall is ongoing.
REASON: Some systems in these lots have Built-In Pressure System lines
with the incorrect amount of spacing. Some systems in these lots had I
inch space between each line with no tension applied. The system should
have 1.25 inches of space. The correct spacing (1.25") is necessary to
achieve the measured tension ranges. The incorrect spacing may result in
the inability to achieve the correct tension level or discomfort from
overtightened bands.
PRODUCT :
S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head.
Recall # Z-1703-2010
MANUFACTURER: 3m Imtec Corp., Ardmore, OK, by telephone on May 14, 2010
and by letter dated May 14, 2010. Firm initiated recall is ongoing.
REASON: Product has Incorrect size Labeling. Actual length is 13mm. One
label is correct, and one states 10mm.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
May 26, 2010
CLASS II
PRODUCT
PM1000 Flow Selector - An accessory to an emergency ventilator
(resuscitator). The selector is attached to a flowmeter and is used to
direct the outlet flow from any standard flowmeter to any one of the
three outlets it provides. Recall # Z-1561-2010
MANUFACTURER: Precision Medical, Inc., Northampton, PA, by letters on
March 5, 2010. Firm initiated recall is ongoing.
REASON
The on/off outlet is mislabeled so that when a user/operator turns
selector to "on", it actually may be turned "off".
PRODUCT
1) Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 3; XCelerate
cutting block for distal femur in orthopaedic surgery, Non Sterile.
Catalog number: 8000-0003. Recall # Z-1574-2010;
2) Stryker Orthopedics, Scorpio Ceramic 4:1 Guide Size 4; XCelerate
cutting block for distal femur in orthopedic surgery, Non Sterile.
Catalog number: 8000-0004. Recall # Z-1575-2010;
3) Stryker Orthopedics, Scorpio Ceramic 4:1 Guide Size 5; XCelerate
cutting block for distal femur in orthopaedic surgery, Non Sterile.
Catalog Number: 8000-0005. Recall # Z-1576-2010;
4) Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 6; XCelerate
cutting block for distal femur in orthopaedic surgery, Non Sterile.
Catalog number: 8000-0006. Recall # Z-1577-2010;
5) Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 7; XCelerate
cutting block for distal femur in orthopaedic surgery, Non Sterile.
Catalog number: 8000-0007. Recall # Z-1578-2010;
6) Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 8; XCelerate
cutting block for distal femur in orthopaedic surgery, Non Sterile.
Catalog number: 8000-0008. Recall # Z-1579-201;
7) Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 9; XCelerate
cutting block for distal femur in orthopaedic surgery, Non Sterile.
Catalog number: 8000-0009. Recall # Z-1580-2010;
8) Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 11; XCelerate
cutting block for distal femur in orthopaedic surgery, Non Sterile.
Catalog number: 8000-0011. Recall # Z-1581-2010;
34
9) Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 13; XCelerate
cutting block for distal femur in orthopaedic surgery, Non Sterile.
Catalog number: 8000-0013. Recall # Z-1582-2010;
10) Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XS;
XCelerate cutting block for distal femur in orthopaedic surgery,
Non-Sterile. Catalog Number: 8000-7005. Recall # Z-1583-2010;
11) Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block SM;
XCelerate cutting block for distal femur in orthopaedic surgery,
Non-Sterile. Catalog number: 8000-7010. Recall # Z-1584-2010;
12) Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block MED;
XCelerate cutting block for distal femur in orthopaedic surgery,
Non-Sterile. Catalog number: 8000-7020. Recall # Z-1585-2010;
13) Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block ML;
XCelerate cutting block for distal femur in orthopaedic surgery,
Non-Sterile. Catalog number: 8000-7030. Recall # Z-1586-2010;
14) Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block LG;
XCelerate cutting block for distal femur in orthopaedic surgery,
Non-Sterile. Catalog number: 8000-7040. Recall # Z-1587-2010;
15) Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XL;
XCelerate cutting block for distal femur in orthopaedic surgery,
Non-Sterile. Catalog number: 8000-7050. Recall # Z-1588-2010;
16) Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XXL;
XCelerate cutting block for distal femur in orthopaedic surgery,
Non-Sterile. Catalog number: 8000-7060. Recall # Z-1589-2010
REASON: The ceramic guide rails, within the XCelerate 4:1 Ceramic
Cutting Blocks, may fracture and displace from the block.
PRODUCT
35
1) Stryker Orthopaedics, Accolade Distal Centralizer 14 mm Large;
Catalog No.: 1059-6714. For use with Accolade hip prosthesis. Recall #
Z-1593-2010;
2) Stryker Orthopaedics, Accolade Distal Centralizer 13 mm Medium;
Catalog No.: 1059-4513. For use with Accolade hip prosthesis. Recall #
Z-1594-2010
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters
on March 31, 2010 and on April 1, 2010. Firm initiated recall is
ongoing.
REASON: One lot of 13 mm medium distal ring centralizers and 14 mm large
distal ring centralizer have been labeled incorrectly. The size 14 Large
centralizers have been labeled as size 13 Medium centralizers and size
13 Medium centralizers have been labeled as size 14 Large centraliizers.
PRODUCT
Basic Core Pack # OR1805, Sterile, Tri State Hospital Supply Corporation
Manufacturers of Centurion Healthcare Products. Recall # Z-1595-2010
MANUFACTURER: Recalling Firm: Centurion Medical Products, Howell, MI, by
letter on April 9, 2010.Manufacturer: Centurion Medical Products Corp.,
Yuma, AZ. Firm initiated recall is ongoing.
REASON: The firm is conducting a sub recall of kits containing ConMed
Goldline Rocker Switch Pencils. The pencils activation switch may remain
in the "on" position after the switch has been depressed with excessive
force, thereby continuously activating the pencil.
PRODUCT
Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the
licensing of CT lung or CT Colon. Recall # Z-1600-2010:
MANUFACTURER: Vital Images, Inc., Plymouth, MN, by letter dated 23
February 2010. Firm initiated recall is ongoing.
REASON: 36
Vital images, Inc is issuing a recall notice on their medical device
software in the use of CT Lung and CT Colon in Vitrea 5.1, Vitrea fX 3.0
or Vitre Enterprise Suite 1.2., because incorrect measurements may
result.
PRODUCT
1) Endotec, Prosthesis Knee, Patellofemorotibial, Semi-Constrained,
Cemented, Polymer/Metal/Polymer, Titanium Alloy, Sterilized, (Beuchel-Pappas
(BP)) The B-P Knee Replacement System is composed of several components
used to provide surgeons with different intra-operative options. All
metallic components are available in six sizes and are fabricated from
Ti-6Al-4V titanium alloy by Endotec. BP Knee Replacement System
Component, Modular Femoral Component: Size 5 Left Modular Femoral
Component, Catalog: 04-31-2105, Lot No. 04-31-2105A; Size 4 Left Modular
Femoral Component, Lot No. 04-31-2104A, Size 6 Left Femoral Component,
Lot No. 04-31-2106A1. BP Knee Replacement System Component, Narrow
Femoral Component: Size 3 Right Narrow Femoral Component Lot No.
04-31-1303C, Size 3 Left Narrow Femoral Component Lot No. 04-31-2303C,
Size 4 Right Narrow Femoral Component Lot No. 04-31-1304C, Size 4 Left
Narrow Femoral Component Lot No. 04-31-2304C. BP Knee Replacement System
Component, All Poly Patella: Size 1 All Poly Patella Lot No.
04-34-0201B, 04-34-0201C, 04-34-0201D, 04-34-0201E. Size 2 All Poly
Patella Lot No. 04-34-0202B, 04-34-0202C, 04-34-0202D, 04-03-0202E. BP
Knee Replacement System Component, 3 Peg Patella: Size 4 3-Peg Patella
Lot No. 04-34-0004H. BP Knee Replacement System Component, Conforming
Bearing: 1x0mm Conforming Bearing Catalog: 04-33-001, 1x2.5mm Conforming
Bearing Catalog: 04-33-0011, 1x5mm Conforming Bearing Catalog:
04-33-0021, 1x7.5mm Conforming Bearing Catalog: 04-33-0031, 2x0mm
Conforming Bearing Catalog: 04-33-0002, 2x2.5mm Conforming Bearing
Catalog: 04-33-0012, 2x5mm Conforming Bearing Catalog: 04-33-0022,
2x7.5mm Conforming Bearing Catalog: 04-33-0032, 3x0mm Conforming Bearing
Catalog: 04-33-0003, 3x2.5mm Conforming Bearing Catalog: 04-33-0013,
3x5mm Conforming Bearing Catalog: 04-33-0023, 3x7.5mm Conforming Bearing
Catalog: 04-33-0033, 4x0mm Conforming Bearing Catalog: 04-33-0004,
4x2.5mm Conforming Bearing Catalog: 04-33-0014, 4x5mm Conforming Bearing
Catalog: 04-33-0024, 4x7.5mm Conforming Bearing Catalog: 04-33-0034,
5x0mm Conforming Bearing Catalog: 04-33-0005, 5x2.5mm Conforming Bearing
Catalog: 04-33-0015 5x5mm Conforming Bearing Catalog: 04-33-0025,
5x7.5mm Conforming Bearing Catalog: 04-33-0035, 6x0mm Conforming Bearing
Catalog: 04-33-0006, 6x2.5mm Conforming Bearing Catalog: 04-33-0016, BP
Knee Replacement System Component, Screw Stop: Size 4-6 Screw Stop
Catalog: 03-12-0036. BP Knee Replacement System Component, Tibial
Component Type 1 w/o Biocoat: Size 1 Type 1 Tibial Component w/o Biocoat
Catalog: 04-32-0401, Size 2 Type 1 Tibial Component w/o Biocoat Catalog:
04-32-0402, Size 3 Type 1 Tibial Component w/o Biocoat Catalog:
04-32-0403, Size 4 Type 1 Tibial Component w/o Biocoat Catalog:
04-32-0404, Size 5 Type 1 Tibial Component w/o Biocoat Catalog:
04-32-0405, Size 6 Type 1 Tibial Component w/o Biocoat Catalog:
04-32-0406. BP Knee Replacement System Component, Tibial Component Type
1: Size 1 Type 1 Tibial Component Catalog: 04-32-0001, Size 3 Type 1
Tibial Component Catalog: 04-32-0003, Size 4 Type 1 Tibial Component
Catalog: 04-32-0004. BP Knee Replacement System Component, Tibial
Component Type 2: Size 3 Type 2 Tibial Component Catalog: 04-32-0013. BP
Knee Replacement 37 System Component, Tibial Component Type 0: Size 5
Type 0 Tibial Platform Catalog: 04-32-0065. BP Knee Replacement System
Component, Femoral Component w/o Biocoat: Size 1 Right Femoral Component
w/o Biocoat Catalog: 04-31-1201, Size 1 Left Femoral Component w/o
Biocoat Catalog:04-31-2201, Size 2 Right Femoral Component w/o Biocoat
Catalog: 04-31-1202, Size 2 Left Femoral Component w/o Biocoat
Catalog:04-31-2202, Size 3 Right Femoral Component w/o Biocoat
Catalog:04-31-1203, Size 3 Left Femoral Component w/o Biocoat
Catalog:04-31-2203, Size 4 Right Femoral Component w/o Biocoat
Catalog:04-31-1204, Size 4 Left Femoral Component w/o Biocoat Catalog:
04-31-2204, Size 5 Right Femoral Component w/o Biocoat Catalog:
04-31-1205, Size 5 Left Femoral Component w/o Biocoat Catalog:
04-31-2205, Size 6 Right Femoral Component w/o Biocoat Catalog:
04-31-1206, Size 6 Left Femoral Component w/o Biocoat Catalog:
04-31-2206. BP Knee Replacement System Component, Femoral Component:
Size 3 Right Femoral Component Catalog: 04-31-1003, Size 3 Left Femoral
Component Catalog: 04-31-2003, Size 4 Right Femoral Component Catalog:
04-31-1004, Size 5 Left Femoral Component Catalog: 04-31-2005, Size 6
Right Femoral Component Catalog: 04-31-1006. Size 1 Universal Tibial
Component Catalog: 04-22-0001. Recall # Z-1621-2010;
2) Endotec Prosthesis Shoulder, Titanium Alloy, Sterilized Modular
Femoral Stem BP Shoulder Component: 12mm Modular Femoral Stem, Catalog:
02-21-0103. Recall # Z-1622-2010;
3) Endotec Prothesis Hip, Titanium Alloy, Sterilized. Acetabular
Bearing, BP Hip System Component: 32x54 Acetabular Bearing, Catalog:
01-02-3254, 32x56 Acetabular Bearing, Catalog: 01-02-3256, Femoral Head
Resurfacing Component, BP Hip System Component: 36.5mm Femoral Head
Resurfacing Component:, Catalog: 01-03-0036, 38mm Femoral Head
Resurfacing Component:, Catalog: 01-03-0038, 39.5mm Femoral Head
Resurfacing Component:, Catalog: 01-03-0039, 41mm Femoral Head
Resurfacing Component:, Catalog: 01-03-0041, 42.5mm Femoral Head
Resurfacing Component:, Catalog: 01-03-0042, 44mm Femoral Head
Resurfacing Component:, Catalog: 01-03-0044, 45.5mm Femoral Head
Resurfacing Component:, Catalog: 01-03-0045, 47mm Femoral Head
Resurfacing Component:, Catalog: 01-03-0047, 49mm Femoral Head
Resurfacing Component:, Catalog: 01-03-0049, 51mm Femoral Head
Resurfacing Component:, Catalog: 01-03-0051, 52mm Femoral Head
Resurfacing Component:, Catalog: 01-03-0052. Femoral Stem BP Hip System
Component: 10mm Femoral Stem Catalog: 01-04-0110, 11mm Femoral Stem
Catalog: 01-04-0111, 12mm Femoral Stem Catalog: 01-04-0112. Recall #
Z-1623-2010;
4) Endotec Prothesis Ankle, Titanium Alloy, Sterilized. BP Ankle System,
Talar Ankle Component: Size 2 Talar Component Catalog: 05-01-0002, Size
3 Talar Component Catalog: 05-01-0003, Size 4 Talar Component Catalog:
05-01-0004, Size 5 Talar Component Catalog: 05-01-0005, BP Ankle System,
Thick Talar Ankle Component: Size 2 Thick Talar Component Catalog:
05-11-0002, Size 3 Thick Talar Component Catalog: 05-11-0003, Size 5
Thick Talar Component Catalog: 05-11-0005, B-P Ankle System, Tibial
Component: Size 2 Tibial Component 05-03-0002, Size 3 Tibial Component
05-03-0003, Size 4 Tibial Component 05-03-0004, Size 5 Tibial Component
05-03-0005. Recall # Z-1624-2010;
5) Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System.
BP Ankle System, F-P Type III Ankle Bearing Component: 2x5mm F-P Type
III Ankle Bearing Catalog: 05-13-0532, 2x7mm F-P Type III Ankle Bearing
Catalog: 05-13-0732, 8x3mm F-P Type III Ankle Bearing 38 Catalog:
05-13-0533, 8x1mm F-P Type III Ankle Bearing Catalog: 05-13-0731. BP
Ankle System, F-P Type III Tibial Ankle Component: Size 1 F-P Type III
Tibial Component Catalog: 05-12-0031, Size 2 F-P Type III Tibial
Component Catalog: 05-12-0032, Size 3 F-P Type III Tibial Component
Catalog: 05-12-0033. BP Ankle System, F-P Type III Talar Component: Size
1 F-P Type III Talar Component Catalog: 05-01-0031, Size 2 F-P Type III
Talar Component Catalog: 05-01-0032, Size 3 F-P Type III Talar Component
Catalog: 05-01-0033. Recall # Z-1625-2010;
6) TMJ Components: Right Ramus Component - DelCristo Catalog:
09-11-0215, TMJ - Shah Catalog: 09-42-0217, 09-11-0217. Left Fossa
Component - DelCristo Catalog 09-42-0216, Left Ramus Component -
DelCristo Catalog: 09-11-0216. Recall # Z-1626-2010;
7) Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System.
BP Ankle System, B-P Type II Talar Ankle Component: Size 1 B-P Type II
Talar Ankle Component Catalog: 05-01-0101, Size 2 B-P Type II Talar
Ankle Component Catalog: 05-01-0102, Size 3 B-P Type II Talar Ankle
Component Catalog: 05-01-0103, Size 4 B-P Type II Talar Ankle Component
Catalog: 05-01-0104, Size 5 B-P Type II Talar Ankle Component Catalog:
05-01-0105, Size 6 B-P Type II Talar Ankle Component Catalog:
05-01-0106. BP Ankle System, BP Type II Ankle Bearing: 3x5mm BP Type II
Ankle Bearing Catalog: 05-02-0103, 3x6mm BP Type II Ankle Bearing
Catalog: 05-02-0113, 3x7mm BP Type II Ankle Bearing Catalog: 05-02-0123,
3x9mm BP Type II Ankle Bearing Catalog: 05-02-0143, 3x11mm BP Type II
Ankle Bearing Catalog: 05-02-0163, 3x13mm BP Type II Ankle Bearing
Catalog: 05-02-0183, 4x5mm BP Type II Ankle Bearing Catalog: 05-02-0104,
4x6mm BP Type II Ankle Bearing Catalog: 05-02-0114, 4x7mm BP Type II
Ankle Bearing Catalog:05-02-0124, 5x5mm BP Type II Ankle Bearing
Catalog: 05-02-0105, 5x7mm BP Type II Ankle Bearing Catalog: 05-02-0125,
5x9mm BP Type II Ankle Bearing Catalog: 05-02-0145. 5x6mm BP Type II
Ankle Bearing Catalog 05-02-0106. 6x5mm BP Type II Ankle Bearing Catalog
05-02-0115. 6x6mm BP Type II Ankle Bearing Catalog 05-02-0116. 7x6mm BP
Type II Ankle Bearing Catalog 05-02-0126. 9x6mm BP Type II Ankle Bearing
Catalog 05-02-0146. 11x5mm BP Type II Ankle Bearing Catalog 05-02-0165.
11x6mm BP Type II Ankle Bearing Catalog 05-02-0166. 13x5mm BP Type II
Ankle Bearing Catalog 05-02-0185. 13x6mm BP Type II Ankle Bearing
Catalog 05-02-0186. BP Ankle System, B-P Type II Tibial Ankle Component
Size 1 B-P Type II Tibial ankle Component Catalog: 05-03-0101, Size 2
B-P Type II Tibial ankle Component Catalog: 05-03-0102, Size 3 B-P Type
II Tibial ankle Component Catalog: 05-03-0103, Size 4 B-P Type II Tibial
ankle Component Catalog: 05-03-0104, Size 5 B-P Type II Tibial ankle
Component Catalog: 05-03-0105, Size 6 B-P Type II Tibial ankle Component
Catalog: 05-03-0106. Recall # Z-1627-2010
MANUFACTURER: Endotec, Inc., Orlando, FL, by letters on June 7, 2009.
Firm initiated recall is Ongoing.
REASON: Products are recalled due to sterility issues involving
validation, process variations and test results.
PRODUCT
Boston Scientific, LATITUDE Communicator, Models 6476 (USA) and 6468
(OUS). Recall # Z-1631-2010
MANUFACTURER: Recalling Firm: Boston Scientific CRM Corp, St. Paul, MN,
by letter dated September 9, 2009.
Manufacturer: Plexus Electronic Assembly, Penang, Malaysia. Firm
initiated recall is ongoing.
REASON: Boston Scientific has determined that alert conditions for a
limited subset of out-of-range Daily Measurements related to leads may
not be recognized by Model 6476 (United States) or Model 6468 (Europe)
LATITUDE in-home communicators. If a communicator fails to recognize a
valid alert situation, notification for this or subsequent alerts for
the same test will not be displayed for physician review on the LATITUDE
Website. However, Daily Measurement values uploaded from the implanted
defibrillator will be available from the ALL PATIENTS page after
completion of the next full device interrogation, which occurs during
Weekly Device Alert Interrogations and scheduled remote follow-ups.
Although a limited subset of alerts may not display on the LATITUDE
Website, it is important to note that all Daily Measurement tests within
the implanted defibrillator function normally, and results will be
displayed as designed when the defibrillator is interrogated with a
programmer. The observed rate for a missed Red Alert (highest priority)
has been approximately 0.01% per month of monitoring. No patient deaths
or injuries have been associated with this communicator behavior.
PRODUCT
1) Leica Footswitch, Type B used in conjunction with Leica Surgical
Microscopes - Models M620, M844/820, M525 and M720; There are three
cable connection footswitch models: a) MFS11, stock number 10445599, a 6
function footswitch type B with cross pedals; b) MFS12, stock number
10445600, a 12 function footswitch type B with cross pedals, XY-actuator
10717602 and screw 10630134 for dust protection enclosed; c) MFS18,
stock number 10448164, a 16 function footswitch type B with cross
pedals, XY-actuator 10717602 and screw 10630134 for dust protection
enclosed. Recall # Z-1632-2010;
2) Leica Wireless Footswitch, Type B used in conjunction with Leica
Surgical Microscopes - Models M620, M844/820, M525 and M720; There are
two wireless models: a) MFS20, stock number 10448406, a 12 function
wireless footswitch type B with cross pedals, XY-actuator 10717602 and
screw 10630134 for dust protection enclosed; b) MFS21, stock number
10448407, a 16 function wireless footswitch type B with cross pedals,
XY-actuator 10717602 and screw 10630134 for dust protection enclosed.
Recall # Z-1633-2010
MANUFACTURER: Leica Microsystems, Inc., Bannockburn, IL, by letters
dated March 29, 2010. Manufacturer: Leica Microsystems (Schweiz) Ag,
Heerbrugg, Switzerland. Firm initiated recall is ongoing.
REASON: The pedals of the Footswitch Type B stick and the Zoom/Focus
moves to the end position.
CLASS III
PRODUCT
One Touch Ping Insulin Pump using ezManager Max diabetes management
software. Recall # Z-1560-2010
MANUFACTURER: Animas Corp., West Chester, PA, by letter dated December
22, 2009. Firm initiated recall is ongoing.
REASON: Software malfunction which disallows users to download, view and
print information from their pump (including blood glucose, insulin
delivery, carbohydrate and pump events). Additionally, users are unable
to customize the built-in food database and pump settings using the
software.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
May 19, 2010
CLASS II
PRODUCT:
1) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev
A, ABB System Kit (Orange) Pack NAV, Abbott Item Number 70684-01.
Medical device indicated for continually recording interstitial fluid
glucose levels in people ages 18+ with diabetes mellitus for improving
diabetes management. The device is indicated to be used in hospital and
home settings to aid health care. Recall # Z-0820-2010;
2) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev
A, System Kit Packaging Orange, Abbott Item Number 70684-02. Medical
device indicated for continually recording interstitial fluid glucose
levels in people ages 18+ with diabetes mellitus for improving diabetes
management. The device is indicated to be used in hospital and home
settings to aid health care. Recall # Z-0821-2010;
3) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev
A, System Kit Packaging, Abbott Item Number 70684-03. Medical device
indicated for continually recording interstitial fluid glucose levels in
people ages 18+ with diabetes mellitus for improving diabetes
management. The device is indicated to be used in hospital and home
settings to aid health care. Recall # Z-1444-2010;
4) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev
A, ABB Warranty Kit Xmitter Nav, Abbott Item Number 70791-01. Medical
device indicated for continually recording interstitial fluid glucose
levels in people ages 18+ with diabetes mellitus for improving diabetes
management. The device is indicated to be used in hospital and home
settings to aid health care. Recall # Z-1445-2010;
5) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev
A, Replacement Kit, Transmitter, Abbott Item Number 70791-02. Medical
device indicated for continually recording interstitial fluid glucose
levels in people ages 18+ with diabetes mellitus for improving diabetes
management. The device is indicated to be used in hospital and home
settings to aid health care. Recall # Z-1446-2010;
6) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev
A, Reorder/Warranty Kit EMEA, Abbott Item Number 70791-20. Medical
device indicated for continually recording interstitial fluid glucose
levels in people ages 18+ with diabetes mellitus for improving diabetes
management. The device is indicated to be used in hospital and home
settings to aid health care. Recall # Z-1447-2010;
7) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev
A, ABB System Kit MG, EMEA, DE. Abbott Item Number 70965-01, Medical
device indicated for continually recording interstitial fluid glucose
levels in people ages 18+ with diabetes mellitus for improving diabetes
management. The device is indicated to be used in hospital and home
settings to aid health care. Recall # Z-1448-2010;
8) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev
A, System Kit Business I, MG, (E). Abbott Item Number 70965-02. Medical
device indicated for continually recording interstitial fluid glucose
levels in people ages 18+ with diabetes mellitus for improving diabetes
management. The device is indicated to be used in hospital and home
settings to aid health care. Recall # Z-1449-2010;
9) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev
A, System Kit Business I, MG, and System Kit MG (EMEA) FR, Pack. Abbott
Item Number 70965-03. Medical device indicated for continually recording
interstitial fluid glucose levels in people ages 18+ with diabetes
mellitus for improving diabetes management. The device is indicated to
be used in hospital and home settings to aid health care. Recall #
Z-1450-2010;
10) Freestyle Navigator Continuous Glucose Monitor System, ABB NAV Dutch
System Kit CE RE, AND ABB SYSTEM KIT, MMOL, EMEA AND ABB09 Dutch Kit New
LCD. Abbot Item Number 70966-01. Medical device indicated for
continually recording interstitial fluid glucose levels in people ages
18+ with diabetes mellitus for improving diabetes management. The device
is indicated to be used in hospital and home settings to aid health
care. Recall # Z-1451-2010;
11) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev
A, System, Business 1, MMOL. Abbott Item Number 70966-02. Medical device
indicated for continually recording interstitial fluid glucose levels in
people ages 18+ with diabetes mellitus for improving diabetes
management. The device is indicated to be used in hospital and home
settings to aid health care. Recall # Z-1452-2010;
12) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev
A, System, Business 1, MMOL (EMEA) UK. Abbott Item Number 70966-03.
Medical device indicated for continually recording interstitial fluid
glucose levels in people ages 18+ with diabetes mellitus for improving
diabetes management. The device is indicated to be used in hospital and
home settings to aid health care. Recall # Z-1453-2010;
13) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev
A, System Kit MMOL (EMEA) SV. Abbott Item Number 70966-04. Medical
device indicated for continually recording interstitial fluid glucose
levels in people ages 18+ with diabetes mellitus for improving diabetes
management. The device is indicated to be used in hospital and home
settings to aid health care. Recall # Z-1454-2010;
14) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev
A, System Kit MMOL EMEA. Abbott Item Number 71036-01. Medical device
indicated for continually recording interstitial fluid glucose levels in
people ages 18+ with diabetes mellitus for improving diabetes
management. The device is indicated to be used in hospital and home
settings to aid health care. Recall # Z-1455-2010;
15) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev
A, System Kit MG EMEA and System Kit MMOL, EMEA. Abbott Item Number
71036-02. Medical device indicated for continually recording
interstitial fluid glucose levels in people ages 18+ with diabetes
mellitus for improving diabetes management. The device is indicated to
be used in hospital and home settings to aid health care. Recall #
Z-1456-2010;
16) Freestyle Navigator Continuous Glucose Monitor System, System Kit,
Business 1, (Orange). Abbott Item Number: PRT 03415-001. Medical device
indicated for continually recording interstitial fluid glucose levels in
people ages 18+ with diabetes mellitus for improving diabetes
management. The device is indicated to be used in hospital and home
settings to aid health care. Recall # Z-1457-2010;
17) Freestyle Navigator Continuous Glucose Monitor System, Clinical
System Kit, Packaging. Medical device indicated for continually
recording interstitial fluid glucose levels in people ages 18+ with
diabetes mellitus for improving diabetes management. The device is
indicated to be used in hospital and home settings to aid health care.
Recall # Z-1458-2010;
18) Freestyle Navigator Continuous Glucose Monitor System, ABB
Transmitter Navigator. Abbott Item Number: PRT 03831-001. Medical device
indicated for continually recording interstitial fluid glucose levels in
people ages 18+ with diabetes mellitus for improving diabetes
management. The device is indicated to be used in hospital and home
settings to aid health care. Recall # Z-1459-2010;
19) Freestyle Navigator Continuous Glucose Monitor System, Assy,
Transmitter Poly Contac, Abbott Item Number: PRT 03831-002. Medical
device indicated for continually recording interstitial fluid glucose
levels in people ages 18+ with diabetes mellitus for improving diabetes
management. The device is indicated to be used in hospital and home
settings to aid health care. Recall # Z-1460-2010;
20) Freestyle Navigator Continuous Glucose Monitor System, Clinical
Transmitter, Abbott Item Number: PRT 03831-091. Medical device indicated
for continually recording interstitial fluid glucose levels in people
ages 18+ with diabetes mellitus for improving diabetes management. The
device is indicated to be used in hospital and home settings to aid
health care. Recall # Z-1461-2010
MANUFACTURER: Recalling Firm: Abbott Diabetes Care, Inc., Alameda, CA,
by letters on April 14, 2009.Manufacturer: Benchmark Electronics,
Rochester, MN. Firm initiated recall is ongoing.
REASON: Potential failure or inaccurate readings--the device's plastic
housing near the battery compartment may crack, and allow moisture to
enter.
PRODUCT:
Precise Treatment Table Intended as a universal patient treatment
support and positioning table for radiation therapy and simulation use.
Recall # Z-1432-2010
MANUFACTURER: Recalling Firm: Elekta, Inc., Norcross, by a Mandatory
Field Change Order (FCO) 528 053, dated January 11, 2007.
Manufacturer: Elekta Oncology Systems (Fmrl Philipps, Crawley, West
Sussex, United Kingdom. Firm initiated recall is ongoing.
REASON: In some instances, the bolts which are supplied with the table
have sheared off, resulting in inability to operate the powered table
PRODUCT
3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm.
Intended to aid the surgeon in relieving the patient of knee pain and
restoring knee joint function. Catalog Number: 392-11-604. Recall #
Z-1433-2010
MANUFACTURER: Encore Medical, LP. Austin, TX, by e-mail dated March 19,
2010. Firm initiated recall is ongoing.
REASON: Affected product had incorrect color label which is a secondary
visual indicator for sizing.
PRODUCT:
Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P,
20P, 30P and 40P. Intended as an accessory to the Ascension PyroCarbon
PIP Total Joint used in finger joint implant procedures where the joint
has become painful, stiff or cannot move because of arthritis. Recall #
Z-1524-2010
MANUFACTURER: Ascension Orthopedics, Inc., Austin, TX, by e-mail
beginning June 2009. Firm initiated recall is ongoing.
REASON: Trial product was larger than actual implant. Trial product was
re-designed to more closely match the implant.
PRODUCT:
PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable
6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter,
BARD Access Systems Assembled in Mexico Indicated for patient therapies
requiring repeated access to the vascular system for the infusion of
medications, I.V. fluids, parenteral nutrition solutions, blood products
and blood sample withdrawals. REF#1806061. Recall # Z-1525-2010
MANUFACTURER: Bard Access Systems, Salt Lake City, UT, letter dated
March 18, 2010. Firm initiated recall is ongoing.
REASON: 8F PowerPort stems were mixed with 6F PowerPorts and packaged.
PRODUCT:
Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for
the calibration of ammonia (AMON), Carbon Dioxide (CO2) and Ethyl
Alcohol (ETOH) on the Dimension Vista System. Catalog number KC130.
Recall # Z-1535-2010
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by
letter dated October 2009. Firm initiated recall is ongoing.
REASON: Patient results are depressed.
PRODUCT:
Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Product
Code: 0010211. The Ventrio Hernia Patch is a self-expanding
non-absorbable, sterile prosthesis, containing two primary layers of
monofilament polypropylene mesh stitched with PTFE monofilament to an
ePTFE sheet, forming a positioning pocket. The Ventrio Hernia Patch is
indicated for use in the reconstruction of soft tissue deficiencies,
such as for the repair of hernias. Recall # Z-1536-2010
MANUFACTURER: Davol, Inc., Sub. C. R. Bard, Inc., Warwick, RI, by letter
dated April 8, 2010. Firm initiated recall is ongoing.
REASON: Mislabeled: Product labeled as Small Oval (3.1" x 4.7") may
contain Small Circle (3.0").
PRODUCT:
1) AEM Disposable Electrode, Spatula, 35cm, REF ES0301, Qty: 10 each
Sterile R. Electrosurgical accessories intended, by use of monopolar
high-frequency electrical current from compatible electrosurgical
generators, for ablation, removal, resection and coagulation of soft
tissue where associated hemostasis is required in open, endoscopic and
laparoscopic surgical procedures. Recall # Z-1539-2010;
2) AEM Disposable Electrode, Spatula, 45cm, REF ES0301-45, Qty 10 each
Sterile R. Electrosurgical accessories intended, by use of monopolar
high-frequency electrical current from compatible electrosurgical
generators, for ablation, removal, resection and coagulation of soft
tissue where associated hemostasis is required in open, endoscopic and
laparoscopic surgical procedures. Recall # Z-1540-2010;
3) AEM Disposable Electrode, Flat J-Hook, 35cm, REF ES0309, Qty 10 each
Sterile R. Electrosurgical accessories intended, by use of monopolar
high-frequency electrical current from compatible electrosurgical
generators, for ablation, removal, resection and coagulation of soft
tissue where associated hemostasis is required in open, endoscopic and
laparoscopic surgical procedures. Recall # Z-1541-2010;
4) AEM Disposable Electrode, J-Hook, 35cm, REF ES0310, Qty 10 each
Sterile R. Electrosurgical accessories intended, by use of monopolar
high-frequency electrical current from compatible electrosurgical
generators, for ablation, removal, resection and coagulation of soft
tissue where associated hemostasis is required in open, endoscopic and
laparoscopic surgical procedures. Recall # Z-1542-2010;
5) AEM Disposable Electrode, J-Hook, 45cm, REF ES0310-45.
Electrosurgical accessories intended, by use of monopolar high-frequency
electrical current from compatible electrosurgical generators, for
ablation, removal, resection and coagulation of soft tissue where
associated hemostasis is required in open, endoscopic and laparoscopic
surgical procedures. Recall # Z-1543-2010;
6) AEM Disposable Electrode, L-Diamond, 35cm, REF ES0311, Qty 10 each
Sterile R. Electrosurgical accessories intended, by use of monopolar
high-frequency electrical current from compatible electrosurgical
generators, for ablation, removal, resection and coagulation of soft
tissue where associated hemostasis is required in open, endoscopic and
laparoscopic surgical procedures. Recall # Z-1544-2010;
7) AEM Disposable Electrode, L-Wedge, 35cm, REF ES0312, Qty 10 each
Sterile R. Electrosurgical accessories intended, by use of monopolar
high-frequency electrical current from compatible electrosurgical
generators, for ablation, removal, resection and coagulation of soft
tissue where associated hemostasis is required in open, endoscopic and
laparoscopic surgical procedures. Recall # Z-1545-2010;
8) AEM Disposable Electrode, L-Wedge, 45cm, REF ES0312-45, Qty 10 each
Sterile R. Electrosurgical accessories intended, by use of monopolar
high-frequency electrical current from compatible electrosurgical
generators, for ablation, removal, resection and coagulation of soft
tissue where associated hemostasis is required in open, endoscopic and
laparoscopic surgical procedures. Recall # Z-1546-2010
MANUFACTURER: Encision, Inc., Boulder, CO, by letter dated April 5,
2010. Firm initiated recall is ongoing.:
REASON: Electrosurgical electrode tip insulation may crack and break off
during use.
PRODUCT:
ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software
versions 4.XX, 6.XX and 7.0X. Intended for the purpose of converting
ventricular fibrillation to sinus rhythm or other cardiac rhythms
capable of producing hemodynamically significant heart beats. Recall #
Z-1547-2010
MANUFACTURER: ZOLL Medical Corp., World Wide Headquarters, Chelmsford,
MA, by letter dated March 26, 2010. Firm initiated Recall is ongoing.
REASON: Device issued Shock Advised message but failed to auto-charge
the defibrillator.
PRODUCT:
1) 7.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number 462.723S
Synthes Titanium Solid Humeral Nail System is intended for
intramedullary fixation of a variety of humeral fractures using either
an antegrade or retrograde approach. The indications for the Titanium
Solid Humeral Nail System includes: diaphyseal fractures of the humeral
shaft, fractures of the proximal humerus, proximal humeral fractures
with diaphyseal extension, and impending pathological fractures. Recall
# Z-1548-2010;
2) 7.5mm Ti Solid Humeral Nail 250 mm Sterile Catalog number 462.725S
Synthes Titanium Solid Humeral Nail System is intended for
intramedullary fixation of a variety of humeral fractures using either
an antegrade or retrograde approach. The indications for the Titanium
Solid Humeral Nail System includes: diaphyseal fractures of the humeral
shaft, fractures of the proximal humerus, proximal humeral fractures
with diaphyseal extension, and impending pathological fractures. Recall
# Z-1549-2010
MANUFACTURER: Synthes USA (HQ), Inc., West Chester, PA, by letter dated
February 25, 2010. Firm initiated recall is ongoing.
REASON: Potential compatibility issue.
PRODUCT:
Inion 1.5 x 6mm CPS(R) Baby Screw, 1.5mm Inion CPS(R) Baby 5+E, REF SCR
1221, 5/pack. The INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is a
craniomaxillofacial plating system intended to maintain accurate
alignment of bone fractures and osteotomies in the cranium and mid-face.
Recall # Z-1550-2010
MANUFACTURER: Recalling Firm: Stryker Craniomaxillofacial Division,
Portage, MI, letters, dated March 5, 2010 and March 19, 2010.
Manufacturer: <amifactirer” Inion Ltd. Laakarinkatu 2, Tampere, Finland.
Firm initiated recall is ongoing.
REASON: During a sampling inspection, 2 lots of screws did not meet
shear and torsion testing specifications.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
May 12, 2010
CLASS I
PRODUCT
1) Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 4
DCT, Assembled in Mexico. Intended for bypass of upper airway
obstructions, provide long term ventilation, support and/or manage
tracheal/bronchial secretions. Recall # Z-1462-2010;
2) Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 6
DCT, Assembled in Mexico. Intended for bypass of upper airway
obstructions, provide long term ventilation, support and/or manage
tracheal/bronchial secretions. Recall # Z-1463-2010;
3) Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 8
DCT, Assembled in Mexico. Intended for bypass of upper airway
obstructions, provide long term ventilation, support and/or manage
tracheal/bronchial secretions. Recall # Z-1464-2010;
4) Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 10
DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan
Bennett Division, Pleasanton, CA. Intended for bypass of upper airway
obstructions, provide long term ventilation, support and/or manage
tracheal/bronchial secretions. Recall # Z-1465-2010;
5) Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 FEN,
Assembled in Mexico. Intended for bypass of upper airway obstructions,
provide long term ventilation, support and/or manage tracheal/bronchial
secretions. Recall # Z-1466-2010;
6) Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 FEN,
Assembled in Mexico. Intended for bypass of upper airway obstructions,
provide long term ventilation, support and/or manage tracheal/bronchial
secretions. Recall # Z-1467-2010;
7) Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 FEN,
Assembled in Mexico. Intended for bypass of upper airway obstructions,
provide long term ventilation, support and/or manage tracheal/bronchial
secretions. Recall # Z-1468-2010;
8) Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 FEN,
Assembled in Mexico. Intended for bypass of upper airway obstructions,
provide long term ventilation, support and/or manage tracheal/bronchial
secretions. Recall # Z-1469-2010;
9) Shiley Disposable Cannula Fenestrated Low Pressure Cuffed
Tracheostomy Tube, 4 DFEN, Assembled in Mexico. Intended for bypass of
upper airway obstructions, provide long term ventilation, support and/or
manage tracheal/bronchial secretions. Recall # Z-1470-2010;
10) Shiley Disposable Cannula Fenestrated Low Pressure Cuffed
Tracheostomy Tube, 6 DFEN, Assembled in Mexico. Intended for bypass of
upper airway obstructions, provide long term ventilation, support and/or
manage tracheal/bronchial secretions. Recall # Z-1471-2010;
11) Shiley Disposable Cannula Fenestrated Low Pressure Cuffed
Tracheostomy Tube, 8 DFEN, Assembled in Mexico. Intended for bypass of
upper airway obstructions, provide long term ventilation, support and/or
manage tracheal/bronchial secretions. Recall # Z-1472-2010;
12) Shiley Disposable Cannula Fenestrated Low Pressure Cuffed
Tracheostomy Tube, 10 DFEN, Assembled in Mexico. Intended for bypass of
upper airway obstructions, provide long term ventilation, support and/or
manage tracheal/bronchial secretions. Recall # Z-1473-2010;
13) Shiley Percutaneous Dual Cannula Tracheostomy Tube, 6 PERC,
Assembled in Mexico. Intended for bypass of upper airway obstructions,
provide long term ventilation, support and/or manage tracheal/bronchial
secretions. Recall # Z-1474-2010;
14) Shiley Percutaneous Dual Cannula Tracheostomy Tube, 8 PERC,
Assembled in Mexico. Intended for bypass of upper airway obstructions,
provide long term ventilation, support and/or manage tracheal/bronchial
secretions. Recall # Z-1475-201;
15) Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with
Evacuation Line, 6 FEN-S, Assembled in Mexico. Intended for bypass of
upper airway obstructions, provide long term ventilation, support and/or
manage tracheal/bronchial secretions. Recall # Z-1476-2010;
16) Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with
Evacuation Line, 8 FEN-S, Assembled in Mexico. Intended for bypass of
upper airway obstructions, provide long term ventilation, support and/or
manage tracheal/bronchial secretions. Recall # Z-1477-2010;
17) Shiley Low Pressure Cuffed Tracheostomy Tube, 4 LPC, Assembled in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1478-2010;
18) Shiley Low Pressure Cuffed Tracheostomy Tube, 6 LPC, Assembled in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1479-2010;
19) Shiley Low Pressure Cuffed Tracheostomy Tube, 8 LPC, Assembled in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1480-2010;
20) Shiley Low Pressure Cuffed Tracheostomy Tube, 10 LPC, Assembled in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1481-2010;
21) Shiley Single Cannula Cuffed Tracheostomy Tube, 5 SCT, Assembled in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1482-2010;
22) Shiley Single Cannula Cuffed Tracheostomy Tube, 6 SCT, Assembled in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1483-2010;
23) Shiley Single Cannula Cuffed Tracheostomy Tube, 7 SCT, Assembled in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1484-2010
24) Shiley Single Cannula Cuffed Tracheostomy Tube, 8 SCT, Assembled in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1485-2010;
25) Shiley Single Cannula Cuffed Tracheostomy Tube, 9 SCT, Assembled in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1486-2010;
26) Shiley Single Cannula Cuffed Tracheostomy Tube, 10 SCT, Assembled in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1487-2010
27) Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 4
LPC-S, Assembled in Mexico. Intended for bypass of upper airway
obstructions, provide long term ventilation, support and/or manage
tracheal/bronchial secretions. Recall # Z-1488-2010;
28) Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6
LPC-S, Assembled in Mexico. Intended for bypass of upper airway
obstructions, provide long term ventilation, support and/or manage
tracheal/bronchial secretions. Recall # Z-1489-201;
29) Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8
LPC-S, Assembled in Mexico. Intended for bypass of upper airway
obstructions, provide long term ventilation, support and/or manage
tracheal/bronchial secretions. Recall # Z-1490-2010;
30) Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line,
10 LPC-S, Assembled in Mexico. Intended for bypass of upper airway
obstructions, provide long term ventilation, support and/or manage
tracheal/bronchial secretions. Recall # Z-1491-2010;
31) Shiley Cuffed Pediatric Tracheostomy Tube, 4.0 PDC, Assembled in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall Z-1492-2010;
32) Shiley Cuffed Pediatric Tracheostomy Tube, 4.5 PDC, Assembled in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1493-2010;
33) Shiley Cuffed Pediatric Tracheostomy Tube, 5.0 PDC, Assembled in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1494-2010;
34) Shiley Cuffed Pediatric Tracheostomy Tube, 5.5 PDC, Assembled in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1495-2010;
35) Shiley Cuffed Long Pediatric Tracheostomy Tube, 5.0 PLC, Assembled
in Mexico. Intended for bypass of upper airway obstructions, provide
long term ventilation, support and/or manage tracheal/bronchial
secretions. Recall # Z-1496-2010;
36) Shiley Cuffed Long Pediatric Tracheostomy Tube, 5.5 PLC, Assembled
in Mexico. Intended for bypass of upper airway obstructions, provide
long term ventilation, support and/or manage tracheal/bronchial
secretions. Recall # Z-1497-2010;
37) Shiley Cuffed Long Pediatric Tracheostomy Tube, 6.0 PLC, Assembled
in Mexico. Intended for bypass of upper airway obstructions, provide
long term ventilation, support and/or manage tracheal/bronchial
secretions. Recall # Z-1498-2010;
38) Shiley Cuffed Long Pediatric Tracheostomy Tube, 6.5 PLC, Assembled
in Mexico. Intended for bypass of upper airway obstructions, provide
long term ventilation, support and/or manage tracheal/bronchial
secretions. Recall # Z-1499-2010;
39) Shiley Specialized Tracheostomy Tube, MSCT, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1500-2010;
40) Shiley Specialized Tracheostomy Tube, M5SCT, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1501-2010;
41) Shiley Specialized Tracheostomy Tube, M5.5SCT, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1502-2010;
42) Shiley Specialized Tracheostomy Tube, M6SCT, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1503-2010;
43) Shiley Specialized Tracheostomy Tube, M6.5SCT, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1504-2010;
44) Shiley Specialized Tracheostomy Tube, M7SCT, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1505-2010;
45) Shiley Specialized Tracheostomy Tube, M7.5SCT, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1506-2010;
46) Shiley Specialized Tracheostomy Tube, M8SCT, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1507-2010;
47) Shiley Specialized Tracheostomy Tube, M9SCT, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1508-2010;
48) Shiley Specialized Tracheostomy Tube, M10SCT, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1509-2010;
49) Shiley Specialized Tracheostomy Tube, MPDC, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1510-2010;
50) Shiley Specialized Tracheostomy Tube, M4.0PDC, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1511-2010;
51) Shiley Specialized Tracheostomy Tube, M5.5PDC, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1512-2010;
52) Shiley Specialized Tracheostomy Tube, MPLC, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1513-2010;
53) Shiley Specialized Tracheostomy Tube, M5.5PLC, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1514-2010;
54) Shiley Specialized Tracheostomy Tube, MFEN, Sterile EO, Made in
Mexic. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1515-2010;
55) Shiley Specialized Tracheostomy Tube, M6FEN, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1516-2010;
56) Shiley Specialized Tracheostomy Tube, M8FEN, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1517-2010;
57) Shiley Specialized Tracheostomy Tube, MLPC, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1518-2010;
58) Shiley Specialized Tracheostomy Tube, M6LPC, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1519-2010;
59) Shiley Specialized Tracheostomy Tube, M8LPC, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1520-2010;
60) Shiley Specialized Tracheostomy Tube, MDCT, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1521-2010;
61) Shiley Specialized Tracheostomy Tube, M6DCT, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1522-2010;
62) Shiley Specialized Tracheostomy Tube, M8DCT, Sterile EO, Made in
Mexico. Intended for bypass of upper airway obstructions, provide long
term ventilation, support and/or manage tracheal/bronchial secretions.
Recall # Z-1523-2010
through 0911000221;
MANUFACTURER: Recalling Firm: Nellcor Puritan Bennett Inc. (dba Covidien
Ltd), Boulder, CO, by letter dated April 13, 2010.Manufacturer: MMJ S.A
de C.V., Juarez, Mexico. Firm initiated recall is ongoing.
REASON: Inflatable cuff Tracheostomy tubes may leak air, resulting in
inadequate ventilation.
PRODUCT
1) GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor. Recall #
Z-1526-2010;2) GE, 1009-9002-000 Avance Anesthesia Machine and Monitor.
Recall # Z-1527-2010
MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by
letter dated March 12, 2010.Manufacturer: Datex - Ohmeda, Inc., Madison,
WI. Firm initiated recall is ongoing.
REASON: Unanticipated shut-down: A specific lot of GE Healthcare Aisys
and Avance machines control board wiring harness have a defect, which
can cause the machine to unexpectedly shut down, terminating
ventilation, anesthetic delivery, and potentially patient monitoring.
CLASS II
PRODUCT :
Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with
software versions 3.0.x.x and higher. The RTVue is an optical coherence
tomography system indicated for the in vivo imaging and measurement of
the retina, retinal nerve fiber layer, optic disk, and for cornea and
anterior eye scans as an aid in the diagnosis and management of retinal
disease. Recall # Z-1131-2010
MANUFACTURER: Optovue Inc., Fremont, CA, by letter on January 8, 2010.
Firm initiated recall is ongoing.
REASON: Marketed without proper 510(k) -- No 510(k) clearance for
Optovue RTVue Model-RT100 with Software Versions 3.0.x.x and higher
which includes the Normative Database.
PRODUCT :
Leksell GammaPlan. Leksell GammaPlan is designed for use with the
Leksell Gamma Knife. The Leksell GammaPlan is intended to be used for
planning the dosimetry of treatments in stereotactic radiosurgery and
stereotactic radiation therapy. It processes the inputs of the health
care professional (Neurosurgeons, Radiation Therapists and Radiation
Physicists) such that the desired radiation dose is provided by the
Leksell Gamma Knife to a precisely defined target area within the
cranium. Recall # Z-1134-2010
MANUFACTURER: Recalling Firm: Elekta, Inc., Norcross, GA, by letter
dated November 21, 2008 and January 28, 2009.Manufacturer: Elekta
Instrument AB, Stockholm, Sweden. Firm initiated recall is ongoing.
REASON: Although the co-registration looks good during the verification
step in the co-registration dialog, the obtain transformation may
include an error that depends on the voxel sizes and acquisition
parameters of the co-registered image studies.
PRODUCT :
1) Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01) The Xact Carotid
Stent System, used in conjunction with Emboshield Embolic Protection
System is indicated for the improvement of the lumen diameter of carotid
arteries in patients considered at high risk for adverse events from
carotid endarterectomy who require percutaneous carotid angioplasty and
stenting for occlusive artery disease. Recall # Z-1152-2010;
2) Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01) The Xact Carotid
Stent System, used in conjunction with Emboshield Embolic Protection
System is indicated for the improvement of the lumen diameter of carotid
arteries in patients considered at high risk for adverse events from
carotid endarterectomy who require percutaneous carotid angioplasty and
stenting for occlusive artery disease. Recall # Z-1153-2010
MANUFACTURER: Abbott Vascular-Cardiac Therapies dba Guidant Corp.,
Temecula, CA, by telephone and visit beginning March 19, 2009. Firm
initiated recall is complete.
REASON: The product was distributed prior to approval of a PMA
supplement for a manufacturing line move between sites. There are no
product quality issues associated with this action.
PRODUCT :
CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation
System, Model Number M00480050. The Chilli Cooled Ablation System is
indicated for cardiac electrophysiological mapping, delivering
diagnostic pacing stimuli and radiofrequency ablation of mappable
ventricular tachycardias attributable to ischemic heart disease or
cardiomyopathy in patients who have failed drug therapy. Recall #
Z-1156-2010
MANUFACTURER: Recalling Firm: Boston Scientific Corp., San Jose, CA, by
letter on September 22, 2009. Manufacturer: Barnant Co. Barrington, IL.
Firm initiated recall is ongoing.
REASON: Product failure-- Product may cease operation as a result of
potential speed control board failure when the device is shut off, and
may not turn back on. A component on the circuit board fails
unexpectedly because of a power surge, causing a diode to burn out.
PRODUCT :
1) Philips Heartstart FRx automated external defibrillator (AED), Model
861304. Recall # Z-1193-2010;
2) Philips Heartstart (HS1) Onsite Automated External Defibrillator
(AED) Catalog number M5066A. Recall # Z-1194-2010;
3) Heartstart (HS1) Laerdal brand onsite Automated External
Defibrillator, Model M5067A.
Recall # Z-1195-2010;
4) Heartstart HS1 Defibrillator Model M5068A. Recall # Z-1196-2010
MANUFACTURER: Philips Medical Systems, Seattle, WA, by telephone and
e-mail on November 2, 2009 and by letters on November 9, 2009. Firm
initiated recall is ongoing.
REASON: Potential for failure of a capacitor during use which would
prevent the AED from delivering effective defibrillation therapy when
indicated.
PRODUCT :
Shutter HX SP5, a component of the Leica Point Scanning Confocal
Microscope Models TCS SP5 and TCS SP5 X. Material No: 1531160006 Spare
Part No: 15000904000093; Laboratory instrument. Recall # Z-1221-2010
MANUFACTURER: Recalling Firm: Leica Microsystems, Inc., Bannockburn, IL,
by letter on November 12, 2009. Manufacturer: Leica Microsystems GmbH,
Mannheim, Germany. Firm initiated recall is complete.
REASON: A manufacturing defect was identified that could potentially
result in the laser shutter not closing as intended which could result
in the shutter not completely closing disrupting the laser beam safely.
PRODUCT :
Vertier Surgical Table, Catalog numbers 0788100000, 0788100000S,
0788100001, and 0788100001S. Recall # Z-1238-2010
MANUFACTURER: Stryker Communications Corp., Flower Mound, TX, by letter
on November 13, 2009.Manufacturer: Merivaara Corp., Lahti, Finland. Firm
initiated recall is ongoing.
REASON: In certain positions, product is susceptible to fluid intrusions
which could possibly result in short circuit or unsolicited movement.
PRODUCT :
Biomet Microfixation, Patient Distractor Driver 10.87cm, (4.28")(L),
Radel, Stainless Steel, Non-Sterile Product. Part Number SP-1918. Recall
# Z-1319-2010
MANUFACTURER: Biomet Microfixation, Inc., Jacksonville, FL, by letter,
fax or e-mail on May 15, 2010. Firm initiated recall is ongoing.
REASON: The patient Distractor Driver, used in Osteotomy procedures, may
not ratchet and advance the distraction device as intended. If the
distraction device does not advance, bone consolidation may occur and a
second surgery may be necessary.
PRODUCT :
Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm
Countersink, Model # HCS-070-38. Used to drill or cut bone prior to
implantation of screws. Recall # Z-1430-2010
MANUFACTURER: Recalling Firm: Orthohelix Surgical Designs Inc., Medina,
OH, by letters on September 3, 2009. Manufacturer: NG Instruments, Inc.,
Warsaw, IN. Firm initiated recall is ongoing.
REASON: The epoxy is flaking off the drill bits and countersinks.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
May 05, 2010
CLASS II
PRODUCT:
1) Orthofix US XCaliber Meta-Diaphyseal Complete Kit, Sterile. 99-91600.
Intended for use in the treatment of bone conditions including leg
lengthening, osteotomies, arthrodesis, fracture fixation and other bone
conditions amenable to treatment by use of the external fixation
modality. Recall # Z-1434-2010;
2) Orthofix US XCaliber Ankle Complete Kit, Sterile, 99-91647. Intended
for use in the treatment of bone conditions including leg lengthening,
osteotomies, arthrodesis, fracture fixation and other bone conditions
amenable to treatment by use of the external fixation modality. Recall #
Z-1435-2010
MANUFACTURER: Orthofix Srl, Bussolengo (Verona), Italy, by Field Safety
Notice, dated February 22, 2010. Firm initiated recall is completed.
REASON: During standard quality controls, firm identified a potential
for breakage of the XCaliber clamp when locking the cam
PRODUCT:
Elekta Synergy Intended to be used for radiation therapy treatment of
malignant neoplastic diseases. Recall # Z-1441-2010
MANUFACTURER: Recalling Firm: Elekta, Inc., Norcros, GA, by letters on
March 13, 2008 and October 17, 2008.Manufacturer: Elekta Oncology
Systems (Fmrl Philipps), Crawley, West Sussex, United Kingdom. Firm
initiated recall is ongoing.
REASON: Installation of a touchguard to prevent injury to patients or
staff by stopping machine movements in the case of accidental collision.
PRODUCT:
Literature for Implant Extraction Set - Implant Extraction Guide Module
One & Two. Lists and describes the instruments which are in the Implant
Extraction Set and the general application of these instruments for
hardware removal. Recall # Z-1443-2010
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah,
NJ, by letters on March 2, 2010.Manufacturer: Stryker Trauma GmbH,
Schonkirchen, Germany. Firm initiated recall is ongoing.
REASON: Literature did not include the design change to a smaller
cannulation diameter.
PRODUCT:
Baxter RenAmin (Amino Acid) Injection; Pharmacy Bulk Package Not for
Direct Infusion, Rx Only, 250 mL type II glass bottles; Made in USA;
product code 2A6222. Recall # Z-1528-2010;2) Baxter Evacuated Container,
250 mL, Sterile, non pyrogenic, Rx Only. Made in USA, product code
1A8502. Recall # Z-1529-2010;3) Baxter Evacuated Container, 500 mL,
Sterile, non pyrogenic, Rx Only. Made in USA, product code 1A8503.
Recall # Z-1530-2010
MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL,
by letters dated February 15, 2010. Manufacturer: Baxter Healthcare
Corp., Cleveland, MS. Firm initiated recall is ongoing.
REASON: Routine stability testing of the evacuated container product,
along with trending of results, indicates that the pH will exceed the
upper specification limit prior to the expiration date of this product.
PRODUCT:
Medtronic HMS PLUS, Hemostasis Management System. A microprocessor
based, multichannel clot timing instrument with automated syringe
handling for pipetting blood into single use cartridges. It performs in
vitro heparin sensitivity evaluations, heparin assays, activated
clotting times and platelet function evaluations. HMS Plus Catalog
Number: 30514. Recall # Z-1537-2010
MANUFACTURE: Recalling Firm: Medtronic Inc. Cardiac Rhythm Disease
Management, Saint Paul, MN, by letter dated March 8, 2010. Manufacturer:
Medtronic Cardiovascular Revascularization & Surgical TherapBrooklyn
Park, MN; Medtronic Blood Management, Parker, CO. Firm initiated
recallis ongoing.
REASON: The heparin assay controls may run longer than normal and in
some cases; fail to give an acceptable result.
PRODUCT:
Leksell Gamma Knife C. Recall # Z-1533-2010
MANUFACTURER: Recalling Firm: Elekta, Inc., Norcross, GA, by Technical
Note – dated July 2006 and Aug. 28, 2006.Manufacturer: Elekta Instrument
AB, Stockholm, Sweden. Firm initiated recall is complete.
REASON: Leksell Gamma Knife C 1.2 with MCU version 4.0.0.6 improperly
adjusted trolley for 4mm helmet caused jamming when helmet changer
attempted to lock helmet. Lock did not fully engage and could still be
raised. When the lock does not engage, then when the helmet changer
rises, the helmet could disengage from the helmet changer and fall back
onto the helmet trolley.
PRODUCT:
Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis
Valve/Side Port for use with 7.5 - 8 Fr. Catheters. Permits venous
access and catheter introduction to the central circulation. Catalog
number: ASK-09903-CMC. Recall # Z-1538-2010
MANUFACTURER: Recalling Firm: Arrow International Inc., Reading, PA, by
letter on/about December 15, 2009.Manufacturer: Arrow International
Inc., Asheboro, NC. Firm initiated recall is ongoing.
REASON: Some central venous catheter sets had the incorrect lid stock.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
April 28, 2010
CLASS II
PRODUCT:
NicoletOne vEEG System. Recall # Z-1256-2010
MANUFACTURER: CareFusion, Middleton, WI, by letter dated March 3, 2010.
Firm initiated recall is ongoing.
REASON:..CareFusion NeuroCare is voluntarily implementing a field
correction to delete certain NicoletOne software protocols, which users
may interpret incorrectly when conducting patient evaluations. The field
correction involves providing users with instructions for removing the
subject protocols and verifying the deletion has been properly
conducted. CareFusion NeuroCare believes that the products in the field
with the original configuration are not likely to cause any adverse
events for patients.
PRODUCT
Renessa RF System, model PR0918. Recall # Z-1404-2010
MANUFACTURER: Novasys Medical Inc., Newark, CA, by letter
August/September of 2009. Firm initiated recall is ongoing.
REASON: IFU revision-- Because of complaints received by the firm, the
instructions for use were revised to emphasize potential side effects
PRODUCT
Varian Medical Systems, Eclipse Treatment Planning System, with v client
versions 7.3 (build 7.3.10), 8.0 (builds 7.5.x), 8.1 (builds 8.1.x) and
8.5( builds 8.2.x). For radiation therapy. Recall # Z-1412-2010
MANUFACTURER: Varian Medical Systems Oncology Systems, Palo Alto, CA, by
letter on December 9, 2009. Firm initiated recall is ongoing.
REASON: Potential for misdelivery of treatment-- When preparing a
treatment plan involving a split, the device may calculate excessive or
insufficient monitor units for the treatment plan.
PRODUCT
1) 3M Micropore Single Use Rolls, Surgical Tape, REF 1530S-1, 1 in x
1-1/2 yd. Recall # Z-1413-2010;
2) 3M Micropore Paper Tape, Cat. No. 1530-118, 1 in x 18 in., 800 rolls
/ case. Recall # Z-1414-2010;
3) 3M Micropore Paper Tape, Cat. No. 1530-136, 1 in x 36 in., 800 rolls
/ case. Recall # Z-1415-2010;
4) 3M Micropore Paper Tape, Cat. No. 1530-154, 1 in x 54 in., 800 rolls
/ case. Recall # Z-1416-2010;
5) 3M Micropore Paper Tape, Cat. No. 1530-12Y, 1 in x 2YDS., 630 rolls /
case. Recall # Z-1417-2010;
6) 3M Micropore Paper Tape, Cat. No. 1530-15Y, 1 in x 5YDS., 441 rolls /
case. Recall # Z-1418-2010;
7) 3M Micropore Paper Tape, Cat. No. 1530-254, 2 in x 54 in., 400 rolls
/ case. Recall # Z-1419-2010;
8) 3M Micropore Paper Tape, Cat. No. 1530-336, 3 in x 36 in., 240 rolls
/ case. Recall # Z-1420-2010
MANUFACTURER: Recalling Firm: 3M Company / Medical Division, Saint Paul,
MN, by letter beginning January 29, 2010 and letter dated February 22,
2010.
Manufacturer: 3M Drug Delivery Systems, Brookings, SD. Firm initiated
recall is ongoing.
REASON: Reduced adhesion: Micropore Surgical Tape for use as the primary
securement device for 1) dialysis needles used to access A-V fistulas or
grafts; or 2) pressure dressings used after dialysis treatments. If the
tape does not perform, the dialysis needle may loosen and could then
dislodge. In the interim, please offer 3M Micropore Surgical Tape, 1
inch x 10 yard rolls (CAT #1530-1) as a substitution until supply of
single-use rolls is available.P
PRODUCT
Cordis, AVANTI+ Introducer, Sterile EO, For one use only. Catalog #
402656X; Catalog #504606X; Catalog #504656X. Recall # Z-1421-2010
MANUFACTURER: Recalling Firm: Cordis Corp., Miami Lakes, FL, by letter
on January 28, 2010. Manufacturer: Cordis de Mexico, S.A. de C.V., Cd.
Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON: Sterility compromised: Cordis found a pin hole in one of the
packaging tray cavities. During routine inspection, a visual
irregularity was detected in packing trays.
PRODUCT
Integra, Licox Ref 1P2.P; Brain PMO-Probe Kit Rx only; Contains
Products: REF 1P2 Bolt kit for 2 Brain probes, REF CC1/P1 Combined
Oxygen & Temperature Probe. Contents Sterile and Non-Pyrogenic if
package is unopened and undamaged. Catalog number CC1P1. Recall #
Z-1422-2010
MANUFACTURER: Recalling Firm: Integra LifeSciences Corp., Plainsboro,
NJ, by letter on February 18, 2010.Manufacturer: Gesellschaft Fur
Medizinische GMS, MBH, Mielkendorf, Germany. Firm initiated recall is
complete.
REASON: One probe that had failed a product release test was
inadvertently packaged and released into inventory in Integra's
distribution center.
PRODUCT
Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192,
ANS. Product is intended to be used as an accessory to the leads
component of ANS SCS systems, functioning to secure the lead to the
fascia or interspinous/supraspinous ligament. Recall # Z-1425-2010
MANUFACTURER: Advanced Neuromodulation Systems, Inc., Plano, TX,
verbally on February 22, 2010 and by letter dated March 8, 2010. Firm
initiated recall is ongoing.
REASON: Directions for use of product incorrectly stated lead
compatibility information.
PRODUCT
REF 822 IMUBIND(R) Plasma PAI-1 ELISA The intended use: Product is an
enzyme-linked immunosorbent assay for the quantative measurement of
human Plasminogen Activator Inhibitor Type-1 (PA-1) antigen in plasma.
Recall # Z-1426-2010
MANUFACTURER: American Diagnostica, Inc., Stamford, CT, by emails dated
March 1, 2010. Firm initiated recall is ongoing.
REASON: Unacceptable microwell to microwell variation in the section of
the plate that is typically used for the calibrators.
PRODUCT
iView GT Electronic Portal Imaging Device, used with radiation therapy
treatments. Recall # Z-1436-2010
MANUFACTURER: Recalling Firm: Elekta, Inc., Norcross, GA, by letter on
July 31, 2009.Manufacturer: Elekta Oncology Systems (Fmrl Philipps),
Crawley, West Sussex, United Kingdom. Firm initiated recall is ongoing.
REASON: Image problems that have an effect on patient position
corrections and on the accuracy of the radiation treatment.
CLASS III
PRODUCT
Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac,
60Hz/2.5A IEC 60601-1 Class I, Type BF. Product number: 8510-0001-00 Rev
1. Recall # Z-1437-2010
MANUFACTURER: Recalling Firm: Diopsys, Inc., Pine Brook, NJ, by e-mail
on April 2, 2007.Manufacturer: Nexcore Technology, Inc., Waldwick, NJ.
Firm initiated recall is complete.
REASON: The computer based system may lose test counts when the time in
the device was changed during a changeover from standard time to
daylight savings time in March 2007.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
April 21, 2010
CLASS II
PRODUCT
1) Pelton & Crane Dental Chairs, Chairman 5000 with magnetic headrest.
Intended for the properly positioning of patients to perform dental
procedures. Recall # Z-1179-2010;
2) Pelton & Crane Dental Chairs, Spirit 1500 with magnetic headrest.
Intended for the properly positioning of patients to perform dental
procedures. Recall # Z-1180-2010;
3) Pelton & Crane Dental Chairs, Spirit 1800 with magnetic headrest.
Intended for the properly positioning of patients to perform dental
procedures. Recall # Z-1324-2010;
4) Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest.
Intended for the properly positioning of patients to perform dental
procedures. Recall # Z-1325-2010;
5) Pelton & Crane Dental Chairs, Spirit 3000 with magnetic headrest.
Intended for the properly positioning of patients to perform dental
procedures. Recall # Z-1326-2010
MANUFACTURER: Pelton & Crane Company, Charlotte, NC, by letter dated
February 24, 2010. Firm initiated recall is ongoing.
REASON: Magnetic headrests may affect patients with implantable
pacemakers and defibrillators.
PRODUCT
Howmedica Restoration ADM Trial Cup Holder; Non Sterile; The intended
use: The Restoration ADM Window Trial is locked onto the Restoration ADM
Trial Cup Holder and placed into the acetabulum to evaluate the size and
congruity of the preparation for visualization and assessment of fit,
contact and congruency of the trial within the acetabulum. Catalog
number: 1235-0-000. Recall # Z-1201-2010
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah,
NJ, by letter dated January 21, 2010.Manufacturer: Stryker, Saint Clair,
Cedex, France. Firm initiated recall is ongoing.
REASON: The Restoration ADM Trial Cup Holder may not have been assembled
correctly.
PRODUCT
Leksell Gamma Knife Perfexion, Product Number: 715000. Intended for
stereotactic irradiation of head structures ranging from very small
target sizes of a few millimeters to several centimeters. Recall #
Z-1232-2010
MANUFACTURER: Recalling Firm: Elekta, Inc., Norcross , GA, by letter
dated November 6, 2009. Manufacturer: Elekta Instrument AB, Stockholm,
Sweden. Firm initiated recall is ongoing.
REASON: There may be a situation where the Frame Adapter might lock the
stereotactic Frame in the wrong position.
PRODUCT
Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device
indicated for use in the stereotactic irradiation of intracranial
structures. Recall # Z-1236-2010
MANUFACTURER: Recalling Firm: Elekta, Inc., Norcross, GA, by Field
Change Order, October 1, 2007.Manufacturer: Elekta Instrument AB,
Stockholm, Sweden. Firm initiated recall is ongoing.
REASON: After updating the LGK actuator in spare part 810361, the old
sleigh became obsolete due to causing insufficient locking of the helmet
in combination with the new actuator.
PRODUCT
Agendia MammaPrint, Catalog Numbers MP01, MP US version 03. Recall #
Z-1321-2010
MANUFACTURER: Agendia Inc., Huntington Beach, CA, by visit on March 3,
2010. Firm initiated recall is ongoing.
REASON: Over a period of about 6 months in about 15% of results provided
Agendia has been "over reporting" the chance of metastasis risk being
29% risk of recurrence instead of 10% risk. This over reporting of risk
did not cause direct injury to patients. However, if used by physicians
as the sole basis for decision-making, affected patients may have
received unnecessary therapy.
PRODUCT
Baxter 1550 Single Patient System Hemodialysis Machines; product codes
5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R. Recall # Z-1322-2010
MANUFACTURER: Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw Park,
IL, by letter dated January 29, 2010. Manufacturer: Baxter Healthcare
Corp., Largo, FL. Firm initiated recall is ongoing.
REASON: Some of the 1550 Hemodialysis Instruments may have replacement
circuit boards with incorrect versions of software.
PRODUCT
The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID
tubing), Sterile, Single use only --- 510 (k) 981284 The intended use:
Bigger Better-Bladder serves as an inline reservoir providing compliance
and allowing noninvasive pressure measurements. It is a length of
standard perfusion tubing with a thin walled, elongated balloon sealed
with a rigid housing. Recall # Z-1323-2010
MANUFACTURER: Recalling Firm: Circulatory Technology Inc., Oyster Bay,
NY, by emails and telephone on June 3, 2009 and on June 13, 2009.
Manufacturer: Metrix Co, Dubuque,IA. Firm initiated recall is complete.
REASON: During an FDA inspection, it was discovered that the firm had
conducted a silent recall of its Bigger Better Bladder device after
receiving a complaint from a hospital that the device collapsed during a
procedure thereby obstructing flow.
PRODUCT
1) GE Centricity PACS-IW software; The intended use: The Centricity
PACS-IW is used to receive medical images (including mammograms) and
data from various imaging sources. Images and data can be stored,
communicated, processed and displayed within the system or across
computer networks at distributed locations. Recall # Z-1394-2010;
2) GE Centricity Web Diagnostic 1.0 (WebDX) software; The Intended use:
The Centricity PACS-IW is used to receive medical images (including
mammograms) and data from various imaging sources. Images and data can
be stored, communicated, processed and displayed within the system or
across computer networks at distributed locations. Recall # Z-1395-2010
MANUFACTURER: Recalling Firm: Ge Healthcare It, Barrington, IL, by
letters dated February 18, 2010. Manufacturer: Dynamic Imaging, LLC,
Allendale, NJ. Firm initiated recall is ongoing.
REASON: There is a potential safety issue associated with the use of GE
Centricity PACS-IW and PACS Web Diagnostic software related to use of
built-in reconstruction functions which may result in incorrect anatomic
orientation markers.
PRODUCT
SmarTemp Probe Covers with the Accutorr V Monitor; Rx only. Packaged in
boxes of 20, Model ST010, also distributed in boxes of 2000 (10
individual boxes of 200); SmarTemp Module Kit (contains one box of 20
probes) and SmarTemp Temperature Probe Kits (contains one box of 20
probes). Probe Cover for use with the SmarTemp Reusable Temperature
Probe. The following product numbers: 1) M09A-20-62124 Covers, Temp
Probe- box of 20 probes and M09A-30-62128 Covers, Temp Probe - box of
2000 (10 boxes of 200); 2).A box of 20 Disposable Probe Covers (part
number M09A-20-62124) are also included in the following kits:
0020-00-0192 - SmarTemp Module Kit and 6006-30-39590 - SmarTemp
Temperature Probe Kit. Recall # Z-1396-2010;
2) SmarTemp Probe Covers for use with the DPM3 Monitor; Rx only, Mindray
DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010 also
distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp
Module Kit (contains one box of 20 probes) and SmarTemp Temperature
Probe Kits (contains one box of 20 probes). Probe Cover for use with the
SmarTemp Reusable Temperature Probe. 1) M09A-20-62124 Covers, Temp
Probe- box of 20 probes and M09A-30-62128 Covers, Temp Probe - box of
2000 (10 boxes of 200); 2) A box of 20 Disposable Probe Covers (part
number M09A-20-62124) are also included in the following kits:
0020-00-0192 - SmarTemp Module Kit and 6006-30-39590 - SmarTemp
Temperature Probe Kit. Recall # Z-1397-2010;
3) SmarTemp Probe Covers for use with the VS-800 Monitor; Rx only,
Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model
ST010, also distributed in boxes of 2000 (10 individual boxes of 200);
SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp
Temperature Probe Kits (contains one box of 20 probes). Probe Cover for
use with the SmarTemp Reusable Temperature Probe. 1) M09A-20-62124
Covers, Temp Probe- box of 20 probes and M09A-30-62128 Covers, Temp
Probe - box of 2000 (10 boxes of 200); 2) A box of 20 Disposable Probe
Covers (part number M09A-20-62124) are also included in the following
kits: 0020-00-0192 - SmarTemp Module Kit and 6006-30-39590 - SmarTemp
Temperature Probe Kit. Recall # Z-1398-2010.
MANUFACTURER: Recalling Firm: Mindray DS USA, Inc., dba Datascope
Patient Monitoring, Mahwah, NJ, by letter dated December 31, 2009.
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.,
Nanshan, Shenzhen, China. Firm initiated recall is ongoing.
REASON: SmarTemp Disposable Probe covers may contain microscopic holes
in the molded seam that would allow liquids or body fluids inside the
cover and potentially contaminate the temperature probe.
PRODUCT
Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque
Quick, Qty 1 Non Sterile Mat: 17-4PH. The intended use: Used to
stabilize and aid in the fixation of fractures, fusions, and osteotomies.
Recall # Z-1399-2010
MANUFACTURER: Recalling Firm: Orthohelix Surgical Designs Inc, Medina,
OH, by letters, dated October 16, 2009, and November 19,
2009.Manufacturer: Gauthier Biomedical Inc., Grafton, WI. Firm initiated
recall is ongoing.
REASON: The adapters are able to come apart when a retaining ring in the
proximal end of the adapter can dislodge from the retaining ring groove
and the two ends of the adapter fall apart and are unable to be
reassembled without special tools and knowledge of the instrument. Also
the adapters have a wobble between the two ends. This is caused when the
distal and proximal ends of the adapter assembly were welded
non-concentric to one another.
PRODUCT
Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4. Recall #
Z-1409-2010
MANUFACTURER: Boston Scientific Neuromodulation Corp., Valencia, CA, by
letter dated March 19, 2010. Firm initiated recall is ongoing.
REASON: Toshiba has determined that certain Sony battery packs installed
in Toshiba portable computers can overheat, posing fire hazard to
customers. Based on Toshiba's investigation with Sony Corporation, they
concluded that the battery cells in specific manufacturing lots could be
affected.
PRODUCT
Syngo Imaging XS model number 10496279. The intended use: image
processing radiological. Recall # Z-1423-2010
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Malvern, PA, by letter dated February 16, 2010.Manufacturer: Siemens
Medical Solutions Inc., Erlangen, Germany. Firm initiated recall is
ongoing.
REASON: Images can be overwritten.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
April 14, 2010
CLASS I
PRODUCT
1) Powerheart 9300A automated external defibrillator. This fully
automatic model does not require the user to press a shock button in
order for the device to deliver therapy (when appropriate). Brand name:
Cardiac Science. Product name: Powerheart. Device Operation: Fully
automatic. Color: Yellow. Voice Prompt Level: Basic. CPR Metronome: No.
Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No. Recall
# Z-1243-2010;
2) Powerheart 9300E automated external defibrillator. This
semi-automatic model requires the user to press a shock button in order
for the device to deliver defibrillation energy (when appropriate).
Brand name: Cardiac Science. Product name: Powerheart. Device Operation:
Semi-automatic. Color: Yellow. Voice Prompt Level: Basic. CPR Metronome:
No. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.
Recall # Z-1244-2010;
3) Powerheart 9300P automated external defibrillator. This
semi-automatic model requires the user to press a shock button in order
for the device to deliver defibrillation energy (when appropriate).
Brand name: Cardiac Science. Product name: Powerheart. Device Operation:
Semi-automatic w/manual override. Color: Yellow. Voice Prompt Level:
Basic. CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display:
Yes. ECG Display: Yes. Recall # Z-1245-2010;
4) Powerheart 9390A automated external defibrillator. This fully
automatic model does not require the user to press a shock button in
order for the device to deliver therapy (when appropriate). Brand name:
Cardiac Science. Product name: Powerheart. Device Operation: Fully
automatic. Color: Yellow. Voice Prompt Level: Extensive.(Extensive voice
prompts provide more detailed instruction on device use, pad placement
and CPR performance, as compared to the basic prompts.) CPR Metronome:
Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.
Recall # Z-1246-2010;
5) Powerheart 9390E automated external defibrillator. This
semi-automatic model requires the user to press a shock button in order
for the device to deliver defibrillation energy (when appropriate).
Brand name: Cardiac Science. Product name: Powerheart. Device Operation:
Semi-automatic. Color: Yellow. Voice Prompt Level: Extensive.(Extensive
voice prompts provide more detailed instruction on device use, pad
placement and CPR performance, as compared to the basic prompts.) CPR
Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG
Display: No. Recall # Z-1247-2010;
6) Responder 2023440 automated external defibrillator. This
semi-automatic model requires the user to press a shock button in order
for the device to deliver defibrillation energy (when appropriate).
Brand name: GE. Product name: Responder. Device Operation:
Semi-automatic w/manual override. Color: GE Gold. Voice Prompt Level:
Basic. CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display:
Yes. ECG Display: Yes. Recall # Z-1248-2010;
7) Cardiovive 92532 automated external defibrillator. This
semi-automatic model requires the user to press a shock button in order
for the device to deliver defibrillation energy (when appropriate).
Brand name: Burdick. Product name: Cardiovive. Device Operation:
Semi-automatic. Color: Blue. Voice Prompt Level: Basic. CPR Metronome:
No. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No.
Recall # Z-1249-2010
MANUFACTURER: Recalling Firm: Cardiac Science Corp., Bothell, WA, by
letters on February 3, 2010Manufacturer: Cardiac Science Corp.,
Deerfield, WI. Firm initiated recall is ongoing.
REASON: component of the AED device may fail during a rescue attempt and
the AED will not be able to deliver therapy
CLASS II
PRODUCT
1) DigitalDiagnost General radiographic examinations and applications
wherever a solid state X-ray imaging device can be used. Recall #
Z-0847-2010;
2) BuckyDiagnost General Radiography and Tomography examination of
patients in supine, seated, or standing positions. Recall # Z-0848-2010;
3) EasyDiagnost Multi-functional R/F systems used for general R/F,
Fluoroscopy, Radiography and Angiography examinations. Recall #
Z-0849-2010;
MANUFACTURER:Philips Medical Systems North America Co. Phillips,
Bothell, WA, by letters dated January 20 and 21, 2010. Firm initiated
recall is ongoing.
REASON:Device failed to display appropriate labels indicating Radiation
Symbol along with the required wording.
PRODUCT
Cardinal Health EnVe Ventilator Cat # 19250-001. Intended to provide
continuous or intermittent ventilatory support for the care of
individuals who require mechanical ventilation. Recall # Z-0857-2010
MANUFACTURER:CareFusion 203, Inc., Minneapolis, MN, by letter dated
January 7, 2010. Firm initiated recall is ongoing.
REASON:CareFusion is recalling the EnVe Ventilator because the EnVe
Ventilator does not fully meet applicable standards for immunity to
electro-Magnetic Interference (EMI) when tested in the laboratory
environment. CareFusion has identified certain device malfunctions that
may affect device performance and patient safety in the intended use
environment.
PRODUCT
1) Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch,
Needless Y-site, REF 011901NY, Sterile EO, Assembled In Mexico. Safety
IV administration set used to access surgically implanted vascular
ports. Recall # Z-0861-2010;
2) Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, REF
011901, Sterile EO, Assembled In Mexico. Safety IV administration set
used to access surgically implanted vascular ports. Recall # Z-0862-2010
MANUFACTURER:Recalling Firm: Bard Access Systems, Salt Lake City, UT, by
visit beginning January 2010.Manufacturer: Bard Healthcare, Reynosa,
Mexico. Firm initiated recall is ongoing.
REASON:After activation of the safety mechanism, the tip of the needle
protrudes from the safety sheath creating the potential for needlestick
injury.
PRODUCT
CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager
Software. Recall # Z-1252-2010
MANUFACTURER:Picis, Inc., Wakefield, MA, by letter beginning on March 8,
2010. Firm initiated recall is ongoing.
REASON:Under specific timing of conditions and in configuration with 3rd
party infusion pumps, an error within the clinical application causes
the manual documentation of clinical orders to be changed to an
automatic update status
PRODUCT
1) Qwix 4.3mm Stabilization Screws - 32mm. Part Number: 111432SND.
Recall # Z-1253-2010;
2) Qwix 4.3mm Stabilization Screws - 34mm, Part Number: 111434SND.
Recall # Z-1254-2010
MANUFACTURER:Recalling Firm: Integra LifeSciences Corp., Cincinnati, OH,
by telephone or letter on February 12, 2010.
Manufacturer: NewDeal SA, Lyon, France. Firm initiated recall is
ongoing.
REASON: The screws were etched incorrectly as 32mm instead of the
correct 34mm length.
PRODUCT
Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019.
Recall # Z-1255-2010
MANUFACTURER Encore Medical, LP, Austin, TX, by e-mail on February 22,
2010. Firm initiated recall is ongoing.
REASON: One lot of product was incorrectly manufactured. Pegs are larger
than specification.
PRODUCT
Axiom Artis Systems Operating with VB22, VB23, VB30, and VB31. Model
number 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373,
and 7728392. Intended use: Angiographic x-ray system. Recall #
Z-1312-2010
MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by
letter dated February 16, 2010.Manufacturer: Siemens Medical Solutions
Inc., Erlangen, Germany. Firm initiated recall is ongoing
REASON: Communication problems can occur which may result in
unavailability of Bypass Fluoro.
PRODUCT
Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000
Anesthesia Delivery System is a continuous flow inhalation gas
anesthesia system that delivers anesthetic vapor, provides for automatic
and manual modes of ventilation, and is equipped with a monitoring
system for ventilation, inspired and expired gas. The AS3000 is intended
for use in operating rooms. It is used with O2, N2O and AIR supplied by
a medical gas pipeline system or by externally mounted gas cylinders.
Anesthetic agent can be delivered via vaporizers mounted on the machine.
Product numbers 0998-00-3024-01. Recall # Z-1313-2010
MANUFACTURER: Mindray DS USA, Inc., dba Datascope Patient Monitoring,
Mahwah, NJ, by letter dated March 5, 2010. Firm initiated recall is
ongoing.
REASON: An issue affecting the caster mount on the AS3000 System have
been identified, specifically reports of the caster mount breaking,
causing the wheel to fall off and the unit to tip.
END OF ENFORCEMENT REPORT FOR APRIL 14, 2010
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
April 7, 2010
CLASS I
PRODUCT
1) Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with
BD Q-Syte (BD #385151), Part number: 69946B. Recall # Z-1073-2010;
2) Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer
Access Split Septum (BD #385100)), Part number: 69498. Recall #
Z-1074-2010;
3) Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access
Split Septum (BD #385100), Part number: 57977. Recall # Z-1075-2010
MANUFACTURER: Recalling Firm: Medical Action Industries Inc., Arden, NC,
by e-mail, letter on November 6, 2009.
Manufacturer: Becton Dickinson Medical Systems, Sandy, UT. Firm
initiated recall is ongoing.
REASON: Manufacturing defect may allow air entry into a central venous
catheter, possibly resulting in an air embolism.
PRODUCT:
1) Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut
w/BD Q-Syte. Recall # Z-1076-2010;
2) Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut
w/BD Q-Syte. Recall # Z-1077-2010;
3) Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin
Nut w/BD Q-Syte. Recall # Z-1078-2010;
4) Acacia Catalog # 385165 "Y" IV Extension Set 20cm Macro Bore, Spin
Nut w/BD Q-Syte. Recall # Z-1079-2010;
5) Acacia Catalog # 385166 Dual "Y" IV Extension Set 50cm Macro Bore,
Spin Nut w/BD Q-Syte. Recall # Z-1080-2010
MANUFACTURER: Medical Product Specialist Inc dba MPS Acacia, Brea , CA,
by letter dated December 18, 2009. Firm initiated recall is ongoing.
REASON: Some lots of IV Extension Sets with BD Q-Syte Luer Access Split
Septum have a manufacturing deviation which could cause the product to
not function properly, possibly resulting in an air embolism.
PRODUCT
1) IV Sets and Accessories, various configurations. An Intravenous
Administration Tubing set is a device intended for medical purposes that
consists of tubing and components with suitable adaptors used to
transfer blood, plasma or intravascular fluids from a container to a
patient's vascular system. Recall # Z-1112-2010;
2) Y-Type Blood Pump Sets, with Detachable Polysulfone Stopcock. For
Veterinary Use Only and with Two Luer Activated Y-Injection Sites,
Y-Injection Site and 2 Gang 4-Way Polysulfone Stopcocks. An Intravenous
Administration Tubing set is a device intended for medical purposes that
consists of tubing and components with suitable adaptors used to
transfer blood, plasma or intravascular fluids from a container to a
patient's vascular system. Recall # Z-1113-2010;
3) IV Extension Set with Spike and 2-Way Stopcock. An Intravenous
Administration Tubing set is a device intended for medical purposes that
consists of tubing and components with suitable adaptors used to
transfer blood, plasma or intravascular fluids from a container to a
patient's vascular system. Recall # Z-1114-2010;
4) 15 Drop IV Sets, with Retractable Luer-Lock and with Smartsite(TM)
Y-Injection sites and 4-Way Stopcock with Pressure Activated Valve
Manifold. (Approx. 15 drops/ml). An Intravenous Administration Tubing
set is a device intended for medical purposes that consists of tubing
and components with suitable adaptors used to transfer blood, plasma or
intravascular fluids from a container to a patient's vascular system.
Recall # Z-1115-2010;
5) Non-Vented IV Set with 2-Gang "Hi-Flo" Stopcocks with Luer Activated
HEP Lock Valves and Luer Activated Y-Injection Sites. (Approx. 10
Drop/ML). An Intravenous Administration Tubing set is a device intended
for medical purposes that consists of tubing and components with
suitable adaptors used to transfer blood, plasma or intravascular fluids
from a container to a patient's vascular system. Recall # Z-1116-2010;
6) Positive Pressure Blood Pump Sets, with Stopcock and Smartsite(TM)
Y-Injection Site and with 3-Gang 4-Way Stopcocks, Y-Injection Site and
T-Connector. An Intravenous Administration Tubing set is a device
intended for medical purposes that consists of tubing and components
with suitable adaptors used to transfer blood, plasma or intravascular
fluids from a container to a patient's vascular system. Recall #
Z-1117-2010;
7) 60 Drop IV Set with SmartSite(TM) Y-Injection Sites, 2-Gang Standard
Bore Stopcocks and T-Connector. (Approx. 60 Drops/ML) SmartSite(TM) is a
trademark of Alaris Medical Systems, Inc. An Intravenous Administration
Tubing set is a device intended for medical purposes that consists of
tubing and components with suitable adaptors used to transfer blood,
plasma or intravascular fluids from a container to a patient's vascular
system. Recall # Z-1118-2010;
8) 150ML Burette IV Set with SmartSite(TM) Y-Injection Site, 2-Gang
Standard Bore Stopcocks and T-Connector SmartSite(TM) is a trademark of
Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is
a device intended for medical purposes that consists of tubing and
components with suitable adaptors used to transfer blood, plasma or
intravascular fluids from a container to a patient's vascular system.
Recall # Z-1119-2010;
9) 20 Drop IV Set with 3 SmartSite(TM) Y-Injection Sites, 2-Gang 4-Way
Stopcock and Novex Stopcock. (Approx. 20 Drops/ML) SmartSite(TM) is a
trademark of Alaris Medical Systems, Inc. An Intravenous Administration
Tubing set is a device intended for medical purposes that consists of
tubing and components with suitable adaptors used to transfer blood,
plasma or intravascular fluids from a container to a patient's vascular
system. Recall # Z-1120-2010;
10) 8" Microbore Extension with Detachable SmartSite(TM) HEP-Lock and
Retractable Spinning Luerlock. DEHP-Free SmartSite(TM) is a trademark of
Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is
a device intended for medical purposes that consists of tubing and
components with suitable adaptors used to transfer blood, plasma or
intravascular fluids from a container to a patient's vascular system.
Recall # Z-1121-2010;
11) IV Set with Two SmartSite(TM) Y-Injection Sites, Stopcock and 3-Gang
Pressure Activated Manifold Valve and Rotating Luer Lock End SmartSite(TM)
is a trademark of Alaris Medical Systems, Inc. An Intravenous
Administration Tubing set is a device intended for medical purposes that
consists of tubing and components with suitable adaptors used to
transfer blood, plasma or intravascular fluids from a container to a
patient's vascular system. Recall # Z-1122-2010;
12) 8" Extension Set with SmartSite(TM) HEP-Lock and Rotating Luer Lock.
SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An
Intravenous Administration Tubing set is a device intended for medical
purposes that consists of tubing and components with suitable adaptors
used to transfer blood, plasma or intravascular fluids from a container
to a patient's vascular system. Recall # Z-1123-2010;
13) 10 Drop IV Sets, with 3 Pre-Pierced Y-Injection Sites and 3-Gang
Pressure Activated Manifold Valve. (Approx. 10 Drops/ML); with Two
Y-Injection Sites and Rotating Luer Lock (Approx. 10 Drop/ML); with
Positive Pressure Pump with 4-Way "Hi-Flo" Stopcock and 4 Pre-Pierced
"Y" Injection Sites (approx. 10 Drop/mL). An Intravenous Administration
Tubing set is a device intended for medical purposes that consists of
tubing and components with suitable adaptors used to transfer blood,
plasma or intravascular fluids from a container to a patient's vascular
system. Recall # Z-1124-2010;
14) Y-Type Positive Pressure Pump Set with 2-Gang 4-Way Stopcock and
Detachable 4-Way Stopcock. An Intravenous Administration Tubing set is a
device intended for medical purposes that consists of tubing and
components with suitable adaptors used to transfer blood, plasma or
intravascular fluids from a container to a patient's vascular system.
Recall # Z-1125-2010;
15) 7" Non-Kink Extension Set with Rotating Luer-Lock Connector. An
Intravenous Administration Tubing set is a device intended for medical
purposes that consists of tubing and components with suitable adaptors
used to transfer blood, plasma or intravascular fluids from a container
to a patient's vascular system. Recall # Z-1126-2010;
16) Positive Pressure Blood Pumps, with Pre-Pierced Y-Injection Site;
with Three SmartSite(TM)Injection Sites and Rotating Male Luer Lock.
SmartSite(TM) is a trademark of Alaris Medical Systems, Inc; with
2""Hi-Flo" Stopcocks, Twin Y Injection Sites and Detachable 8" Extension
with Retractable Luer-Lock; with Two SmartSite(TM) Y-injection Sites.
SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An
Intravenous Administration Tubing set is a device intended for medical
purposes that consists of tubing and components with suitable adaptors
used to transfer blood, plasma or intravascular fluids from a container
to a patient's vascular system. Recall # Z-1127-2010;
17) Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo"
Stopcock; with Luer Activated Y-Injection Sites, Y-Injection Site and 2
Gang 4-Way Stopcocks; with "Hi-Flo" Stopcocks and SmartSite(TM) Y
Injection Site. SmartSite(TM) is a trademark of Alaris Medical Systems,
Inc.; with Ball Pump 4-Way 3-Gang Stopcock Manifold and 4 SmartSite(TM)
Y-Injection Sites SmartSite(TM) is a trademark of Alaris Medical
Systems, Inc.; with 2 "Hi-Flo" Stopcocks, Two Y Injection Sites and
Detachable 8" Extension with Option Lock; with 2 Vented Spikes and
Double "Hi-Flo" Stopcock. An Intravenous Administration Tubing set is a
device intended for medical purposes that consists of tubing and
components with suitable adaptors used to transfer blood, plasma or
intravascular fluids from a container to a patient's vascular system.
Recall # Z-1128-2010;
18) 4-Way "Hi-Flo" Extension Set with Two SmartSite(TM) Y-Injection
Sites and Rotating Luer Lock SmartSite(TM). An Intravenous
Administration Tubing set is a device intended for medical purposes that
consists of tubing and components with suitable adaptors used to
transfer blood, plasma or intravascular fluids from a container to a
patient's vascular system. Recall # Z-1129-2010;
19) Burette Set with SmartSite(TM) Y-Injection Site and SmartSite(TM)
HEP-Lock on Burette SmartSite(TM) is a trademark of Alaris Medical
Systems, Inc. An Intravenous Administration Tubing set is a device
intended for medical purposes that consists of tubing and components
with suitable adaptors used to transfer blood, plasma or intravascular
fluids from a container to a patient's vascular system. Recall #
Z-1130-2010
MANUFACTURER: Recalling Firm: Arrow International Inc., Reading, PA, by
letter dated February 19, 2010.Manufacturer: Arrow International De
Mexico, S.A.DE C.V., Camargo, Mexico. Firm initiated recall is ongoing.
REASON: Sterility may be compromised.
CLASS II
PRODUCT
da Vinci S Surgical System IS2000 Endoscopic Instrument Control System,
rev. A51_P7. Recall # Z-1161-2010
MANUFACTURER: Intuitive Surgical, Inc., Sunnyvale, CA, by e-mail and
visit on July 1, 2009 and July 7, 2009. Firm initiated recall is
ongoing.
REASON: Gripper or Scissor jaws may close inadvertently, and will not
open on command and various other reported modes of failure. Control by
surgeon may fail and this failure may be difficult to detect.
PRODUCT:
Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and
WA58343L Used in conjunction with a compatible trocar tube, trocar tubes
are used for intraperitoneal access during laparoscopic access during
laparoscopic applications, and enable the passage of endoscopes and
other diagnostic and therapeutic tools through the abdominal wall.
Recall # Z-1163-2010
MANUFACTURER: Recalling Firm: Olympus America Inc., Center Valley, PA,
by letter dated February 8, 2010.Manufacturer: Olympus Winter & Ibe Gmbh
& Co., Hamburg, Germany. Firm initiated recall is ongoing.
REASON: Weak weld seams.
PRODUCT:
UROLOGIX CTC Advance" Standard Microwave Catheter (3.0-5.0 cm), CTC
Advance" Long Microwave Catheter (4.5+ cm), CTC Advance" Short Microwave
Catheter (2.5 -3.5 cm), RTU Plus Balloon, and RTU Plus Handle, Sterile
EO. The CTC Advance" catheters and RTU Plus are used as part of the
Targis System. Each disposable device is packaged on a card inside a
heat sealed pouch. Each Kit Box then hold 3 product pouches: 1 catheter,
1 coolant bag and 1 RTU Plus balloon. The RTU Plus Kit contains 3 RTU
Plus Handles packaged in separate sterile pouches. Recall # Z-1174-2010
MANUFACTURER: Urologix, Inc., Minneapolis, MN, by letter dated February
18, 2010. Firm initiated recall is ongoing.
REASON: The reason for this Recall is a labeling error only; the issue
involves a discrepancy in the "Use Before" date printed on the product
label. In the affected lots, the "Use Before" date, commonly known as
the expiration date, is printed as 2012-12 when it should read 2011-12.
Only the individual product label contains the incorrect date; the Kit
Box label is correct.
PRODUCT:
1) Pelton & Crane Chairman 5000, Spirit 1500, Spirit 1800, Spirit 2000
and Spirit 3000 Dental Chairs with magnetic headrests. Intended for the
properly positioning of patients to perform dental procedures. Chairman
5000-Agency Model #L5, Spirit 1500-Agency Model #SP15, Spirit
1800-Agency Model #SP18, Spirit 2000-Agency Model #SP20 and Spirit
3000-Agency Model #SP30. Recall # Z-1179-2010;
2) Pelton & Crane Chairman 5000, Spirit 1500, Spirit 1800, Spirit 2000
and Spirit 3000 Dental chairs with magnetic headrests. Intended for the
properly positioning of patients to perform dental procedures. Chairman
5000-Agency Model #L5, Spirit 1500-Agency Model #SP15, Spirit
1800-Agency Model #SP18, Spirit 2000-Agency Model #SP20 and Spirit
3000-Agency Model #SP30. Recall # Z-1180-2010
MANUFACTURER: Pelton & Crane Co., Charlotte, NC, by letter dated
February 9, 2010. Firm initiated recall is ongoing.
REASON: Magnetic headrests may affect patients with implantable
pacemakers and defibrillators.
PRODUCT:
Advance Tibial Wedge Augment, REF KTAG-W315, Size 3/2+, Thickness 15
DEG, Surface Non-Porous, 1 Each, 2. The device is intended for use in
total knee arthroplasty for reduction or relief of pain and/or improved
knee function in skeletally mature patients with the following
conditions: 1) Noninflammatory degenerative joint disease, 2)
inflammatory joint disease, 3) correction of functional deformity, 4)
revision procedures where other treatments or devices have failed and 5)
treatment of fractures that are unmanageable using other techniques.
(For cement use only). Recall # Z-1215-2010
MANUFACTURER: Wright Medical Technology, Inc., Arlington, TN, by letter
on February 19, 2010. Firm initiated recall is ongoing.
REASON: The product contained screws with the incorrect length
(incorrectly contained 15 mm length screws instead of the correct 5 mm
length screws).
PRODUCT:
AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with
turn assist & on demand low air loss system. The device is intended to
treat or prevent decubitus ulcers, extensive burns, urinary tract
blockage and to aid circulation. Recall # Z-1216-2010
MANUFACTURER: Recalling Firm: Encompass Therapeutic Support Systems dba
BG North America, Glendale, CA, by letter dated March 5, 2010.
Manufacturer: KAP Medical, Corona, CA. and Leoch Battery Corp, Garden
Grove, CA. Firm initiated recall is ongoing.
REASON: Potential out gasing of the battery and short term ignition of
the gas within the control unit enclosure. This failure mode includes a
risk for fire.
PRODUCT:
Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short
needle, 100 syringes. Used to draw a quantity of pharmaceutical from its
container and allow administration of the pharmaceutical directly to the
patient. As an alternative use the product will allow administration of
the pharmaceutical to the patient via an intravenous port, heparin lock
or saline lock. Recall # Z-1217-2010
MANUFACTURER: Recalling Firm: Ulti Med, Inc., Saint Paul, MN, by letter
dated February 3, 2010.Manufacturer: Shinamerica Inc., De Smet, SD. Firm
initiated recall is ongoing.
REASON: UltiMed, Inc. is recalling one lot of 1cc, 31 gauge x 5/16 inch
U-100 Insulin Syringe Live Better because it is mislabeled and actually
contains 1/2 cc, 30 gauge x 1/2 inch U-100 insulin Syringe.
PRODUCT:
1) Harmony Lux Advantage LA Surgical Lighting and Visualization System,
also known as the Harmony LA 500, B129382391. Designed to provide
visible immunization of the surgical field or the patient and to provide
audio-visual procedural support for the O.R. staff. Intended to be used
in a surgical setting. Recall # Z-1218-2010;
2) Harmony Lux Advantage LA Surgical Lighting and Visualization System,
also known as the Harmony LA 700, B129382393. Designed to provide
visible immunization of the surgical field or the patient and to provide
audio-visual procedural support for the O.R. staff. Intended to be used
in a surgical setting. Recall # Z-1219-2010;
3) Harmony Lux Classic, Surgical Lighting System, also known as the
Harmony LC 500, B129388085 and B12988086. Designed to provide visible
immunization of the surgical field or the patient and to provide
audio-visual procedural support for the O.R. staff. Intended to be used
in a surgical setting. Recall # Z-1220-2010
MANUFACTURER: Recalling Firm: Steris Corp., Mentor, OH, by letter dated
February 23, 2010.Manufacturer: Steris Corp., Montgomery, AL. Firm
initiated recall is ongoing.
REASON: Premature Bulb Failure
PRODUCT:
1) Publix Sterile Preserved Saline Solution 12oz, Product
SKU#041415-003767. This product is supplied in 12 fl. oz. (355 mL)
bottles for use in rinsing of soft (hydrophilic) contact lenses after
heat (thermal) disinfection and rinsing of contact lenses following
chemical disinfection. Recall # Z-1222-2010;
2) Top Care Sterile Preserved Saline Solution 12oz, Product
SKU#0036800-16040. This product is supplied in 12 fl. oz. (355 mL)
bottles for use in rinsing of soft (hydrophilic) contact lenses after
heat (thermal) disinfection and rinsing of contact lenses following
chemical disinfection. Recall # Z-1223-2010;
3) Safeway Sterile Preserved Saline Solution 12oz, Product
SKU#321130-700707. This product is supplied in 12 fl. oz. (355 mL)
bottles for use in rinsing of soft (hydrophilic) contact lenses after
heat (thermal) disinfection and rinsing of contact lenses following
chemical disinfection. Recall # Z-1224-2010;
4) Hannaford Sterile Preserved Saline Solution 12oz, Product
SKU#041268-029297. This product is supplied in 12 fl. oz. (355 mL)
bottles for use in rinsing of soft (hydrophilic) contact lenses after
heat (thermal) disinfection and rinsing of contact lenses following
chemical disinfection. Recall # Z-1225-2010;
5) Kroger Sterile Preserved Saline Solution 12oz, Product
SKU#011110-385956. This product is supplied in 12 fl. oz. (355 mL)
bottles for use in rinsing of soft (hydrophilic) contact lenses after
heat (thermal) disinfection and rinsing of contact lenses following
chemical disinfection. Recall # Z-1226-2010;
6) CVS Sterile Preserved Saline Solution 12oz, Product
SKU#050428-253793. This product is supplied in 12 fl. oz. (355 mL)
bottles for use in rinsing of soft (hydrophilic) contact lenses after
heat (thermal) disinfection and rinsing of contact lenses following
chemical disinfection. Recall # Z-1227-2010
MANUFACTURER: K C Pharmaceuticals, Inc., Pomona, CA, by letter dated
February 17, 2010. Firm initiated recall is ongoing.
REASON: The recall was initiated because the affected lots were
manufactured between two failed media fills; therefore the lots produced
cannot be assured as being free of contamination and may not be sterile.
PRODUCT
CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx
Only. Recall # Z-1235-2010
MANUFACTURER: Smiths Medical ASD, Inc., Saint Paul, MN, by telephone on
December 23, 2009. Firm initiated recall is ongoing.
REASON: The CADD-Legacy 1 Model 6400 Ambulatory Infusion Pump (Serial
Number 370969) was shipped without documentation that the required
accuracy testing had been performed during the manufacturing process. If
the subject infusion pump did not go through the accuracy testing, and
if it does not meet accuracy specifications, there is a potential for
over or under-delivery.
CLASS III
PRODUCT:
PTS Panels CHOL+HDL Panel test strips for professional use with
CardioChek P-A analyzer, Catalog # 1795. The product is used to measure
total cholesterol, and HDL cholesterol, in whole blood. Recall #
Z-0975-2010
MANUFACTURER: Polymer Technology Systems, Inc., Indianapolis, IN, by
letter dated February 20, 2009. Firm initiated recall is complete.
REASON: Extended expiration date; the product expired on February 12,
2009 but was labeled with a April 4, 2009 expiration date.
PRODUCT:
ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter
handpiece, part number 0909-12, Rx, Sterile,. The handpiece is inserted
into the breast to the site of the area of interest. When the proper
location/position is achieved, the handpiece cuts and removes biopsy
tissue. Recall # Z-1160-2010
MANUFACTURER: Hologic, Inc., Indianapolis, IN, by letters dated February
1, 2010. Firm initiated recall is ongoing.
REASON: The product is labeled as ATEC0909-12 but it actually contains
0909-20.
END OF ENFORCEMENT REPORT FOR APRIL 7, 2010
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
March 31, 2010
CLASS I
PRODUCT:
1) Cardiac Science Powerheart 9300A automated external defibrillator.
This fully automatic model does not require the user to press a shock
button in order for the device to deliver therapy (when appropriate).
Intended for use in either in-hospital or out-of-hospital settings for
emergency treatment of victims exhibiting symptoms of sudden cardiac
arrest who are unresponsive and not breathing. Recall # Z-0765-2010; 2)
Cardiac Science Powerheart 9300C automated external defibrillator. This
semi-automatic model requires the user to press a shock button in order
for the device to deliver defibrillation energy (when appropriate).
Intended for use in either in-hospital or out-of-hospital settings for
emergency treatment of victims exhibiting symptoms of sudden cardiac
arrest who are unresponsive and not breathing. Recall # Z-0766-2010; 3)
Cardiac Science Powerheart 9300D automated external defibrillator. This
semi-automatic model requires the user to press a shock button in order
for the device to deliver defibrillation energy (when appropriate).
Intended for use in either in-hospital or out-of-hospital settings for
emergency treatment of victims exhibiting symptoms of sudden cardiac
arrest who are unresponsive and not breathing. Recall # Z-0767-2010; 4)
Cardiac Science Powerheart 9300E automated external defibrillator. This
semi-automatic model requires the user to press a shock button in order
for the device to deliver defibrillation energy (when appropriate).
Intended for use in either in-hospital or out-of-hospital settings for
emergency treatment of victims exhibiting symptoms of sudden cardiac
arrest who are unresponsive and not breathing. Recall # Z-0768-2010; 5)
Cardiac Science Powerheart 9300P automated external defibrillator. This
semi-automatic model requires the user to press a shock button in order
for the device to deliver defibrillation energy (when appropriate).
Intended for use in either in-hospital or out-of-hospital settings for
emergency treatment of victims exhibiting symptoms of sudden cardiac
arrest who are unresponsive and not breathing. Recall # Z-0769-2010; 6)
Cardiac Science Powerheart 9390A automated external defibrillator. This
fully automatic model does not require the user to press a shock button
in order for the device to deliver therapy (when appropriate). Intended
for use in either in-hospital or out-of-hospital settings for emergency
treatment of victims exhibiting symptoms of sudden cardiac arrest who
are unresponsive and not breathing. Recall # Z-0770-2010; 7) Cardiac
Science Powerheart 9390E automated external defibrillator. This
semi-automatic model requires the user to press a shock button in order
for the device to deliver defibrillation energy (when appropriate).
Intended for use in either in-hospital or out-of-hospital settings for
emergency treatment of victims exhibiting symptoms of sudden cardiac
arrest who are unresponsive and not breathing. Recall # Z-0771-2010; 8)
Burdick Cardiovive 92531 automated external defibrillator. This
semi-automatic model requires the user to press a shock button in order
for the device to deliver defibrillation energy (when appropriate).
Intended for use in either in-hospital or out-of-hospital settings for
emergency treatment of victims exhibiting symptoms of sudden cardiac
arrest who are unresponsive and not breathing. Recall # Z-0772-2010; 9)
Burdick Cardiovive 92532 automated external defibrillator. This
semi-automatic model requires the user to press a shock button in order
for the device to deliver defibrillation energy (when appropriate).
Intended for use in either in-hospital or out-of-hospital settings for
emergency treatment of victims exhibiting symptoms of sudden cardiac
arrest who are unresponsive and not breathing. Recall # Z-0773-2010; 10)
Burdick Cardiovive 92533 automated external defibrillator. This
semi-automatic model requires the user to press a shock button in order
for the device to deliver defibrillation energy (when appropriate).
Intended for use in either in-hospital or out-of-hospital settings for
emergency treatment of victims exhibiting symptoms of sudden cardiac
arrest who are unresponsive and not breathing. Recall # Z-0774-2010;11)
GE Responder 2019198 automated external defibrillator. This
semi-automatic model requires the user to press a shock button in order
for the device to deliver defibrillation energy (when appropriate).
Intended for use in either in-hospital or out-of-hospital settings for
emergency treatment of victims exhibiting symptoms of sudden cardiac
arrest who are unresponsive and not breathing. Recall # Z-0775-2010; 12)
GE Responder 2023440 automated external defibrillator. This
semi-automatic model requires the user to press a shock button in order
for the device to deliver defibrillation energy (when appropriate).
Intended for use in either in-hospital or out-of-hospital settings for
emergency treatment of victims exhibiting symptoms of sudden cardiac
arrest who are unresponsive and not breathing. Recall # Z-0776-10;13) NK
9231 CardioLife automated external defibrillator. This semi-automatic
model requires the user to press a shock button in order for the device
to deliver defibrillation energy (when appropriate). Intended for use in
either in-hospital or out-of-hospital settings for emergency treatment
of victims exhibiting symptoms of sudden cardiac arrest who are
unresponsive and not breathing. Recall # Z-0777-2010; 14) NK 9200G.
CardioLife automated external defibrillator. This semi-automatic model
requires the user to press a shock button in order for the device to
deliver defibrillation energy (when appropriate). Intended for use in
either in-hospital or out-of-hospital settings for emergency treatment
of victims exhibiting symptoms of sudden cardiac arrest who are
unresponsive and not breathing. Recall # Z-0778-2010
MANUFACTURER: Recalling Firm: Cardiac Science Corp., Bothell, WA, by
letter dated November 13, 2009. Manufacturer: Cardiac Science Corp.,
Deerfield, WI. Firm initiated recall is ongoing. Firm initiated recall
is ongoing.
REASON: Potential for devices not to deliver therapy.
PRODUCT:
Micron Bobbin Vent Tube, 1.27 MM I.D., Titanium, REF 145281-ENT, qty 1,
Sterile EO. Intended to be implanted for ventilation or drainage of the
middle ear. Recall # Z-0797-2010
MANUFACTURER: Recalling Firm: Gyrus ACMI Corp., Southborough, MA, by
telephone and visit on January 4, 2010 and by follow-up letter dated
January 14, 2010. Manufacturer: Gyrus ENT LLC Sub of Gyrus ACMI, Inc.,
Memphis, TN. Firm initiated recall is ongoing.
REASON: Product may have been shipped without being sterilized.
PRODUCT:
StatSpin Express 4 Horizontal Centrifuge Model # M510. Intended Use:
Rapid Separation of plasma and serum from primary gel collection tubes.
Recall # Z-0807-2010
MANUFACTURER: StatSpin, Inc., dba Iris Sample Processing, Westwood, MA,
by letter on January 26, 2010. Firm initiated recall is ongoing.
REASON: Centrifuge shield micro-switch failed due to damage, and the
unit opened, ejecting pieces.
PRODUCT:
Beckman Coulter UniCel DxC Synchron Clinical Systems. PN Numbers: A10405
(UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i);
A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC
880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871 (UniCel
DxC 860i). Intended for the in vitro determination of a variety of
general chemistries, therapeutic drugs, and other chemistries of
clinical interest in biological fluids such as serum, plasma, urine, or
cerebrospinal fluid. Recall # Z-0863-2010
MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter dated January
4, 2010. Firm initiated recall is ongoing
REASON: Excessive Buildup of protein, bacteria and sample tube additives
in the ISE flow cell may cause erroneous NA (sodium) results.
CLASS II
PRODUCT:
Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has
application in endoscopic surgery procedures. Recall # Z-1157-2010
MANUFACTURER: Recalling Firm: Covidien LP, North Haven, CT, letters
dated February 8, 2010. Manufacturer: USSC Puerto Rico, Inc., Ponce, PR.
Firm initiated recall is ongoing.
REASON: Fixation device may fail to fire and staple.
PRODUCT:
Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device
intended for stereotactic irradiation of head structures ranging from
very small target sizes of a few millimeters to several centimeters.
Recall # Z-1158-2010
MANUFACTURER: Recalling Firm: Elekta, Inc., Norcross, GA, by a field
action dated September 16, 2008 and visit. Manufacturer: Elekta
Instrument AB, Stockholm, Sweden. Firm initiated recall is complete.
REASON: Need to modify the closing speed of the shielding doors in the
event of an emergency exit.
PRODUCT:
SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog
No: FG 02550, Sterilized with gamma radiation. Intended for use in
atherectomy of the peripheral vasculature. The catheter is NOT intended
for use in the coronary or carotid vasculature. Recall # Z-1162-2010
MANUFACTURER: Recalling Firm: Ev3, Inc., Plymouth, MN, by letter dated
January 21, 2010. Manufacturer: Ev3, Inc., Irvine, CA. Firm initiated
recall is ongoing.
REASON: ev3 Inc. is conducting a voluntary recall of specific lots of
the SilverHawk Cutter Drivers (Model Number FG 02550) because of damage
to the packaging.
PRODUCT:
1) Aplio 50; SSA-700A; software version 5.5r002. Recall # Z-1171-2010;
2) Aplio 80; SSA-770A; software version 5.5r002. Z-1172-2010;
3) Xario; SSA-660A; software version 1.0 and later. Recall # Z-1173-2010
MANUFACTURER: Recalling Firm: Toshiba American Medical Systems Inc.,
Tustin CA, by letter on November 12, 2007. Manufacturer: Toshiba
Electron Tubes & Devices Co., Ltd., Otawa-Shi, Tochigi, Japan. Firm
initiated recall is ongoing.
REASON :Toshiba America Medical System Inc initiated a field corrective
action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio
80; SSA-700A; software version 5.5r002 and later, and Xario; SSA-660A;
software version 1.0 and later, because the product does not meet the
Safety Standard requirements.
PRODUCT:
1) AOS Trochanteric Nail, 9mm x 17cm x 130, Product Part Number:
1034-170. Recall # Z-1181-2010; 2) AOS Trochanteric Nail, 9mm x 20cm x
130, Product Part Number: 1034-200. Recall # Z-1182-2010; 3) AOS
Trochanteric Nail, 11mm x 17cm x 130, Product Part Number: 1036-170.
Recall # Z-1183-2010; 4) AOS Trochanteric Nail, 11mm x 20cm x 130,
Product Part Number: 1036-200. Recall # Z-1184-2010; 5) AOS Trochanteric
Nail, 13mm x 20cm x 130, Product Part Number: 1037-200. Recall #
Z-1185-2010; 6) AOS Trochanteric Nail, 11mm x 20cm x 135, Product Part
Number: 1038-200. Recall # Z-1186-2010; 7) AOS Trochanteric Nail, 10mm x
17cm x 130, Product Part Number: 1040-170. Recall # Z-1187-2010; 8) AOS
Trochanteric Nail, 10mm x 20cm x 130, Product Part Number: 1040-200.
Recall # Z-1188-2010; 9) AOS Trochanteric Nail, 12mm x 17cm x 130,
Product Part Number: 1041-170. Recall # Z-1189-2010; 10) AOS
Trochanteric Nail, 12mm x 20cm x 130, Product Part Number: 1041-200.
Recall # Z-1190-2010; 11) AOS Trochanteric Nail, 10mm x 20cm x 135,
Product Part Number: 1042-200. Recall # Z-1191-2010; 12) AOS
Trochanteric Nail, 12mm x 20cm x 135, Product Part Number: 1043-200.
Recall # Z-1192-2010
MANUFACTURER: Recalling Firm: Advanced Orthopaedic Solutions Inc.,
Torrance, CA, by letter on January 14, 2010.Manufacturer: JMG Machine
Inc., La Mirada, CA. Firm initiated recall is ongoing.
REASON :The recall was initiated after Advanced Orthopaedic Solutions
(AOS) became aware of a manufacturing defect involving the short
Trochanteric Nail, where one piece was found to be incorrectly bent.
PRODUCT:
Avanta Fluid Management Injection System, Avanta Multi-Patient
Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500
MPAT, Material number 3018231. Recall # Z-1199-2010
MANUFACTURER :Medrad, Inc., Indianola, PA, by letter dated January 6,
2010. Firm initiated recall is complete.
REASON: The product may be defective resulting in a reduction of the
saline delivery rate and inadequate air purging.
END OF ENFORCEMENT REPORT FOR MARCH 31, 2010
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
March 24, 2010
CLASS I
PRODUCT:
1) MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R)
Access Device, Integral Hemostasis Valve, Sharps Safety Features and
Maximal Barrier Precautions for use with 7 - 7.5 Fr Catheters. The
product is shipped in cases containing 5 catheters (contains Q-Syte).
Product number ASK-21242-UVA2. Recall # Z-0783-2010;
2) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath,
Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal
Barrier Precautions for use with 7.5 - 8 Fr Catheters. The product is
shipped in cases containing 5 catheters (contains Q-Syte). Product
number ASK-29803-SJH. Recall # Z-0784-2010;
3) Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R),
ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal
Barrier Precautions. The product is shipped in cases containing 5
catheters (contains Q-Syte). Product number ASK-42703-SJH. Recall #
Z-0785-2010;
4) Two-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R),
ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal
Barrier Precautions. The product is shipped in cases containing 5
catheters (contains Q-Syte). Product number ASK-42802-SHB. Recall #
Z-0786-2010;
5) Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R),
ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal
Barrier Precautions. (contains Q-Syte); Product number ASK-45703-SHB.
Recall # Z-0787-2010;
6) Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R),
ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal
Barrier Precautions. (contains Q-Syte). Recall # Z-0788-2010
MANUFACTURER: Arrow International, Inc., Reading, PA, by letter dated
November 24, 2009. Firm initiated recall is ongoing.
REASON: Q-Syte Component contained in kits was recalled by manufacturer
due to the potential for embolism if used with a central venous
catheter.
PRODUCT:
Pump Fill Kit DT10175. Contents: 1 CSR Wrap, 2 Gloves, 1 Fenestrated
Drape, 1 Extension Line Approx. Priming Vol.: 0.3mL, 1 Syringe, 1
Needle, 1 CholoraPrep(R), 1 TRAY The recalled Exel Huber Needles are
used to access subcutaneously implanted ports used for the withdrawal of
blood samples and infusion of medication. The firm places the recalled
needles in pump fill kit. Recall # Z-1140-2010
MANUFACTURER: Recalling Firm: Centurion Medical Products, Howell, MI, by
letter dated January 26, 2010. Manufacturer: Exelint International Co.,
Culver City, CA. Firm initiated recall is ongoing.
REASON: The needles that are labeled as non-coring could core 60-72% of
the time.
CLASS II
PRODUCT: Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless,
sterile; REF 904842P. Intended to be implanted for fixation of bone
fractures and for bone reconstructions. Recall # Z-0191-2010
MANUFACTURER: Recalling Firm: Biomet, Inc., Warsaw, IN, by letter dated
September 9, 2009.Manufacturer: Biomet Sports Medicine, Ontario, CA.
Firm initiated recall is ongoing.
REASON: Anchors may be difficult to remove, or may not detach from the
inserter shaft.
PRODUCT:
1) Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models
911, 912, 917 and Modular P; Catalog no. 03800504190. The product is
used for in vitro diagnostic reagent for the quantitative determination
of gentamicin in human serum or plasma on automated clinical chemistry
analyzers. Recall # Z-0970-2010;
2) Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models
917 and Modular P; Catalog no. 03500241190. The product is used for in
vitro diagnostic reagent for the quantitative determination of
gentamicin in human serum or plasma on automated clinical chemistry
analyzers. Recall # Z-0971-2010;
3) Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501
analyzer systems; Catalog no. 04490843190. The product is used for in
vitro diagnostic reagent for the quantitative determination of
gentamicin in human serum or plasma on automated clinical chemistry
analyzers. Recall # Z-0972-2010
MANUFACTURER: Roche Diagnostics Operations, Inc., Indianapolis, IN, by
letter dated October 7, 2009. Firm initiated recall is ongoing.
REASON: A high recovery of the assay may be generated, which would lead
to an underdosage of gentamicin being administered to the patient.
PRODUCT: Oxoid CM0225 Brain Heart Infusion IVD. The product is used for
the cultivation of streptococci, pneumococci, meningococci and other
fastidious organisms and is suitable for blood culture work. Recall #
Z-0979-2010
MANUFACTURER: Recalling Firm: Remel, Inc., Lenexa, KS, by letters dated
December 21, 2009.Manufacturer: Oxoid, Ltd., Basingstoke, United
Kingdom. Firm initiated recall is ongoing.
REASON: Product failure - Failure to grow quality control strains of
Streptococcus pneumonia.
PRODUCT: Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C.
Recall # Z-1018-2010
MANUFACTURER: Mainline Technology, Inc., Ann Arbor, MI, by letters dated
October 7, 2009. Firm initiated recall is ongoing.
REASON: Lack of assurance of safety and efficacy: unapproved for
marketing in the U.S., non-compliance with cGMP regulations and no
stability data to support labeled expirations dates.
PRODUCT:
1) Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent
Set; Catalog #'s HC902-576 and HC902-1000. Calcium Reagent Set for
repackaging, Catalog # HC902-SAM-911. The product is used for the
quantitative determination of calcium in serum on Hitachi analyzers.
Recall # Z-1041-2010;
2) Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC)
R1 Reagent Set; Catalog #'s HC402-R1. Calcium CPC Hitachi Reagent Set
for repackaging, Catalog # 3-HC902-R1. The product is used for the
quantitative determination of calcium in serum on Hitachi analyzers.
Recall # Z-1042-2010;
3) Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC)
R2 Reagent Set; Catalog #'s HC402-R2. Calcium CPC Hitachi Reagent Set
for repackaging, Catalog # 3-HC902-R2. The product is used for the
quantitative determination of calcium in serum on Hitachi analyzers.
Recall # Z-1043-2010
MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by letter dated
November 11, 2009. Firm initiated recall is ongoing.
REASON: Non-compliance with the Good Manufacturing Practice regulations,
as the manufacturing process for this product had not been validated.
PRODUCT: Zimmer NexGen Complete Knee Solution Minimally Invasive
Solutions Procedures Trabecular Metal Technology Tibial Tray, fixed
bearing, size 8, sterile; REF 00-5954-057-02. The product is used as an
implant for knee replacement. Recall # Z-1064-2010
MANUFACTURER: Zimmer, Inc., Warsaw, IN, by e-mails on December 1, 2009,
December 2, 2009 and December 3, 2009 and by letter on December 9, 2009.
Firm initiated recall is ongoing.
REASON: The titanium portion of the implant may separate from the
trabecular metal material.
PRODUCT: Hill-Rom TotalCare Bed; Model P1900. The product is used as an
AC powered adjustable hospital bed. Recall # Z-1065-2010
MANUFACTURER: Hill-Rom, Inc, Batesville, IN, by letter dated January 4,
2010. Firm initiated recall is ongoing.
REASON: The controls for nurse call, bed movement and entertainment
functions on the intermediate rail may fail to function.
PRODUCT: Electri-Cord AC Power Cords, IEC 60320 Coupler, Product
Reorder Number 21-2145-01 only for use with Smiths Medical CADD®-Solis
ambulatory infusion pumps, Model 2100. These cords were sold as an
accessory for these pumps under Manufacturing Number A23.164.098.0A,
Electri-Cord part Number PC2000403. Electri-Cord AC Power Cords are
accessories for use with the CADD®-Solis Ambulatory Infusion Pump. These
power cords allow users to run the pump via AC power rather than battery
power. The CADD®-Solis pump is indicated for intravenous,
intra-arterial, subcutaneous, intraperitoneal, in close proximity to
nerves, into an intraoperative site (soft tissue, body cavity/ surgical
wound site), epidural space, or subarachnoid space infusion. The pump is
intended for therapies that require a continuous rate of infusion,
patient-controlled demand doses, or both. Recall # Z-1082-2010
MANUFACTURER: Smiths Medical ASD, Inc., Saint Paul, MN, by letter dated
January 27, 2010. Firm initiated recall is ongoing.
REASON: Potential for the power cord's prongs to crack and fail at/or
inside the plug. Other medical device manufacturers have reported
incidents of sparking, charring, and fires from the affected power cords
used with their devices. Smiths Medical has received no reports of
incidents regarding the use of the affected Electri-Cord power cords
with their devices.
PRODUCT:
1) Femoral Sponge 10 inches REF 206-715, Rx Sterile. The femoral sponge
is an absorbent that is used to dry the intramedullary canal prior to
the application of bone cement. The suction effectively absorbs blood
and fluid from the canal. It may provide swabbing/scrubbing action
during suction. Recall # Z-1104-2010;
2) Bio-Prep Bone Preparation Kit with Merocel sponge for use in total
hip arthroplasty. REF 206-730, Rx, Sterile. The femoral sponge is an
absorbent that is used to dry the intramedullary canal prior to the
application of bone cement. The suction effectively absorbs blood and
fluid from the canal. It may provide swabbing/scrubbing action during
suction. Recall # Z-1105-2010;
3) Advanced Cement Mixing Bio-Prep Cement Application Kit, Rx, Sterile,
REF 306-563S10. The femoral sponge is an absorbent that is used to dry
the intramedullary canal prior to the application of bone cement. The
suction effectively absorbs blood and fluid from the canal. It may
provide swabbing/scrubbing action during suction. Recall # Z-1106-2010;
4) ACM with Femoral Brush and Femoral Sponge, Rx, Sterile, REF
306-705-000S8. The femoral sponge is an absorbent that is used to dry
the intramedullary canal prior to the application of bone cement. The
suction effectively absorbs blood and fluid from the canal. It may
provide swabbing/scrubbing action during suction. Z-1107-2010;
5) ACM Bio-Prep with Merocel pkg/6, Rx, Sterile, REF 0306-708-000S4. The
femoral sponge is an absorbent that is used to dry the intramedullary
canal prior to the application of bone cement. The suction effectively
absorbs blood and fluid from the canal. It may provide
swabbing/scrubbing action during suction. Recall # Z-1108-2010
MANUFACTURER: Recalling Firm: Stryker Instruments Div. of Stryker Corp.,
Kalamazoo, MI, by letter dated January 21, 2010.Manufacturer: Hydrofera,
LLC, Willimantic, CT. and Stryker Puerto Rico, LTD, Arroyo, PR. Firm
initiated recall is ongoing.
REASON: The firm did not have packaging validation to support the
labeled shelf life. There is potential for a breach in sterility
specific to the sterile packaged femoral sponge which may result in a
non-sterile product.
PRODUCT: PrecisePLAN 2.15 Treatment Planning System. The product is
used to plan multiple beam radiation therapy treatments. Recall #
Z-1109-2010
MANUFACTURER: Recalling Firm: Elekta, Inc., Norcross, GA, by important
notice dated May 8, 2007 and September 30, 2008. Manufacturer: Elekta
Oncology Systems (Fmrl Philipps), West Sussex, UK. Firm initiated recall
is ongoing.
REASON: The new "DICOM CT with Body Outline" method to create a patient
case in PrecisePLAN 2.15 may produce incorrect results for some
customers, given several input conditions encountered in the field.
Discontinue use of this method of creating a patient case until FCO 772
00 540 064, (entitled "Update for Patient creation method using DICOM CT
with Body Outline"), is received from Elekta to update this utility.
This problem only applies to customers using the "DICOM CT with Body
Outline" method of creating a patient case and this option is only
available in release 2.15 of PrecisePLAN. The "DICOM CT" method in
release 2.15 and previous releases of PrecisePLAN is not affected by
this problem (see User Manual section 3.2.2). The Field Change Order
details the prerequisites and installation instructions for upgrading
PrecisePLAN users to the new release, 2.16 (Linux customers) or 2.12
(SGI customers).
PRODUCT: The Martel Printer is an accessory to the i-STAT Portable
clinical Analyzer (model 300). The i-STAT Analyzer is used by trained
medical professionals for running a variety of clinical chemistry tests
and test panels contained in i-STAT test cartridges. These tests include
Hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride,
ionized calcium, blood gases (oxygen, carbon dioxide, and pH),
Creatinine, lactate and activated clotting time. List number
06F23-91/111300; Abbott list number: 06F23-91. Recall # Z-1133-2010
MANUFACTURER: Abbott Point of Care, Inc., Princeton, NJ, by letter dated
October 2009. Firm initiated recall is ongoing.
REASON: Some Martel Printers used with the i-STAT 1 system have the
potential of being damaged due to the use or rechargeable battery packs
that do not contain a fuse.
PRODUCT: Philips Switched Internal Defibrillator Paddles (used with
Philips HeartStart XL and HeartStart MRx monitor/defibrillators) Models:
M4741A - Extra Large Switched internal Paddles M4742A - Large Switched
internal Paddles M4743A - Medium Switched internal Paddles M4744A -
Small Switched internal Paddles. Recall # Z-1135-2010
MANUFACTURER: Philips Healthcare, Inc., Andover, MA, by letter on
January 25, 2010. Firm initiated recall is ongoing.
REASON: Paddle shock switch may fail to actuate and delay or prevent
delivery of defibrillation therapy.
PRODUCT: PTS Panels Lipids Panel test strips for self-testing or
professional use with CardioChek P-A analyzers; Catalog # 1710. Recall #
Z-1136-2010
MANUFACTURER: Polymer Technology Systems, Inc., Indianapolis, IN, by
letter dated June 5, 2009. Firm initiated recall is complete.
REASON: Exhibits under-recovery of all analytes.
PRODUCT:
1) Modified Novy Cornual Cannulation Set with clear tip, G17558, REF
J-NCS-504070, Cook OB/GYN. Recall # Z-1137-2010;
2) Modified Novy Cornual Cannulation Set with clear tip, G17558, REF
J-NCS-504070, Cook OB/GYN. Recall # Z-1138-2010
MANUFACTURER: Cook Women’s Health, Spencer, IN, by letters dated January
8, 2010. Firm initiated recall is ongoing.
REASON: The distal tip may separate from the catheter while the catheter
is in the patient.
PRODUCT:
remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref
12402, 10/pk, each Tyvek pouch contains 1 tube of medium and 1
rayon-tipped sterile swab. Product is a sterile system recommended for
use in qualitative procedures for the collection of clinical specimens
and transport to the laboratory for microbiological culture of
anaerobic, facultative, and aerobic organisms. Recall # Z-1139-2010
MANUFACTURER: Remel, Inc., Lenexa, KS, by letter dated January 18, 2010.
Firm initiated recall is ongoing.
REASON: Pouch may be inadequately heat sealed compromising sterility.
PRODUCT:
Neutralect Diathermy Cable, Unomedical Ltd., Ref code 3508M, and Ref
Code 3405M. No expiration dates. Recall # Z-1142-2010
MANUFACTURER: Recalling Firm: ConvaTec, Skillman, NJ, by letters on
January 22, 2010.Manufacturer: Unomedical, Ltd. Stonehouse, Glos, UK.
Firm initiated recall is ongoing.
REASON: Mislabeling: Boxes labeled with the order code 3508M may contain
a cable for the order code 3405M, and boxes labeled with order code
3405M may contain a cable for order code 3508M.
PRODUCT: Ventana Pathway anti-Her-2/NEU (4B5) Rabbit Monoclonal Primary
Antibody (Pathway HER2 (4B5); Model Number: 790-2991, in vitro
diagnostic. Recall # Z-1146-2010
MANUFACTURER: Ventana Medical Systems, Inc., Tucson, AZ, by letter on
September 17, 2009. Firm initiated recall is ongoing.
REASON: Light staining inconsistencies.
PRODUCT:
1) Paraffin Pretreatment Reagent Kit II; each kit contains the
following: 5 x 50 mL Pretreatment Solution (sodium thiocyanate - NaSCN),
5 x 62.5 mL Protease Buffer II (0.2N HCl), 5 x 250 mg Protease I
(Pepsin, lyophilized, activity 1:3000 to 1:3500); Abbott Molecular Inc;
list 07J02-002, part number 32-801210. invitro diagnostic. Recall #
Z-1147-2010;
2) Paraffin Pretreatment Reagent Kit III; each kit contains the
following: 5 x 50 mL Pretreatment Solution (1N sodium thiocyanate -
NaSCN), 5 x 62.5 mL Protease Buffer III (50 mM Tris base, pH 8.0 5 mM
Calcium Chloride - 2H2O 0.1% SDS), 5 x 9.0 mg Protease III (Proteinase
K, 35 <= x <= 38 Units/mg) 2 x 200 mL Protease Stop Solution (0.01N
hydrochloric acid - HCl); Abbott Molecular Inc; list 07J02-003, part
number 32-801230. invitro diagnostic. Recall # Z-1148-2010
MANUFACTURER: Abbott Molecular, Des Plaines, IL, by letters dated
January 21, 2010. Firm initiated recall is ongoing.
REASON: The Paraffin Pretreatment Reagent kits do not have any hazardous
or MSDS information included in their labeling.
PRODUCT: Bond-1 Primer/Adhesive. The intended use of this device is
adhesion to dentin of various polymeric filling materials (composites)
used with other conditioners or combination of conditioners for bonding
of composite to metal including amalgam, gold, semi-precious and
non-precious alloys, porcelain and glass and luting of same to Dentin
and Enamel. Recall # Z-1150-2010
MANUFACTURER: Recalling Firm: Sybron Dental Specialties, Orange, CA, by
letter on August 24, 2009.Manufacturer: Pentron Clinical Technologies,
Wallingford, CT. Firm initiated recall is ongoing.
REASON: Some of the material has been found to be gelled and therefore
becomes unusable.
PRODUCT: Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack
box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress
Chemistry Analyzer, Catalog No. 400-0028. Medical device for use in the
in vitro quantitative determination of alanine aminotransferase (ALT),
albumin, alkaline Phosphatase (ALP), aspartate aminotransferase,
calcium, chloride, creatinine, glucose, potassium, sodium, total
bilirubin, total carbon dioxide, total protein, and blood urea nitrogen
in heparinized whole blood, heparinized plasma or serum. Recall #
Z-1155-2010
MANUFACTURER: Abaxis, Inc., Union City, CA, by letter dated November 16,
2009. Firm initiated recall is ongoing.
REASON: Wrong barcode applied to a lot of items, which may result in
incorrect calibration factors and results.
PRODUCT: Elekta SL Series/Precise Digital Accelerator. The product is
used with radiation therapy treatment of malignant neoplastic diseases,
as determined by a licensed medical practitioner. a) Model SL15; b)
Model SL18; c) Model SL25; d) Model PRECISE ACC; e) Model SYNERGY PLAT;
f) Model SL20; g) Model SL75/5; h) Model SL1+; i) Model SL1; j) Model
SL75/20. Recall # Z-1159-2010
MANUFACTURER: Recalling Firm: Elekta, Inc., Norcross, GA, by letter
dated November 18, 2005.Manufacturer: Elkta Oncology Systems (Fmrl
Phillipps), Crawley, West Sussex, UK. Firm initiated recall is complete.
REASON: Customer reported larger than expected variations in wedge
factory with gantry rotation.
PRODUCT: Thermoflect Product Line including items for adults and
pediatrics. Recall # Z-1175-2010
MANUFACTURER: Recalling Firm: Encompass Group LLC, McDonough, GA, by
letters on/about December 23, 2009 and press release on/about December
26, 2009.
Manufacturer: Encompass Therapeutic Support Systems dba BG - North
America, Glendale, CA. Firm initiated recall is ongoing.
REASON: The products are not compatible for use in the Magnetic
Resonance Imaging (MRI) environment.
PRODUCT: Image Consultant (IC) Software. Recall # Z-1176-2010
MANUFACTURER: Recalling Firm: R. O. Golden & Co., Inc., Elkins Park, PA,
by letters on February 5, 2010.Manufacturer: Unique Media, Canton, PA.
Firm initiated recall is ongoing.
REASON: Software not validated.
CLASS III
PRODUCT: PTS Panels LDL Cholesterol test strips for professional use
with CardioChek P-A test systems; Catalog No. 1753. For the quantitative
measurement of LDL cholesterol in whole blood. Recall # Z-1132-2010
MANUFACTURER: Polymer Technology Systems, Inc., Indianapolis, IN, by
letter dated May 29, 2009. Firm initiated recall is complete.
REASON: The expiration date was extended by 20 weeks without
justification.
PRODUCT: BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96
Tests...2010 02 16. Positive Control included in lot is identified as
"REF 425-2025". in vitro diagnostic. Recall # Z-1145-2010
MANUFACTURER: Bio-Rad Laboratories, Inc., Hercules, CA, by letter on
July 14, 2009. Firm initiated recall is ongoing.
REASON: The firm received customer complaints of microbial contamination
in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863v.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
March 17, 2010
CLASS I
PRODUCT:
1) Baxter HomeChoice Automated Peritoneal Dialysis Systems; Made in
U.S.A; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, and
T5C4441R. The HomeChoice dialysis system is a personal cycler automated
peritoneal dialysis system for pediatric and adult renal patients with
fill volumes ranging from 60 mL to 3000 mL. Recall # Z-0799-2010;
2) HomeChoice PRO Automated Peritoneal Dialysis Systems; Made in U.S.A.;
Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and
T5C8300R. The HomeChoice dialysis system is a personal cycler automated
peritoneal dialysis system for pediatric and adult renal patients with
fill volumes ranging from 60 mL to 3000 mL. The HomeChoice PRO model has
a PRO card, a small electronic data card, which stores information from
the nurse or doctor and automatically sets up the system for the
patient. Recall # Z-0800-2010
MANUFACTURER: Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw Park,
IL, by letters dated January 8, 2010 and January 12, 2010Manufacturer:
Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is
ongoing.
REASON: Potential overfill of the peritoneal cavity, also referred to as
Increased Intraperitoneal Volume (IIPV). IIPV can result in serious
injury or death
CLASS II
PRODUCT:
i-STAT 1 Analyzer, Product of USA. The product is intended to be used by
trained medical professionals for use with i-STAT test cartridges and
MediSense blood glucose test strips. i-STAT cartridges comprise a
variety of clinical chemistry tests and test panels. Catalog number
06F16-10. Recall # Z-0812-2010
MANUFACTURER: Abbott Point of Care, Inc., Princeton, NJ, by letter
during September 2009. Firm initiated recall is ongoing.
REASON: The storage temperature on the label on the side of the i-Stat
Portable Clinical Analyzer shipping box does not match product
specification.
PRODUCT:
Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565.
Not Sterile; Intended for use in the non-cervical spine. Recall #
Z-0823-2010
MANUFACTURER: Recalling Firm: Stryker Spine, Allendale, NJ, by letter
dated January 15, 2010.Manufacturer: Stryker Spine, Aquitane, France.
Firm initiated recall is ongoing.
REASON: The Xia 3 8.5mm Polyaxial screws, lot A91109 were anodized
turquoise instead of Fuchsia. The turquoise color is reserved for the
9.5 mm Xia 3 screws.
PRODUCT:
Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S.
Recall # Z-0825-2010
MANUFACTURER: Synthes USA (HQ), Inc., West Chester, PA, by letter dated
January 8, 2010. Firm initiated recall is ongoing
REASON: There is the potential for the bender/cutter attachment to
continue heating after release of the power button. There is potential
for patient and/or staff injury if continuous heating is unrecognized
PRODUCT:
1) Stryker T2 Ankle Arthrodesis Nail, left; 010 x 300 mm; Catalog number
18181030S; Sterile, TI Alloy; Intended for tibiotalocalcaneal
arthrodesis (fusion) and to provide stabilization of the hindfoot and
ankle including the transverse tarsal joints coupling the mid-foot to
the hindfoot. Recall # Z-0841-2010;
2) Stryker T2 Ankle Arthrodesis Nail, left; 011 x 300 mm; Catalog
Number: 18181130S; Sterile, TI Alloy. Intended for tibiotalocalcaneal
arthrodesis (fusion) and to provide stabilization of the hindfoot and
ankle including the transverse tarsal joints coupling the mid-foot to
the hindfoot. Recall # Z-0842-2010;
3) Stryker T2 Ankle Arthrodesis Nail, left; 012 x 300 mm; Catalog
number: 18181230S; Sterile, TI Alloy. Intended for tibiotalocalcaneal
arthrodesis (fusion) and to provide stabilization of the hindfoot and
ankle including the transverse tarsal joints coupling the mid-foot to
the hindfoot. Recall # Z-0843-2010;
4) Stryker T2 Ankle Arthrodesis Nail, right; 010 x 300 mm; Catalog
number: 18191030S; Sterile, TI Alloy. Intended for tibiotalocalcaneal
arthrodesis (fusion) and to provide stabilization of the hindfoot and
ankle including the transverse tarsal joints coupling the mid-foot to
the hindfoot. Recall # Z-0844-2010;
5) Stryker T2 Ankle Arthrodesis Nail, right; 011 x 300 mm; Catalog
number: 18191130S; Sterile, TI Alloy. Intended for tibiotalocalcaneal
arthrodesis (fusion) and to provide stabilization of the hindfoot and
ankle including the transverse tarsal joints coupling the mid-foot to
the hindfoot. Recall # Z-0845-2010
6) Stryker T2 Ankle Arthrodesis Nail, right; 012 x 300 mm; Catalog
number: 18191230S; Sterile, TI Alloy; Intended for tibiotalocalcaneal
arthrodesis (fusion) and to provide stabilization of the hindfoot and
ankle including the transverse tarsal joints coupling the mid-foot to
the hindfoot. Recall # Z-0846-2010
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah,
NJ, letters on December 29, 2009 and January 11, 2009.
Manufacturer: Stryker Trauma GmbH, Schonkirchen, Germany. Firm initiated
recall is ongoing.
REASON: Stryker Orthopedics became aware that there is the potential for
damage to the sterile packaging of the product during transport.
PRODUCT:
1) Coulter LH SlideMaker, LH Barcode Specification, LH SM Intended Use,
LH Slide and Sample Flow, Part Number 6605633, P/N 4277248, 4277299, and
277299. Intended for use as an optional peripheral to the Beckman
Coulter LH 700 Series System. Creates a blood smear on a clean
microscope slide using a segment of the blood sample aspirated by the LH
700 Series. Recall # Z-0850-2010;
2) GEN*S SlideMaker, Barcode Label Specifications, GEN*S SM Intended
Use, GEN*S Slide and Sample, Part Numbers 6605360, P/N 4237221, 4237212,
and 4277299. Intended for use as an optional peripheral to the COULTER
GEN*S System. Creates a blood smear on a clean microscope slide using a
segment of the blood sample aspirated by the GEN*S System. Recall #
Z-0851-2010
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter
dated June 9, 2008.Manufacturer: Beckman Coulter Inc., Fullerton, CA.
Firm initiated recall is ongoing.
REASON: The Sample ID information embedded in the barcode affixed to a
slide made by the Coulter GEN*S and LH SlideMaker does not match the
text.
PRODUCT:
1) Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL
Cholesterol Reagent Set; Catalog # H7511-60 and Catalog # H7511-SAM. HDL
Cholesterol Reagent Set, (Clinical chemistry). For the quantitative
determination of high density lipoprotein (HDL) in cholesterol in serum.
Recall # Z-0859-2010;
2) Liquid HDL (PEG) Cholesterol Reagent; Catalog # 7-H7511-30,
8-H7511-30, 3-H-7511-L. (Clinical chemistry). For the quantitative
determination of high density lipoprotein (HDL) in cholesterol in serum.
Recall # Z-0860-2010
MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by letter dated
November 10, 2009. Firm initiated recall is ongoing.
REASON: The firm initiated the recall due to the presence of visible
contamination of the product.
PRODUCT:
Variant II Turbo Hemoglobin A1c Program, model number 270 2417. Intended
Use: For the percent determination of hemoglobin A1c in human whole
blood using ion-exchange high-performance liquid chromatography (HPLC).
Recall # Z-0867-2010
MANUFACTURER: Bio-Rad Laboratories, Inc., Hercules, CA, by telephone and
fax on October 12, 2009 and by letter dated October 13, 2009. Firm
initiated recall is ongoing
REASON: Product update kit CD rom will not upload. As a result, the
device cannot be run.
PRODUCT:
PTS Panels Cholesterol test strips for self-testing or professional use
with CardioChek analyzers, Catalog # 1711. Intended to provide a
quantitative measurement of total cholesterol in whole blood. Recall #
Z-0871-2010
MANUFACTURER: Polymer Technology Systems, Inc., Indianapolis, IN., by
letter dated April 2, 2009. Firm initiated recall is ongoing.
REASON: The memory chip was coded with incorrect product information
PRODUCT:
1) Trident Acetabular Hip System Polyethylene Inserts, Stryker
Orthopaedics, multiple sizes. Intended for use in cementless fixation
fro use in total hip arthroplasty to relieve pain and restore function
in the hip. Recall # Z-0909-2010
2) Triathlon X3 UHMWPE Tibial Inserts and Patellar Components, multiple
sizes. Intended to be used with femoral components in primary or
revision total knee arthroplasty. Recall # Z-0910-2010;
3) Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar
Components, multiple sizes. Intended to be used with cemented or
cementless components in primary or revision total knee arthroplasty.
Recall # Z-0911-2010
MANUFACTURER: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter
dated February 17, 2007. Firm initiated recall is complete.
REASON: A potential anomaly related to the packaging process of
referenced lots of X# polyethylene used on Scorpio, Triathlon and
Trident inserts.
PRODUCT:
1) Pointe Scientific Uric Acid (Liquid) Reagent Set; Catalog # HU782-246
and HU982-615. For the quantitative determination of uric acid in serum
on Hitachi analyzers. For in-vitro diagnostic use only. Recall #
Z-0912-2010;
2) Pointe Scientific Liquid Uric Acid (R1) Reagent Set; Catalog #
HU482-R1. For the quantitative determination of uric acid in serum on
Hitachi analyzers. For in-vitro diagnostic use only. Recall #
Z-0913-2010
MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by letter dated
December 1, 2009. Firm initiated recall is ongoing
REASON: A process deviation occurred during the production of the R1
component which may affect its performance
PRODUCT:
Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay
Systems, UniCel DxI 600 Access Immunoassay Systems, UniCel DxC 880i
SYNCHRON Access Clinical Systems. Intended to be used with the Access
Immunoassay System to remove waste from the system. Pump Part Numbers
A62712, A62839, A62840, A62841, and A63124; Instrument Part Numbers:
973100, A30260, and A59102. Recall # Z-0914-2010
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, letter
dated October 16, 2008. Manufacturer: Beckman Coulter Inc.,
Fullerton, CA. Firm initiated recall is ongoing.
REASON: A new premature failure of the upper aspirate peristaltic pump
in the systems listed above. Premature failure of the pump may
negatively affect precision. The failure is limited to those UniCel DXI
800, DXI 600, and DxC 880i systems which have a pump identified with one
of the new pump manufacturing numbers (Mfg. Nos.) listed above. The
upper peristaltic pump assembly may not maintain a proper flow rate.
PRODUCT:
Sealapex Express, Part Number: 33639, root canal filling material.
Intended as a root canal filling material that is used in conjunction
with gutta percha or silver endodontic points. Recall # Z-0917-2010
MANUFACTURER: Recalling Firm: Sybron Dental Specialties, Orange, CA, by
letter dated February 19, 2009.
Manufacturer: Sybron Dental Specialties Inc., Glendora, CA. Firm
initiated recall is complete
REASON: Sybron Dental Specialties is initiating a recall on the Sealapex
Xpress due to the presence of crystals in the catalyst. This
crystallization may affect proper canal filling by preventing Gutta
Percha Points from reaching the bottom of the root canal which may lead
to an inadequate seal.
PRODUCT:
OvuChek Saliva Ovulation Disposable Test Strips; 5 disposable test
strips per pouch, packaged in a box with a specimen cup and instructions
for use, 12 boxes per case; a rapid colorimetric indicator for the
qualitative changes (ferning) of salt content in saliva to aid in the
prediction of ovulation; Manufacturer: A rapid saliva indicator for the
qualitative prediction of favorable and unfavorable fertile days in
women's menstrual cycles. UPC 8 50877 00055 5. Recall # Z-0968-2010
MANUFACTURER: Recalling Firm: Quest Products, Libertyville, IL, by
telephone and e-mail on November 7, 2008Manufacturer: Integrated
Biomedical Technology, Inc., Elkhart, IN. Firm initiated recall is
complete.
REASON: The ovulation test strips were shipped without 510(k) premarket
notification clearance from the FDA.
PRODUCT:
"K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for
use on automated clinical chemistry analyzers by laboratories. It is
used for the calibration of the K-ASSAY CRP (3) immunoturbidimetric
assay for quantifying C-Reactive Protein (CRP) in serum and plasma
(sodium EDTA or lithium heparin) samples. It is for in vitro diagnostic
use. Catalog number: "KAI-084C". Recall # Z-0973-2010
MANUFACTURER: Kamiya Biomedical Co., LLC, Tukwila, WA, by telephone on
May 1, 2009, e-mail on May 4, 2009 and letter dated May 13, 2009. Firm
initiated recall is complete.
REASON: The long-term stability of level 2 (1.0 mg/dL) may not be within
the specifications due to a decrease in CRP concentration
PRODUCT:
1) Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 100- and
500-ml. bottles and a 6x100-ml. bottle package. This medium facilitates
rapid recovery of viable mononuclear cells from small volumes of blood.
The Histopaque-1077 procedure is suitable for studying cell-mediated
lympholysis and for human lymphocyte antigen (HLA) typing. It may also
be employed as the initial isolation step prior to enumeration of T-, B-
and "null lymphocytes. Recall # Z-0976-2010;
2) Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml.
bottles and 6x100-ml. bottle packages. The product is for use in
separating mononuclear cells and granulocytes when used with
Histopaque-1077. Recall # Z-0977-2010
MANUFACTURER: Sigma-Aldrich Mfg LLC, Saint Louis, MO, by letter dated
December 7, 2009. Firm initiated recall is ongoing.
REASON: Instructions for Use (IFU) was revised to recommend sterile
filtering of the product under certain circumstances.
CLASS III
PRODUCT:
Herculite Ultra (Part Number 34333), dental composite resorative
material. Recall # Z-0916-2010
MANUFACTURER: Sybron Dental Specialties, Orange, CA, by letter dated
February 23, 2009. Firm initiated recall is complete.
REASON: Sybron Dental Specialties is initiating a field correction on
the Herculite Ultra, a dental composite restorative material, due to a
mistake in the directions for use located in the Herculite technique
card.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
March 10, 2010
CLASS I
PRODUCT:
1) BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100. Recall #
Z-0750-2010;
2) BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF
385101. Recall # Z-0751-2010;
3) BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102. Recall #
Z-0752-2010;
4) BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108. Recall #
Z-0753-2010;
5) MPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte,
REF 385150. Recall # Z-0754-2010;
6) MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF
385151. Recall # Z-0755-2010;
7) MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte,
REF 385164. Recall # Z-0756-2010;
8) BD Nexiva Closed IV Catheter System, REF 383530, 24GA 0.56IN. Recall
# Z-0829-2010;
9) BD Nexiva Closed IV Catheter System, REF 383531, 24GA 0.75IN. Recall
# Z-0830-2010;
10) BD Nexiva Closed IV Catheter System, REF 383532, 22GA 1.00IN. Recall
# Z-0831-2010;
11) BD Nexiva Closed IV Catheter System, REF 383533, 20GA 1.00IN. Recall
# Z-0832-2010;
12) BD Nexiva Closed IV Catheter System, REF 383534, 20GA 1.25IN. Recall
# Z-0833-2010;
13) BD Nexiva Closed IV Catheter System, REF 383536, 20GA 1.00IN. Recall
# Z-0834-2010;
14) BD Nexiva HF Closed IV Catheter System, REF 383537, 20GA 1.25IN.
Recall # Z-0835-2010;
15) BD Nexiva Closed IV Catheter System, REF 383538, 20GA 1.75IN. Recall
# Z-0836-2010;
16) BD Nexiva Closed IV Catheter System, REF 383539, 18GA 1.25IN. Recall
# Z-0837-201;
17) BD Nexiva Closed IV Catheter System, REF 383540, 18GA 1.75IN. Recall
# Z-0838-2010;
18) BD Nexiva Closed IV Catheter System, REF 383647, 20GA 1.25IN. Recall
# Z-0839-2010;
19) BD Nexiva Closed IV Catheter System, REF 383649, 18GA 1.25IN. Recall
# Z-0840-2010
MANUFACTURER: Becton Dickinson Medical Systems, Sandy, UT, by letters on
October 28, 2009 and February 8, 2010. Firm initiated recall is ongoing.
REASON: Manufacturing defect may allow air entry into a central venous
catheter, possibly resulting in an air embolism.
CLASS II
PRODUCT:
1) AC power cords used with either Bair Paws Temperature Management
Units: Models 850 and 875 Bair Hugger Temperature Management Units:
Models 500/OR, 505, 750 and 775 Indicated for hyper- or hypothermic
patients or normothermic patients, for whom induced hyper- hypothermia
or localized temperature therapy is clinically indicated. In addition,
the temperature management systems can be used to provide patient
thermal comfort when conditions exist that may cause patients to become
too warm or too cold. The temperature management system can be used with
adult and pediatric patients. Recall # Z-0895-2010;
2) AC power cords used with Ranger Blood/Fluid Warming Unit: Model 245.
Intended to warm blood, blood products and liquids. Part number 502221
Model 90024. Recall # Z-0896-2010;
3) AC power cords used with Ranger Irrigation Fluid Warming Unit; Model
247. Intended to warm irrigation fluids. Part number 502221 Model 90024.
Recall # Z-0897-2010;
4) AC power cords used with Ranger Pressure Infusion Power Pack; Model
90033. To provide power to pressure infusers. Part number 502221 Model
90024. Recall # Z-0898-2010
MANUFACTURER: Arizant Inc., Eden Prairie, MN, by letter dated December
17, 2009. Firm initiated recall is ongoing.
REASON: This recall is being issued in response to a small number of
customer reports of melting, smoking or fire within the power cord plug.
However, the potential risks from this power cord failure include
electric shock, delay in setup and therapy, interruption of therapy,
device failure, and fires.
PRODUCT: NextGen Knee Gender Solutions CR-Flex Femoral Component,
Precoat, Size D, Left. 00-5750-014-01. Recall # Z-0915-2010
MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letters on January 12, 2010
and January 27, 2010. Firm initiated recall is ongoing.
REASON: The package should contain the left knee component but actually
contains the right knee component. Delay in completing surgery may
result, and a new or different implant may need to be identified.
PRODUCT:
1) 9200 Advisor Vital Signs Monitor utilizes the power cord WW3005.
Recall # Z-0918-2010;
2) BCI 3180 Pulse Oximeter utilizes the power cord WW3005. Recall #
Z-0919-2010;
3) 8400 Capnocheck Capnometer utilizes the power cord 8404 for its
battery charger 330. Recall # Z-0920-2010
MANUFACTURER: Smiths Medical PM, Inc., Waukesha, WI, by letter dated
January 12, 2010. Firm initiated recall is ongoing.
REASON: Smiths Medical is conducting a voluntary recall of a limited
number of medical device AC power cords, manufactured by Electri-Cord
Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200
Advisor Vital Signs Monitor(Human or Veterinary), 8400 Capnocheck II
Capnometer(Human or Veterinary) and V6400 Invasive Pressure Monitor
(Veterinary). The affected Electri-Cord AC power cords are equipped with
a plug that has prong and ground-pin insert design and a black plastic
bridge connecting the terminal prongs on the plug. The FDA has reported
that two medical device manufactures have reported incidents of
sparking, charring, and fires from the affected power cords used with
their devices. Smiths medical has received no reports of incidents
regarding the use of the affected Electric-Cord power cords with their
devices.
PRODUCT:
1) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDICAL/TIGHT LATERAL, A/P 38
MM, M/L 24 MM, REF 71422221, FOR CEMENTED USE ONLY, QTY: (1), STERILE.
Recall # Z-0924-2010;
2) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 42 MM,
M/L 25 MM, REF 71422222, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
Recall # Z-0925-2010;
3) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 46MM,
M/L 27 MM, REF 71422223, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
Recall # Z-0926-2010;
4) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 49 MM,
M/L 29 MM, REF 71422224, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
Recall # Z-0927-2010;
5) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 52 MM,
M/L 30 MM, REF 71422225, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
Recall # Z-0928-2010;
6) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 55 MM,
M/L 32 MM, REF 71422226, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
Recall # Z-0929-2010;
7) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 42 MM,
M/L 25 MM, REF 71422232, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
Recall # Z-0930-2010;
8) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 46 MM,
M/L 27 MM, REF 71422233, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
Recall # Z-0931-2010;
9) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 49 MM,
M/L 29 MM, REF 71422234, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
Recall # Z-0932-2010;
10) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 52
MM, M/L 30 MM, REF 71422235, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
Recall # Z-0933-2010;
11) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 55
MM, M/L 32 MM, REF 71422236, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.
Recall # Z-0934-2010;
12) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM,
M/L 24 MM, REF 71422241, QTY: (1), STERILE EO. Recall # Z-0935-2010;
13) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM,
M/L 24 MM, REF 71422243, QTY: (1), STERILE EO. Recall # Z-0936-2010;
14) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM,
M/L 24 MM, REF 71422244, QTY: (1), STERILE EO. Recall # Z-0937-2010;
15) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM,
M/L 24 MM, REF 71422245, QTY: (1), STERILE EO. Recall # Z-0938-2010;
16) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM,
M/L 24 MM, REF 71422246, QTY: (1), STERILE EO. Recall # Z-0939-2010;
17) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM,
M/L 24 MM, REF 71422247, QTY: (1), STERILE EO. Recall # Z-0940-2010;
18) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM,
M/L 24 MM, REF 71422248, QTY: (1), STERILE EO. Recall # Z-0941-2010;
19) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM,
M/L 27 MM, REF 71422251, QTY: (1), STERILE EO. Recall # Z-0942-2010;
20) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM,
M/L 27 MM, REF 71422252, QTY: (1), STERILE EO. Recall # Z-0943-2010;
21) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM,
M/L 27 MM, REF 71422253, QTY: (1), STERILE EO. Recall # Z-0944-2010;
22) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM,
M/L 27 MM, REF 71422254, QTY: (1), STERILE EO. Recall # Z-0945-2010;
23) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM,
M/L 27 MM, REF 71422255, QTY: (1), STERILE EO. Recall # Z-0946-2010;
24) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM,
M/L 27 MM, REF 71422256, QTY: (1), STERILE EO. Recall # Z-0947-2010;
25) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM,
M/L 27 MM, REF 71422257, QTY: (1), STERILE EO. Recall # Z-0948-2010;
26) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM,
M/L 27 MM, REF 71422258, QTY: (1), STERILE EO. Recall # Z-0949-2010;
27) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM,
M/L 30 MM, REF 71422261, QTY: (1), STERILE EO. Recall # Z-0950-2010;
28) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM,
M/L 30 MM, REF 71422262, QTY: (1), STERILE EO. Recall # Z-0951-2010;
29) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM,
M/L 30 MM, REF 71422263, QTY: (1), STERILE EO. Recall # Z-0952-2010;
30) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM,
M/L 30 MM, REF 71422264, QTY: (1), STERILE EO. Recall # Z-0953-2010;
31) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM,
M/L 30 MM, REF 71422265, QTY: (1), STERILE EO. Recall # Z-0954-2010;
32) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM,
M/L 30 MM, REF 71422266, QTY: (1), STERILE EO. Recall # Z-0955-2010;
33) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM,
M/L 30 MM, REF 71422267, QTY: (1), STERILE EO. Recall # Z-0956-2010;
34) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM,
M/L 30 MM, REF 71422268, QTY: (1), STERILE EO. Recall # Z-0957-2010;
35) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM,
M/L 27 MM, REF 71933296, QTY: (1), STERILE EO. Recall # Z-0958-2010;
36) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM,
M/L 27 MM, REF 71933297, QTY: (1), STERILE EO. Recall # Z-0959-2010;
37) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM,
M/L 27 MM, REF 71933298, QTY: (1), STERILE EO. Recall # Z-0960-2010;
38) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM,
M/L 27 MM, REF 71933299, QTY: (1), STERILE EO. Recall # Z-0961-2010;
39) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM,
M/L 30 MM, REF 71933300, QTY: (1), STERILE EO. Recall # Z-0962-2010;
40) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM,
M/L 30 MM, REF 71933301, QTY: (1), STERILE EO. Recall # Z-0963-2010;
41) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM,
M/L 30 MM, REF 71933302, QTY: (1), STERILE EO. Recall # Z-0964-2010;
42) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM,
M/L 30 MM, REF 71933303, QTY: (1), STERILE EO. Recall # Z-0965-2010;
43) JOURNEY " UNI TIBIAL BASEPLATE RIGHT MEDIAL/ LEFT LATERAL, A/P 38
MM, M/L 24 MM, REF 71422231, FOR CEMENTED USE ONLY, QTY: (1), STERILE.
Recall # Z-0966-2010;
44) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ LEFT LATERAL, A/P 38 MM,
M/L 24 MM, REF 71422242, Qty: (1), Sterile EO. Recall # Z-0967-2010
MANUFACTURER: Smith & Nephew, Inc., Memphis, TN, by letter on December
23, 2009 and by e-mail and telephone on January 23, 2010. Firm initiated
recall is ongoing.
REASON: The firm has received complaints of the base plates breaking in
situ. If a breakage occurs, the broken base plate must be revised and/or
changed. If left unrevised a broken base could lead to instability and
premature wear of the construct.
PRODUCT: BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry
Transport System-Pink Cap, Catalog number 440476, packed in shelfpack
unit of 100 swabs. Recall # Z-0969-2010.
MANUFACTURER: Recalling Firm: Becton Dickinson & Co., Sparks, MD, by
letter on September 18, 2009.Manufacturer: Becton Dickinson Vascular
Access S.A. de C.V., Nogales, Sonora, Mexico. Firm initiated recall is
ongoing.
REASON: Product was shipped beyond its expiration date.
PRODUCT: Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml.
bottles. This medium facilitates rapid recovery of viable mononuclear
cells from small volumes of blood. The Histopaque-1077 procedure is
suitable for studying cell-mediated lympholysis and for human lymphocyte
antigen (HLA) typing. It may also be employed as the initial isolation
step prior to enumeration of T-, B- and "null" lymphocytes. Recall #
Z-0974-2010.
MANUFACTURER: Sigma-Aldrich Mfg LLC, Saint Louis, MO, by letter dated
September 4, 2009. Firm initiated recall is ongoing.
REASON: Some of the product was contaminated with Pseudomonas mendocina.
PRODUCT: Dimension Vista System BUN Flex Reagent Cartridge, Catalog
number K1021, in vitro diagnostic. Recall # Z-1017-2010
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by
letter dated June 16, 2009. Firm initiated recall is complete.
REASON: Incorrect result: patient sample BUN results reported may be
higher or lower than actual level.
PRODUCT: 1) SmartInfuser PainPump, part numbers P49230, P49220,
P49224-D, P49224N, P49230-D and P49234. Recall # Z-1021-2010;
2) SmartBlock Pain Management System, Part numbers P49524, P49534,
P49624, and P49634. Recall # Z-1022-2010.
MANUFACTURER: Recalling Firm: Hsmg, Inc., D/b/a Smartinfuser USA,
Houston, TX, by letters on January 8, 2009 and January 22, 2009.
Manufacturer: Medical Flow Systems, LTD, Shlomi, Israel. Firm initiated
recall is ongoing.
REASON: Product leaks associated with a new pump reservoir, and incident
related to regulator fast priming feature.
PRODUCT:
1) Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL.
Recall # Z-1030-2010;
2) Exacta Mix TPN (total parenteral nutrition) Bag, Model 739, 1000mL.
Recall # Z-1031-2010;
3) Exacta Mix TPN (total parenteral nutrition) Bag, Model 740, 2000.
Recall # Z-1032-2010
MANUFACTURER: Baxa Corp., Englewood, CO, by letter on November 12, 2009
and November 17, 2009. Firm initiated recall is ongoing.
REASON: TPN bags may leak fluid due to inadequate sealing.
PRODUCT: Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated
Humidifier. Product numbers: 425-00, 425-10 and 525-30. Recall #
Z-1040-2010.
MANUFACTURER: Recalling Firm: Telefelx Medical, Durham, NC, by letter
on/about January 12, 2010.Manufacturer: Teleflex Medical, Inc., Tecate,
B.C., Mexico. Firm initiated recall is ongoing.
REASON: When turned on, the Neptune heater may cause an artifact on the
patient's heart monitor.
The following is condensed list of medical devices involved
in recalls listed by the FDAEnforcement Report as of
March 03, 2010:
CLASS II
PRODUCT:
1) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery,
REF 70129-204, 8 x 40, Sterile EO. Intended for palliation of malignant
neoplasms in the biliary tree. Recall # Z-0801-2010;
2) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery,
REF 70129-205, 8 x 60, Sterile EO. Intended for palliation of malignant
neoplasms in the biliary tree. Recall # Z-0802-2010;
3) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery,
REF 70129-206, 8 x 80, Sterile EO. Intended for palliation of malignant
neoplasms in the biliary tree. Recall # Z-0803-2010;
4) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery,
REF 70129-208, 10 x 40, Sterile EO. Intended for palliation of malignant
neoplasms in the biliary tree. Recall # Z-0804-2010;
5) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery,
REF 70129-209, 10 x 60, Sterile EO. Intended for palliation of malignant
neoplasms in the biliary tree. Recall # Z-0805-2010;
6) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery,
REF 70129-210, 10 x 80, Sterile EO. Intended for palliation of malignant
neoplasms in the biliary tree. Recall # Z-0806-2010
MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by
telephone and letter beginning January 28, 2010. Firm initiated recall
is ongoing.
REASON: Degradation of the outer portion of the delivery catheter may
prevent proper deployment of the biliary stent.
PRODUCT:
1) LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck
Valve, 3 Prepierced Y-Sites, 106 inch, Non-DEHP, 15 drops/mL; an Rx
sterile single use fluid path way for administration of I.V. fluids
using the Symbiq infusion pump; 48 sets per case; list number 16096-28.
List Number: 16096-28. Recall # Z-0808-2010;
2) LifeShield Latex-free Primary I.V. Set, convertible P.P. yellow key
slide clamp, backcheck valve, 4 Clave ports, piggyback with Option-Loc,
attached extension set, 122 inch, 15 drops/mL; an Rx sterile single use
fluid path way for administration of I.V. fluids; 48 sets per case; list
number 19689-01; List Number: 19689-01. Recall # Z-0809-2010
MANUFACTURER: Recalling Firm: Hospira Inc., Lake Forest, IL, by letter
dated January 8, 2010. Manufacturer: Hospira Holdings de, Costa Rica
Ltd., La Aurora de Heredia, Costa Rica. Firm initiated recall is
ongoing.
REASON: There is a potential for fluid to leak from the backcheck valve
which could result in inaccurate delivery and occupational exposure.
PRODUCT: Locator Restorative Abutment, ILOA002, Certain Locator
Abutment, 4.1 mm(D) X 2mm(H), Sterile. For use on tissue supported
removable over-dentures on 2 to 4 implants, partially edentulous
overdentures with one or more implants, limited interarch distance,
angle correction with up to 40 degrees between divergent implants.
Recall # Z-0810-2010
MANUFACTURER:Biomet 3i, LLC, Palm Beach Gardens, FL, by telephone and
faxed letter dated November 23, 2009. Firm initiated recall is ongoing.
REASON:Package labeled as sterile may have an incomplete or partial seal
thereby possibly compromising sterility.
PRODUCT:Biphasic LIFEPAK 12 defibrillator / monitor. Part Number: LP12,
VLP12-02-(various dash numbers). Recall # Z-0811-2010
MANUFACTURER:Physio Control, Inc., Redmond, WA, by letter dated March
2009. Firm initiated recall is ongoing.
REASON: Affected devices contain a Biphasic PCBA that may have a solder
defect on the H Bridge component that could prevent the device from
providing a defibrillation shock. There could be a delay in therapy or
prevention of defibrillation therapy if the defibrillator were needed in
a cardiac arrest situation. Delay or prevention of defibrillation
therapy may contribute to the death of a viable patient.
PRODUCT: CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF
7900001 Veridex LLC, a Johnson & Johnson Company. Recall # Z-0819-2010
MANUFACTURER: Veridex, LLC, Raritan, NJ, by letters on August 12, 2009.
Firm initiated recall is ongoing.
REASON: Veridex has received 4 complaints regarding reagent bottles
having been incorrectly placed or duplicate bottles places within the
reagent tray of CellSearch Circulating Tumor Cell Kit.
PRODUCT: Encore Medical Foundation Knee Revision Baseplate, Part Number
321-01-106, Size 6, Left. Recall # Z-0826-2010
MANUFACTURER: Encore Medical, Lp, by letter on December 11, 2009. Firm
initiated recall is ongoing.
REASON: Partial lot of product was not manufactured to specification.
Central locking screw was missing threads. There is a potential for
dissociation because the screw is not able to be used as a secondary
fixation method.
PRODUCT: 1) RambaChrom KPC M/N 11500. Recall # Z-0827-2010;
2) RambaChrom VRE M/N 11600. Recall # Z-0828-2010
MANUFACTURER: Gibson Laboratories Inc., Lexington KY, by letters on
December 10, 2009. Firm initiated recall is ongoing.
REASON: Discrepancies between the product package label and technical
insert are conflicting and may be misleading to user. The technical
insert included the statement for In Vitro Diagnostic Use. The product
insert should have indicated for Research Use Only instead of for In
Vitro Diagnostic Use.
PRODUCT:1) Cybernet Medical MedStar Telemedicine System; Model 533-210.
The device is for a remote medical data collection device for the
monitoring of patients by healthcare providers. It is intended to work
with a weight scale, spirometer, blood pressure unit and pulse oximeter
and to transmit data over a phone line. Recall # Z-0852-2010;
2) Cybernet Medical MedStar Telemedicine System; Model 533-380. The
device is for a remote medical data collection device for the monitoring
of patients by healthcare providers. It is intended to work with a
weight scale, spirometer, blood pressure unit and pulse oximeter and to
transmit data over a phone line. Recall # Z-0853-2010;
3) Cybernet Medical MedStar Telemedicine System; Model 533-386. The
device is for a remote medical data collection device for the monitoring
of patients by healthcare providers. It is intended to work with a
weight scale, spirometer, blood pressure unit and pulse oximeter and to
transmit data over a phone line. Recall # Z-0854-2010;
4) Cybernet Medical MedStar Telemedicine System; Model 533-381. The
device is for a remote medical data collection device for the monitoring
of patients by healthcare providers. It is intended to work with a
weight scale, spirometer, blood pressure unit and pulse oximeter and to
transmit data over a phone line. Recall # Z-0855-2010
MANUFACTURER: Cybernet Systems Corp., Ann Arbor, MI, by letter dated
October 27, 2009. Firm initiated recall is ongoing.
REASON: A software problem renders these devices incapable of capturing
lung function, oxygen saturation and pulse data collected from multiple
tests in accordance with the instructions for use.
PRODUCT: EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50
mm straight; Product Code: M002004910580. Recall # Z-0866-2010
MANUFACTURER: Maquet Cardiovascular, LLC, Wayne, NJ, by letters on
January 20, 2010. Firm initiated recall is ongoing.
REASON:Labeling mix up: Shelf Carton label for Exxcel Soft Thin Wall
Vascular Grafts, were mislabeled as Exxcel Soft Standard Wall Grafts.
Bleeding could occur if wrong product is used.
CLASS III
PRODUCT: Percutaneous Catheter Introducer Set, VNUS Medical Technologies
Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Disposable, Single
Use, Do Not Re-sterilize. For catheter exchange or placement of closed
end catheters utilizing the Desilets-Hoffman technique. Recall #
Z-0764-2010
MANUFACTURER: Argon Medical Devices, Inc., Athens, TX, by letter dated
January 6, 2010. Firm initiated recall is ongoing.
REASON: One lot of Percutaneous Catheter Introducer Set contained
incorrect size needle.
PRODUCT: 1) IDEAL MAXPAC TOTAL SYSTEM (USA), Sterile and Nonpyrogenic,
ETO or Gamma Sterilized, Medtronic Perfusion Systems, Model: TS9453R29,
TS9453R30, TS1470R1, TS1442R1, TS9800R32, TS8299R4. Recall #
Z-0868-2010;
2) ONE SOURCE PACK, Model TK2S24, EE2S048 (OUS). Recall # Z-0869-2010
MANUFACTURER: Recalling Firm: Medtronic Inc., Minneapolis, MN, by letter
dated December 14, 2009.Manufacturer: Medtronic Cardiovascular
Revascularization & Surgical Therap, Brooklyn Park, MN. Firm initiated
recall is ongoing.
REASON: Medtronic has identified a small number of Autotransfusion One
Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates
(UBD) on the outer kit package label. The UBD on the outer label of the
kit/pack does not accurately reflect the UBD of the components within
the kit/Pack. For affected product, the outer label lists a date which
may be later than the USB of the components included in the kit/pack.
PRODUCT: ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog
Number R8323600, used in conjunction with: remel RapID Yeast Plus System
is a qualitative micromethod employing conventional and chromogenic
substrates for the identification of medically important yeast,
yeast-like, and related organisms isolated from human clinical
specimens. A complete listing of the organisms addressed by the RapID
Yeast Plus System is given in the RapID Yeast Plus Differential Chart.
RapID" YEAST PLUS System, Catalog No. R8311007. 4 hour identification of
yeast based on enzyme technology. Database includes over 40 taxa.
Requires Inoculation Fluid, REF R8325106. CE, 20 Panels/Kit. Recall #
Z-0870-2010
MANUFACTURER: Remel, Inc., Lenexa, KS, by letter dated October 29, 2009.
Firm initiated recall is complete.
REASON: There is an error in Version 1.0.77 of the electronic code
compendium (ERIC) software. The error is limited to the database
corresponding to the R8311007 RapID Yeast Plus System. The database
erroneously includes Candida dubliniensis as well as displays an
incorrect temperature range as an accessory test for codes with an
overlap between Candida albicans and Candida dubliniensis. When using
the RapID Yeast Plus panel, selecting "Display All Accessory Tests"
indicated Growth at 37 o C for Candida albicans vs "No Growth" for
Candida dubliniensis. The appropriate temperature range for resolving
this overlap is 42-45 o C, at which C. albicans should exhibit growth
but C. dubliniensis should not. The Instructions for Use for the RapID
Yeast Plus System have recently been revised to address the biochemical
similarities between these two species and indicates the correct methods
to help distinguish between them. A software patch has been issued to
modify the RapID Yeast Plus Database file. The patch is downloadable and
will delete all data and references related to Candida dubiniensis from
the database.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
February 24, 2010:
CLASS II
PRODUCT: 1) AC Power Cords, shipped between 06/2005 and 05/2009. These
cords were used in the following infusion pump models: Nutrimix, Q-Vue,
Q2, Q2 Plus, Ox4, PCA, PCA II, PCA 3, Lifecare PCA, Lifecare 4100, Plum
XL 3, Plum XL3M, Plum XL3D, Plum A+/ Plum A+3, and Gemstar Docking
Station devices. AC power cords Part Numbers: 826-85559-001,
826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall #
Z-0011-2010;
2) Acclaim Encore Infusion Pump, List # 12569-04-03 (veterinary), 12237
04-15, 12273-04-51; AC power cords Part Numbers: 826-85559-001,
826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall #
Z-0012-2010;
3) Flexiflo Quantum Enteral Pump, List number 50596; AC power cords Part
Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and
826-96057-003. Recall # Z-0013-2010;
4) GemStar AC Wall (Mains) adapter, 90-260 volts, universal, list #
13072-04-01; AC power cords Part Numbers: 826-85559-001, 826-85559-003,
826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0014-2010;
5) GemStar Docking Station (90-260 volts), list numbers 13075-04-01,
13075-04-03, 13075-04-05, 13075-04-07; AC power cords Part Numbers:
826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and
826-96057-003. Recall # Z-0015-2010;
6) LifeCare PCA Plus II, list #01950-04-03, 01950-04-05, 01950-04-07,
01950-04-51; AC power cords Part Numbers: 826-85559-001, 826-85559-003,
826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0016-2010;
7) LifeCare PCA 3, list #s 12384-04-01, 12384-04-03, 12384-04-05,
12384-04-07, 12384-04-09, 12384-04-51; AC power cords Part Numbers:
826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and
826-96057-003. Recall # Z-0017-2010;
8) LifeCare PCA with Hospira Mednet, list numbers 20709-04-01,
20709-04-03, 20709-04-51, 20709-04-53, 20709-04-77; AC power cords Part
Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and
826-96057-003. Recall # Z-0018-2010;
9) Nutrimix Micro Compounder, List #s 11365-04-01, 11365-04-03,
11365-04-05; AC power cords Part Numbers: 826-85559-001, 826-85559-003,
826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0019-2010;
10) Omniflow 4000 Plus, List numbers 40051-04-05, 40051-04-07,
40051-04-09, 40051-04-51; AC power cords Part Numbers: 826-85559-001,
826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall #
Z-0020-2010;
11) Plum LifeCare 5000 (Plum 1.6) with Dataport, list #s 02507-04-11,
02507-04-51; AC power cords Part Numbers: 826-85559-001, 826-85559-003,
826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0021-2010;
12) Plum A+ Infusion System (veterinary), list #s 60529-04-01,
60529-04-03, 60529-04-05; AC power cords Part Numbers: 826-85559-001,
826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall #
Z-0022-2010;
13) Plum A+3, list #s 12348-04-03, 12348-04-05, 12348-04-07,
12348-04-51; AC power cords Part Numbers: 826-85559-001, 826-85559-003,
826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0023-2010;
14) Plum A+ v.11.X, list #s 12391-04-01, 12391-04-03, 12391-04-05,
12391-04-11, 12391-04-51; AC power cords Part Numbers: 826-85559-001,
826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall #
Z-0024-2010;
15) Plum A+ v.10.3, list #s 11971-04-01, 11971-04-03, 11971-04-05,
11971-04-07, 11971-04-51; AC power cords Part Numbers: 826-85559-001,
826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall #
Z-0025-2010
16) Plum A+3 v.11.X, list #s 12618-04-01, 12918-04-03, 12618-04-05,
12618-04-51, 12618-04-07, 12618-04-53; AC power cords Part Numbers:
826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and
826-96057-003. Recall # Z-0026-2010;
17) Plum A+3 Infusion System with Hospira Mednet, list # 20678-04-01,
20678-04-03, 20678-04-51, 20678-04-77, 20678-04-81, 20678-04-05,
20678-04-53; AC power cords Part Numbers: 826-85559-001, 826-85559-003,
826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0027-2010;
18) Plum A+ Infusion System with Hospira Mednet, list #s 20679-04-01,
20679-04-03, 20679-04-05, 20679-04-51, 20679-04-77, 20679-04-79,
20679-04-81, 20792-04-01, 20792-04-03, 20792-04-05, 20792-04-51,
20792-04-53, 20792-04-77, 20792-04-79, 20792-04-81, 20792-04-83,
207929-04-87, 20792-04-55; AC power cords Part Numbers: 826-85559-001,
826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall #
Z-0028-2010;
19) Plum XL, list numbers 11555-04-01, 11555-04-03, 11555-04-05; AC
power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008,
826-85559-010, and 826-96057-003. Recall # Z-0029-1010;
20) Plum XLD, list numbers 11859-04-01, 11859-04-03, 11859-04-05,
11859-04-07, 11859-04-09, 11859-04-11, 11859-04-13, 11859-04-51,
12570-04-01 (veterinary). AC power cords Part Numbers: 826-85559-001,
826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall #
Z-0030-2010;
21) Plum XL 3, list #s 11781-04-01, 11781-04-03, 11781-04-05. AC power
cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008,
826-85559-010, and 826-96057-003. Recall # Z-0031-2010;
22) Plum XL3M, List numbers 11845-04-03, 11845-04-05, 11845-04-07,
11845-04-11, and 11845-04-13. AC power cords Part Numbers:
826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and
826-96057-003. Recall # Z-0032-2010;
23) Plum XLM, list #s 11846-04-03, 11846-04-05, 11846-04-07. AC power
cords Part Numbers: 826-85559-001, 826-85559- 003, 826-85559-008,
826-85559-010, and 826-96057-003. Recall # Z-0033-2010;
24) Plum XL3D, list #s 11855-04-01, 11855-04-03, 11855-04-05,
11855-04-07; AC power cords Part Numbers: 826-85559-001, 826-85559-003,
826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0034-2010
MANUFACTURER: Hospira, Inc., Morgan Hill, CA, by press release and
letter on August 14, 2009. Firm initiated recall is ongoing.
REASON: Fire/Shock hazard – A component used in the device may cause
sparks/flashes and poses a fire and shock hazard.
PRODUCT: Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc.
Use: feet tanner. Recall # Z-0608-2010
MANUFACTURER: Solafeet, Inc., Sarasota, FL, by letters September 8,
2009. Firm initiated recall is ongoing.
REASON: Product failed to have a label that contained a recommended
exposure schedule; the operator's manual provided inadequate
instructions for use; and label implication may result in overexposure.
PRODUCT:
1) University Health System Custom Cardiac Cath Pack, K09T-02178,
Srterile EO. Intended for fluid management convenience when
catheterization is required. Recall # Z-0744-2010;
2) Custom Cardiac Cath Pack Kit, K09-08945, Sterile EO. Intended for
fluid management convenience when catheterization is required. Recall #
Z-0745-2010;
3) Custom Angiographic Kit, K09-MS3084, Sterile EO. Intended for fluid
management convenience. Recall # Z-0746-2010;
4) Jeanes Hospital Custom Cath Procedure Tray, K09T-08945, Sterile EO.
Intended for fluid management convenience when catheterization is
required. Recall # Z-0747-2010;
5) Jeanes Hospital Custom Cath Procedure Tray, K09T-08945A, Sterile EO.
Intended for fluid management convenience when catheterization is
required. Recall # Z-0748-2010
MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by
telephone and letter beginning January 29, 2009. Firm initiated recall
is ongoing.
REASON: A manufacturing defect may prevent adequate sterilization of the
entire device.
PRODUCT: RX ACCULINK Carotid Stent System, 10x40 mm, Product Number:
1011344-40. Indicated for the treatment of patients at high risk for
adverse events from carotid endarterectomy who require carotid
revascularization. Recall # Z-0749-2010
MANUFACTURER: Abbott Vascular-Cardiac Therapies dba Guidant Corp.,
Temecula, CA, by letter beginning October 1, 2009. Firm initiated recall
is ongoing.
REASON: The affected lot may not meet our quality specifications for
catheter shaft tensile strength.
PRODUCT:
1) Triathlon Total Stabilizer Femoral Component; Size # 2 for Use with
TS Components; Sterile. The Triathlon Total Knee System components are
intended for use in primary and revision total knee arthroplasty to
alleviate pain and restore function. Catalog number: 5512-F-201. Recall
# Z-0757-2010;
2) Triathlon Total Stabilizer Femoral Component; For Use with TS
Components; Sterile. The Triathlon Total Knee System components are
intended for use in primary and revision total knee arthroplasty to
alleviate pain and restore function. Catalog number: 5512-F-301. Recall
# Z-0758-2010;
3) Triathlon Total Stabilizer Femoral Component; For Use with TS
Components; Sterile. The Triathlon Total Knee System components are
intended for use in primary and revision total knee arthroplasty to
alleviate pain and restore function. Catalog number: 5512-F-402. Recall
# Z-0759-2010;
4) Triathlon Total Stabilizer Femoral Component; For Use with TS
Components; Sterile. The Triathlon Total Knee System components are
intended for use in primary and revision total knee arthroplasty to
alleviate pain and restore function. Catalog number: 5512-F-501. Recall
# Z-0760-2010;
5) Triathlon Total Stabilizer Femoral Component; For Use with TS
Components; Sterile. The Triathlon Total Knee System components are
intended for use in primary and revision total knee arthroplasty to
alleviate pain and restore function. Catalog number: 5512-F-502. Recall
# Z-0761-2010
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter
dated December 10, 2009. Firm initiated recall is ongoing.
REASON: Triathlon TS femoral components may have been damaged during
manufacturing, possibly preventing the assembly of a stem extension.
PRODUCT: MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic
Resonance Imaging system intended for use with clinical/radiologic
diagnostic imaging applications. Recall # Z-0780-2010
MANUFACTURER: Philips Medical Systems (Cleveland), Inc., Cleveland, OH,
by letter dated December 4, 2009 and visit. Firm initiated recall is
ongoing.
REASON: Polymeric RF connector block on the tabletop overheated and
eventually ignited during scanning due to combination of arcing of
electrical components associated with the RF trap assembly located below
the connector and flame rating of the connector block material.
PRODUCT:
1) Stryker Xia Precision System; Jam Shidi 10 Gauge 9 inch; Sterile.
Intended for use as a manual surgical instrument during percutaneous
posterior, non-cervical pedicle fixation. Catalog number: 48237110.
Recall # Z-0789-2010;
2) Stryker Xia Precision System; Jam Shidi 10 Gauge 5 inch; Sterile.
Intended for use as a manual surgical instrument during percutaneous
posterior, non-cervical pedicle fixation. Catalog number: 48237105.
Recall # Z-0790-2010;
3) Stryker Xia Precision System; Jam Shidi 11 Gauge 5 inch; Sterile.
Intended for use as a manual surgical instrument during percutaneous
posterior, non-cervical pedicle fixation. Catalog Number: 48237115.
Recall # Z-0791-2010;
4) Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile.
Intended for use as a manual surgical instrument during percutaneous
posterior, non-cervical pedicle fixation. Catalog number: 48237135.
Recall # Z-0792-2010
MANUFACTURER: Recalling Firm: Stryker Spine, Allendale, NJ, by letter
dated January 15, 2010. Manufacturer: Angiotech Manan Medical, Wheeling,
IL. Firm initiated recall is ongoing.
REASON: Stryker Spine received reports of packaging failures during
shipping for the Jam Shidi instruments, which may compromise the
sterility of the product.
PRODUCT:
1) Reamer T-Handle; Non- Sterile. Intended for use in orthopedic surgery
to interface with various cutting instruments and drivers. Catalog
Number: 1101-2100. Recall # Z-0793-2010;
2) Navigation Reamer T-handle; Non Sterile. Intended for use in
orthopedic surgery to interface with various cutting instruments and
drivers. Catalog Number: 2124-2100. Recall # Z-0794-2010
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter
dated August 8, 2005. Firm initiated recall is complete.
REASON: Stryker Orthopedics learned that the T-handles have the
potential to not engage and not attach to the reamer properly.
PRODUCT: Scorpio PS Femoral Waffle (No post) and LFIT; Use only with
Scorpio PS Tibial Bearing inserts and Scorpio Patellas, Stryker
Orthopaedics. Intended for cemented application to replace the
articulating surface of the distal femur. Scorpio (no post) with LFIT:
Product code 72-4107-L. Recall # Z-0795-2010
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter
dated July 7, 2007. Firm initiated recall is complete.
REASON: Stryker Orthopaedics became aware that a box packaged and
labeled as a Scorpio PS Femoral Waffle (No Post) with LFIT, may actually
contain a Scorpio Femoral Waffle (With Post) and LFIT.
PRODUCT: Depth Gauge; Catalog Number: 703707. This product is sold
separately or as part of Kit # 990256. The depth gauge is an instrument
in the VariAx Elbow System. Depth gauges are tools used
intra-operatively, to aid in correct screw selection. They can be used
with a plate, or directly on bone. Recall # Z-0796-2010
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah,
NJ, by letter dated December 22, 2009. Manufacturer: Stryker Trauma AG,
Selzach, Switzerland. Firm initiated recall is ongoing.
REASON: The Depth Measuring Gauges have 5 scale marking instead of the
required 4 scale markings.
PRODUCT: 2-Channel Laryngeal Surface Electrode (Model LSE500DCS and
LSE500DCL) For use as a Surgical stimulator/locator for recurrent
laryngeal nerve. Recall # Z-0798-2010
MANUFACTURER: Recalling Firm: Neurovision Medical Products Inc, Ventura,
CA, by letter dated January 7, 2010. Manufacturer: R & D Medical
Products Inc., Lake Forest, CA. Firm initiated recall is ongoing.
REASON: This recall has been initiated due to conductive glue used to
attach the lead wire to electrode, which has been found in a small
number of electrodes, to cause a short circuit in one of the channels.
This is due to migration of the adhesive from one pad to the other
creating an electrical short. Use of one of these defective electrodes
could lead to a failure to monitor. Our investigation has concluded that
the existing defect has a small likelihood of putting a patient at risk
due to (1) the ease in identifying any defective product prior to use
and (2) that any short circuit will be apparent to a licensed IOM
clinician when plugged into a monitor. We have received calls from two
of our customers with this complaint.
CLASS II
PRODUCT: 1) V6400 Invasive Pressure Monitor uses WW3005 power cord.
Electri-Cord. Recall # V-033-2010; 2) V9200 Advisor Vital Signs Monitor
utilizes the power cord WW3005. Recall # V-034-2010; 3) V8400 Capnocheck
Capnometer utilizes the power cord 8404 for its battery charger. Recall
# V-035-2010
MANUFACTURER: Smiths Medical PM, Inc., Waukesha, WI, by letter dated
January 12, 2010. Firm initiated recall is ongoing.
REASON: Smiths Medical is conducting a voluntary recall of a limited
number of medical device AC power cords, for use with BCI 3180 Pulse
Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or Veterinary),
8400 Capnocheck II Capnometer(Human or Veterinary) and V6400 Invasive
Pressure Monitor (Veterinary). The affected Electri-Cord AC power cords
are equipped with a plug that has prong and ground-pin insert design and
a black plastic bridge connecting the terminal prongs on the plug. The
FDA has reported that two medical device manufactures have reported
incidents of sparking, charring, and fires from the affected power cords
used with their devices. Smiths medical has received no reports of
incidents regarding the use of the affected Electric-Cord power cords
with their devices.
Please visit our websites at www.mdiconsultants.com for more information
on mdi’s services, staff and items of interest.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
February 17, 2010
CLASS I
PRODUCT:
1) EndoClamp aortic catheter. Label reading in part: "***CARDIOVATIONS
EndoClamp aortic catheter 100 cm, REF EC1001. The device is a 10.5Fr
wirewound, three-lumen catheter with a balloon near its tip for
occluding the ascending aorta. Indicated for use in patients undergoing
cardiopulmonary bypass surgery. The catheter occludes the ascending
aorta, vents the aortic root and allows delivery of cardioplegia
solution to arrest the heart. The pressure lumen allows monitoring of
the aortic root pressure. Recall # Z-0084-2010;
2) EndoClamp aortic catheter label reading in part: "CARDIOVATIONS
EndoClamp aortic catheter 65 cm,STERILE R, REF EC65. The device is a
10.5Fr wirewound, three-lumen catheter with a balloon near its tip for
occluding the ascending aorta. Indicated for use in patients undergoing
cardiopulmonary bypass surgery. The catheter occludes the ascending
aorta, vents the aortic root and allows delivery of cardioplegia
solution to arrest the heart. The pressure lumen allows monitoring of
the aortic root pressure. Recall # Z-0085-2010.
MANUFACTURER: Recalling Firm: Edwards Lifesciences Research Medical,
Inc. Midvale, UT, by letter, dated September 29, 2009. Manufacturer:
Accellent, Inc., Laconia, NH. Firm initiated recall is ongoing.
REASON: Spontaneous balloon rupture during use of the product.
PRODUCT: Pointe Scientific Liquid Glucose (HEXO) Reagent Set; Catalog
#'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120,
8-G7517-500, 3-G7517-L, 7-G7517-500 and 7-G7517-1000. (Clinical
chemistry) Pointe Scientific Liquid Glucose (HEXO) is used for the
quantitative determination of glucose in serum. Recall # Z-0104-2010.
MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by press release on
October 30, 2009 and by letters on October 19, 2009 and November 2,
2009. Firm initiated recall is ongoing.
REASON: There is a loss of linearity. The product fails to maintain
linearity specification of 500 mg/dL.
PRODUCT:
1) Synthes USA, TI Synex (TM) II Central Body 14mm - 19mm, Catalog
number 04.808.001. Intended for use in the thoracolumbar spine (T1-L5)
to replace a collapsed, damaged, or unstable vertebral body due to tumor
or trauma. To be used with Synthes supplemental internal fixation
system. Recall # Z-0108-2010;
2) Synthes USA, TI Synex (TM) II Central Body 17mm - 25mm, Catalog
number 04.808.002. Intended for use in the thoracolumbar spine (T1-L5)
to replace a collapsed, damaged, or unstable vertebral body due to tumor
or trauma. To be used with Synthes supplemental internal fixation
system. Recall # Z-0109-2010;
3) Synthes USA, TI Synex (TM) II Central Body 21mm - 29mm, Catalog
number 04.808.003. Intended for use in the thoracolumbar spine (T1-L5)
to replace a collapsed, damaged, or unstable vertebral body due to tumor
or trauma. To be used with Synthes supplemental internal fixation
system. Recall # Z-0110-2010;
4) Synthes USA, TI Synex (TM) II Central Body 25mm - 33mm, Catalog
number 04.808.004. Intended for use in the thoracolumbar spine (T1-L5)
to replace a collapsed, damaged, or unstable vertebral body due to tumor
or trauma. To be used with Synthes supplemental internal fixation
system. Recall # Z-0111-2010;
5) Synthes USA, TI Synex (TM) II Central Body 29mm - 44mm, Catalog
number 04.808.005. Intended for use in the thoracolumbar spine (T1-L5)
to replace a collapsed, damaged, or unstable vertebral body due to tumor
or trauma. To be used with Synthes supplemental internal fixation
system. Recall # Z-0112-2010;
6) Synthes USA, TI Synex (TM) II Central Body 37mm - 52mm, Catalog
number 04.808.006. Intended for use in the thoracolumbar spine (T1-L5)
to replace a collapsed, damaged, or unstable vertebral body due to tumor
or trauma. To be used with Synthes supplemental internal fixation
system. Recall # Z-0113-2010;
7) Synthes USA, TI Synex (TM) II Central Body 45mm - 71mm, Catalog
number 04.808.007. Intended for use in the thoracolumbar spine (T1-L5)
to replace a collapsed, damaged, or unstable vertebral body due to tumor
or trauma. To be used with Synthes supplemental internal fixation
system. Recall # Z-0114-2010;
8) Synthes USA, TI Synex (TM) II Central Body 58mm - 84mm, Catalog
number 04.808.008. Intended for use in the thoracolumbar spine (T1-L5)
to replace a collapsed, damaged, or unstable vertebral body due to tumor
or trauma. To be used with Synthes supplemental internal fixation
system. Recall # Z-0115-2010;
9) Synthes USA, TI Synex (TM) II Central Body 71mm - 97mm, Catalog
number 04.808.009. Intended for use in the thoracolumbar spine (T1-L5)
to replace a collapsed, damaged, or unstable vertebral body due to tumor
or trauma. To be used with Synthes supplemental internal fixation
system. Recall # Z-0116-2010;
10) Synthes USA, TI Synex (TM) II Central Body 84mm - 110mm, Catalog
number 04.808.010. Intended for use in the thoracolumbar spine (T1-L5)
to replace a collapsed, damaged, or unstable vertebral body due to tumor
or trauma. To be used with Synthes supplemental internal fixation
system. Recall # Z-0117-2010;
11) Synthes USA, TI Synex (TM) II Central Body 97mm - 123mm, Catalog
number 04.808.011. Intended for use in the thoracolumbar spine (T1-L5)
to replace a collapsed, damaged, or unstable vertebral body due to tumor
or trauma. To be used with Synthes supplemental internal fixation
system. Recall # Z-0118-2010.
MANUFACTURER: Recalling Firm: Synthes USA (HQ), Inc., West Chester, PA,
by letter dated September 23, 2009. Manufacturer: Synthes GMBH, Oberdorf,
Switzerland. Firm initiated recall is ongoing.
REASON: Loss of device height.
PRODUCT:
1) Stryker Instruments Navigation System II- CART; Stryker REF
7700-100-000. Intended to be used as a component of the Navigation
System II. Recall # Z-0122-2010;
2) Stryker Instruments Navigation System II PC SPC-1 Assembly; REF
7700-101-201. The Stryker Navigation System II is a computer-aided
surgery platform, supporting surgeons to perform surgical interventions.
Recall # Z-0123-2010.
MANUFACTURER: Recalling Firm: Stryker Instruments Div. of Stryker Corp.,
Kalamazoo, MI, by letter dated October 23, 2009 and Press release on
November 3, 2009. Manufacturer: Stryker Leibinger GMBH & CO. KG –
Navigation, Freiburg Im Breisgau, Germany. Firm initiated recall is
ongoing.
REASON: Multiple software-related malfunctions may occur. The device may
suddenly stop working, the screen may freeze, the screen may only be
updated very slowly, the unit may not respond to user input, or the unit
may only respond to user very slowly.
PRODUCT: Thomas Medical Products Safesheath CSG (Coronary Sinus Guide)
Hemostatic Tear away Introducer System with Infusion Side Port, for the
introduction of various types of pacing or defibrillator leads and
catheters. The product is shipped 5 per carton. Catalog numbers:
CSG/MSP-00-09, CSG/90-09, CSG-KR-90-09, CSG/WORLEY-1-09,
CSG-WORLEY-Bcor-1-09, CSG/WORLEY/L/Bcor-1-09, CSG/WORLEY-2-09,
CSG/WORLEY/Bcor-2-09, CSGMSP0009M, CSGWORLEY109M, CSGWORL19M,
CSGWORBC19M, CSGWORLBC19M, CSGWORBC29M, CSG/Worley/BCor-1-07,
CSG/Worley/BCor-2-07, CSG/WORLEY/BCOR-M-09, and CSG/Worley/R-1-09.
Recall # Z-0661-2010.
MANUFACTURER: Thomas Medical Products, Inc., Malvern, PA, by e-mail on
December 23, 2009 and by press release on January 29, 2010. Firm
initiated recall is ongoing.
REASON: Radiopaque sheath tip may fracture.
PRODUCT:
1) BD Q-Syte, Luer Access Split-Septum, 0.10 ml, Sterile EO, REF 385100.
Recall # Z-0750-2010;
2) BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok,
Sterile EO, Assembled in Mexico, REF 385101. Recall # Z-0751-2010;
3) BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, Sterile EO, REF 385102.
Recall # Z-0752-2010;
4) BD Q-Syte Vial Access Adapter, 0.16 ml, Sterile EO, REF 385108.
Recall # Z-0753-2010;
5) MPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte,
Sterile EO, REF 385150. Recall # Z-0754-2010;
6) MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte,
Sterile EO, REF 385151. Recall # Z-0755-2010;
7) MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte,
Sterile EO, REF 385164. Recall # Z-0756-2010
MANUFACTURER: Becton Dickinson Medical Systems, Sandy, UT, by letter on
October 28, 2009. Firm initiated recall is ongoing.
REASON: Manufacturing defect may allow air entry into a central venous
catheter, possibly resulting in an air embolism.
CLASS II
PRODUCT: Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F.
The product is intended for use in Temporary Vessel Occlusion. Recall #
Z-0002-2010.
MANUFACTURER: Recalling Firm: Edwards Lifesciences, LLC, Irvine, CA, by
letter dated June 29, 2009. Manufacturer: Edwards Lifesciences
Technology SARL, Anasco, PR. Firm initiated recall is ongoing.
REASON: Several complaints were the two parts of the tubular package
became loose under the shrink wrap that holds the DFU on the packaging
tube.
PRODUCT: HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The
HeartStart MRx/MRxE is for use for the termination of ventricular
tachycardia and ventricular fibrillation. The device is for use by
qualified medical personnel trained in the operation of the device and
qualified by training basic life support, advanced cardiac support, or
defibrillation. It must be used by or on the order of a physician.
Recall # Z-0003-2010.
MANUFACTURER: Philps Healthcare, Inc., Andover, MA, by letter on August
21, 2009. Firm initiated recall is ongoing.
REASON: Incorrect default configuration settings, insufficient battery
power as the user may not be alerted that no battery is installed or
that a low battery condition exists prior to disconnecting from AC or DC
power.
PRODUCT: Boston Scientific Liberte Monorail and Over-the-Wire Coronary
Stent Systems to be relabeled as VeriFLEX". The Liberte Coronary Stent
System consists of a balloon expandable stainless steel stent,
pre-mounted on either a Liberte Monorail (MR) or Liberte Over-the-Wire
(OTW) delivery system. The Liberte system comes in stent diameters of
2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50 and 5.00 mm and stent lengths
of 8, 12, 16, 20, 24, 28 and 32 mm. The stent is mounted on the balloon
between two radiopaque markers which, in conjunction with fluoroscopy,
aid in the placement of the systems balloon segment and stent. The
balloon enables high pressure inflations and can be used for post-stent
dilatation. Recall # Z-0068-2010.
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Maple Grove, MN,
by letter dated September 18, 2009. Manufacturer: Boston Scientific
Ireland, Ltd., Galway, Ireland. Firm initiated recall is ongoing.
REASON: Boston Scientific initiated a field correction for the Liberte
Bare-Metal coronary stent products. They have received reports from
cardiac cath labs that TAXUS Liberte Paclitaxel-Eluting (TAXUS Libert
Drug-Eluting) coronary stents have been inadvertently selected when the
interventional cardiologist intended to implant a Liberte Bare-Metal
stent, and Libert Bare-Metal stents have been inadvertently selected
when the interventional cardiologist intended to implant a TAXUS Libert
Drug-Eluting stent. Selecting the wrong device may present a risk of
serious injury, including death. Because of the importance of accurate
device selection to patient safety, Boston Scientific are renaming the
Liberte Bare-Metal stent. The new name is VeriFlex" Bare-Metal.
Representatives from Boston Scientific will be visiting all impacted
health care facilities to re-label the outer boxes of all existing
Libert Bare-Metal stents held in inventory, to reflect the new name.
PRODUCT:
1) SYNTHES 2.0MM SCREW MANIPULATION FORCEPS, Catalog #SD397.300. Synthes
Titanium Matrix Mandible Sagittal Plates and Instruments are intended
for general use in orthographic surgery. Recall # Z-0075-2010;
2) SYNTHES BENDING PLIERS - STRAIGHT FOR CRANIOFACIAL/ORTHOGNATHIC PL,
Catalog # SD347.967. Synthes Titanium Matrix Mandible Sagittal Plates
and Instruments are intended for general use in orthographic surgery.
Recall # Z-0076-2010;
3) SYNTHES PLATE HOLDING FORCEPS, Catalog # SD347.900. Recall #
Z-0077-2010;
4) SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/39MM,
Catalog # SD448.003. Synthes Titanium Matrix Mandible Sagittal Plates
and Instruments are intended for general use in orthographic surgery.
Recall # Z-0078-2010;
5) SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/42MM,
Catalog # SD448.004. Synthes Titanium Matrix Mandible Sagittal Plates
and Instruments are intended for general use in orthographic surgery.
Recall # Z-0079-2010;
6) SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/45MM,
Catalog # SD448.005. Synthes Titanium Matrix Mandible Sagittal Plates
and Instruments are intended for general use in orthographic surgery.
Recall # Z-0080-2010;
7) SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/48MM,
Catalog # SD448.006. Synthes Titanium Matrix Mandible Sagittal Plates
and Instruments are intended for general use in orthographic surgery.
Recall # Z-0081-2010;
8) SYNTHES 2.0MM DRILL BIT STRYKER J-LATCH/60MM, Catalog # 317.853.
Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are
intended for general use in orthographic surgery. Recall # Z-0082-2010.
MANUFACTURER: Synthes USA, West Chester, PA, by letter on September 4,
2009. Firm initiated recall is ongoing.
REASON: The customized plate instruments do not have a cleared premarket
notification.
PRODUCT: Siemens ARTISTE syngo RT Therapist, model/part #8162815; syngo
RT Therapist Assist, model/part #8162807; Therapist Express Basic,
model/part #8151289 and Therapist Express Assist Systems model/part
#8151289. Recall # Z-0121-2010.
MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by
letter, dated September 10. 2009. Firm initiated recall is ongoing.
REASON: A failed data transfer is possible that may result in data not
being recorded in the interfaced system.
PRODUCT: ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and
wash zone mechanism grounding kit. ARCHITECT System is designed to
perform automated chemistry tests utilizing photometry and
potentiometric technology; and immunoassay tests utilizing
chemiluminescent microparticle assay detection technology. Wash Zone
Mechanism Grounding Kit Part Number 7-201369-01; Concentrated Wash
Buffer 1 L and l0 L. Recall # Z-0132-2010.
MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on July
17, 2009. Firm initiated recall is ongoing.
REASON: Under certain conditions, the product's wash buffer containing
sodium azide can come in contact with the wash zone mechanism ground
cables on either of the two wash zones. The copper in the ground strap
may corrode and form an unstable chemical substance (metal azide) that
may be sensitive to direct pressure and impact.
PRODUCT: Stryker Imaging, Guardian Services Software, Part Number
0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office
PACS Power). Intended use is to act as a medical data backup and
disaster recovery plan. Recall # Z-0134-2010.
MANUFACTURER: Stryker Imaging, Flower Mound, TX, by letter dated August
18, 2009. Firm initiated recall is ongoing.
REASON: Firm has determined Guardian Services does not contain 100% data
backup for 12 OfficePACS Power customers on a daily basis.
PRODUCT: Olsen Medical, Midas Touch Needle Electrode, with Modified
Tip. Model Numbers: a) 30-1011, b) 30-1012, c) 30-1013, d) 30-1014 and
e) 30-6011. Recall # Z-0140-2010.
MANUFACTURER: Kentucky Packaging Service LP, Louisville, KY, by letter
beginning September 24, 2009. Firm initiated recall is ongoing
REASON: There were inconsistencies noticed on the insulation overlap.
The electrode has a large diameter shaft that transitions to a smaller
diameter shaft. The 1st layer of insulation which covers the small
diameter shaft overlaps with the 2nd layer of insulation that covers the
larger diameter shaft. On some electrodes it appears that the overlap is
too short to cover the transition which makes this area vulnerable to
insulation damage
PRODUCT: ABL 80 CO-OX System, software versions 1.30 and 1.31 Additional
Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The
ABL 80 CO-OX System is a portable, automated analyzer that measures pH,
blood gases, electrolytes, glucose and oximetry in whole blood. The ABL
80 CO-OX System is intended for use by trained technologists, nurses,
physicians and therapists. It is intended for use in a laboratory
environment, near patient or point-of-care setting. Recall #
Z-0150-2010.
MANUFACTURER: Sendx Medical Inc., Carlsbad, CA, by letter September 20,
2009. Firm initiated recall is ongoing.
REASON: A potential error contained in V1.30 and V1.31 software for the
ABL 80 CO-OX platform. The error can occur if the analyzer is set to
automatically upload patient records to Radiance or an HIS/LIS system.
This can result in the reporting of incorrect results for one or more
CO-OX derived parameters. Incorrect results can be displayed on the
screen and the sample printout. All measured values will report
correctly, only the CO-OX derived parameters listed below are at risk of
being reported incorrectly: HCT p50 p50(T) p50(st) pO2 (a)/FO2(I)
pO2(a,T)/FO2(I) pO2 pO2(x,T) BO2 DO2 Qt VO2 FShunt FShunt (T) Q V(B)
ctO2.
PRODUCT: Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog
number BFR-6CTT 5 per box. Hemodialysis catheter insertion kits. Recall
# Z-0161-2010.
MANUFACTURER: Medical Components, Inc dba MedComp., Harleysville, PA,
letter dated September 2, 2009. Firm initiated recall is ongoing.
REASON: Mislabeled as right are actually left.
PRODUCT: Byrd Screw, 2.0X6MM SD, Model Number: 01-0264 Product labeling
reads in part as follows: REF: 01-0264, QTY,UOM 00001, BYRD SCREW, 2
OX6MM SELF-DRILLING, 12CM, (4-3/4) (L), STAINLESS STEEL, LOT 999999,
(01) 00841036007157(10)999999(13)090201(30)13, 2009-02, ***NON-STERILE
PRODUCT***DD 14 03 1. Instrument used to pull up the broken bone, so it
is flush and can be plated fixated. The Byrd screw is then removed.
Recall # Z-0169-2010.
MANUFACTURER: Biomet Microfixation, Inc., Jacksonville, FL, by letters
on February 19, 2009. Firm initiated recall is ongoing.
REASON: Byrd Screw, Self Drilling, may break during usage. BIOMET has
determined that the parts were not correctly processed by the vendor,
i.e. that the parts were not hardened in the final processing and that
lead to weaker than acceptable material.
PRODUCT:
1) HANAULUX 2004 IXL cupola, P/N: 56076868. Intended to provide visible
illumination for the surgical field or for the examination of the
patient. Recall # Z-0182-2010;
2) HANAULUX 2005 I cupola, P/N: 56076865. Intended to provide visible
illumination for the surgical field or for the examination of the
patient. Recall # Z-0183-2010;
3) HANAULUX 2005 IXL cupola, P/N: 56076869. Intended to provide visible
illumination for the surgical field or for the examination of the
patient. Recall # Z-0184-2010;
4) HANAULUX 2004-2005 TV Spring Arm, P/N: 569002998. Intended to provide
visible illumination for the surgical field or for the examination of
the patient. Recall # Z-0185-2010;
5) XTEN DF cupola, P/N: 567800999. Intended to provide visible
illumination for the surgical field or for the examination of the
patient. Recall # Z-0186-2010;
6) XTEN LED Video DF cupola, P/N: 567801999. Intended to provide visible
illumination for the surgical field or for the examination of the
patient. Recall # Z-0187-2010;
7) XTEN LED DF cupola, P/N: 567815999. Intended to provide visible
illumination for the surgical field or for the examination of the
patient. Recall # Z-0188-2010.
MANUFACTURER: Recalling Firm: Maquet, Inc., Bridgewater, NJ, by letters
dated October 7, 2009. Manufacturer: Maquet S.A., Orleans Cedex 2,
France. Firm initiated recall is ongoing.
REASON: Several reports have been received regarding one model of spring
arm (Acrobat 200 series) in combination with surgical light from various
Manufacturers. All incidents pertain to a crack on the front joint of
the Acrobat arm.
PRODUCT:
1) Revolution Blood Pump, "revOlution Centrifugal pump Catalog #
050300000***Rx ONLY. Intended for use in cardiopulmonary bypass
procedures. Recall # Z-0192-2010;
2) Revolution Blood Pump with PC Coating, "revOlution Centrifugal pump
Catalog # 050300700***Rx ONLY. Intended for use in cardiopulmonary
bypass procedures. Recall # Z-0193-2010.
MANUFACTURER: Recalling Firm: Sorin Group USA, Inc., Arvada, CO, by
letter dated September 25, 2009. Manufacturer: Sorin Group Italia SRL,
Milano, Italy. Firm initiated recall is ongoing.
REASON: A weakness in the plastic packaging tray could cause the tray to
crack; compromising product sterility.PRODUCT: STERIS Harmony LL 500/700
Surgical Light, Vertical Spring-Loaded Arm. Intended for local
illumination of the operating and examination area of the patient in
treatment rooms. Part Number: YG18568. Recall # Z-0414-2010.
MANUFACTURER: Recalling Firm: Steris Corp., Mentor OH, by letters dated
September 11, 2009. Manufacturer: Drager Medical AG & Co. KGAA, Luebeck,
Germany. Firm initiated recall is ongoing.
REASON: (4) reported international cases received where a welded seam at
the joint of the spring-loaded arm of the Drger SOLA 500/700 surgical
light broke as a result of a crack that had slowly developed over time.
The STERIS Harmony LL 500/700 surgical light is a Private Label version
of the Drger SOLA 500/700 surgical light.
PRODUCT:
1) Discovery CT 750 HD model numbers: 5232083, 5232083-2, 5232083-3, and
5232083-4. For head, whole body, cardiac and vascular X-ray Computed
Tomography applications. Recall # Z-0668-2010;
2) LightSpeed VCT 7.2 Vision model numbers: 5212920-300 console used
with 5129909, 5129909-5, and 5129909-11 gantry. For head, whole body,
cardiac and vascular X-ray Computed Tomography applications. Recall #
Z-0669-2010.
MANUFACTURER: GE Healthcare, Wauwatosa, WI, by letter on October 1,
2009. Firm initiated recall is ongoing.
REASON: Failure to properly document the CTDI in the Technical Reference
or User Manual.
PRODUCT: Biomet bone mulch screw, 10.5mm x 20 mm, TI-6AL-4V alloy,
sterile, REF 907320. Recall # Z-0779-2010.
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated December 22,
2009. Firm initiated recall is ongoing.
REASON: The screw may not have the hex dimension inside of the head of
the screw, which will prevent the device from being implantable. This
may cause a delay in the procedure while another screw is obtained.
PRODUCT
1) FilteredFlo Cardiac Blanket. The device is used to distribute heated
air around a patient (for patient warming). Product # 82542; Catalog #
542. Recall # Z-0781-2010;
2) TempPad Cold Therapy Pad. The device is used for localized
temperature therapy including hand, elbow, arm, foot, ankle, leg, or
knee. a) Part #: 50625, Catalog number: 510-US; b) Part #: 50633,
Catalog #: 510-USS; c) Part #: 50627, Catalog #: 814-US; d) Part #
50634, Catalog # 814-USS; e) Part #: 50628, Catalog #: 1112-US; f) Part
#:50635, Catalog #: 1112-USS; g) Part #: 50629, Catalog #: 1215-US; h)
Part #: 50137, and Catalog #: CT-99. Recall # Z-0782-2010
MANUFACTURER: Cincinnati Sub-Zero Products, Inc., Cincinnati, OH, by
letters on November 14, 2009 and December 10, 2009. Firm initiated
recall is ongoing.
REASON: Product is labeled as "Sterile" During the production process it
was observed that the sterilizer equipment was creating incomplete seals
in the packaging materials. When the seal is compromised, the sterility
of the product inside the package cannot be assured.
There will be no Enforcement Report for
February 10, 2010
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
February 3, 2010:
CLASS I
PRODUCT:
1) Centurion Healthcare Products Preemie Packs, 50, sterile; code no.
LM110. Aspiration tray containing Portex uncuffed pediatric sized
tracheal tubes. Recall # Z-0105-2010;
2) Centurion Healthcare Products, Full Term Meconium Packs, 50, sterile;
code no. LM115. Recall # Z-0106-2010.
MANUFACTURER: Recalling Firm: Centurion Medical Products, Howell, MI, by
e-mail on September 22, 2009 and by letter dated September 23, 2009.
Manufacturers: Centurion Medical Products, Howell, MI, and Smiths
Medical, Hythe, Kent, United Kingdom. Firm initiated recall is complete.
REASON: The manufacturer of the pediatric tracheal tubes used in these
kits recalled them because they were manufactured with an internal
diameter smaller than indicated in the label, which could result in an
inability to remove secretions and cause partial or complete obstruction
of the airway.
PRODUCT:
1) Mikro 12-24 Centrifuge with 2050 Rotor TYP #2070 and TYP 2070-01.
Used for the purpose of determining the hematocrit count of a patient
sample by way of applying centrifugal force in a manner that separates
red blood cells and allows the proportion of red cell mass to plasma to
be measured. Recall Z-0612-2010;
2) Haematokrit 24 Centrifuge with 2050 Rotor TYP #2075 and TYP #2075-01.
Used for the purpose of determining the hematocrit count of a patient
sample by way of applying centrifugal force in a manner that separates
red blood cells and allows the proportion of red cell mass to plasma to
be measured. Recall # Z-0613-2010;
3) Mikro 20 Centrifuge with 2076 Rotor TYP #2004 and TYP #2004-01. Used
for the purpose of determining the hematocrit count of a patient sample
by way of applying centrifugal force in a manner that separates red
blood cells and allows the proportion of red cell mass to plasma to be
measured. Recall # Z-0614-2010;
4) Haematokrit 20 Centrifuge with 2050 Rotor TYP #2014-01 and
TYP#201424-01. Used for the purpose of determining the hematocrit count
of a patient sample by way of applying centrifugal force in a manner
that separates red blood cells and allows the proportion of red cell
mass to plasma to be measured. Recall # Z-0615-2010
4) Units with plastic motor housing. TYP #2014-01 and TYP#201424-01
MANUFACTURER: Recalling Firm: Hettich Instruments Management I, Beverly,
MA, by email on November 21, 2009, and by letter dated November 23,
2009. Manufacturer: Andreas Hettich Gmbh & Co. Kg, Tuttlingen, Germany.
Firm initiated recall is ongoing.
REASON: Centrifuge Rotor Failure: may crack, break, and explode outside
the centrifuge.
PRODUCT :
1) Exel Huber Needles (Right angle and Straight Models with Catalog
Numbers: a) 26901CE, 26902CE, 26903CE, 26904CE, 26905CE, 26906CE,
26907CE, 26908CE, 26909CE, 26910CE, 26911CE, 26921CE, 26922CE, 26923CE,
26924CE, 26925CE, 26926CE, 26927CE, 26928CE, and 26929CE). Recall #
Z-0638-2010;
2) Exel Safety Huber Infusion Sets (20G and 22G sizes with Catalog
Numbers 37854S, 37855S. 37858S). Recall # Z-0639-2010;
3) Exel Huber Infusion Set, Catalog Numbers 26940R, 26941R, 26944R,
26945R, 26946R, 26948R, 26949R, 26950R, 27940R, 27941R, 27944R, 27945R,
27946R, 27948R, 27949R, 27950R, 26954R, 26955R, 26958R, 26959R, 27954R,
27955R, 27958R, 27959R. Recall # Z-0640-2010
MANUFACTURER: Recalling Firm: Exelint International Co., Culver City CA,
by letter on December 25, 2009. Manufacturer: Nissho Insurance Services
Co., Ltd., Osaka-shi, Japan. Firm initiated recall is ongoing.
REASON: Non-coring needles that, when inserted into an implanted port,
were shown to core the silicone ports septum. Coring of port's septum
may lead to: decreased effectiveness of port, infection, necrosis,
swelling, and embolization, which may result in pulmonary embolism, limb
ischemia, stroke, local extravasation of medication such as chemotherapy
or other caustic material; may lead to local tissue necrosis,
granulomas, failure to deliver therapy, need for additional surgery to
replace implanted ports, and/or death. Coring tests demonstrate that the
Exel Huber Needles core 60-74%.
PRODUCT: Edwards Lifesciences "Aquarius" System; Model Numbers:
GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software
version 6.00.04. The Aquarius monitors the fluid going into and coming
out of the patient. Recall # Z-0653-2010
MANUFACTURER: Recalling Firm: Edwards Lifesciences, LLC, Irvine, CA, by
letter dated March 19, 2009. Manufacturer: NIKKISO Medical Systems GMBH,
Hannover, Germany. Firm initiated recall is ongoing.
REASON: Reports of clinically significant fluid imbalance. When a
certain level of fluid imbalance is detected, the Aquarius will trigger
an alarm. However, users are able to override this alarm and continue
therapy. By repeatedly overriding the balance alarm without solving the
issue (closed clamp, kinked line, etc.), it is possible to remove too
much fluid from or replace too much fluid to the patient. In extreme
cases, this could result in hypovolemia or hypervolemia, other serious
injury or death. Edwards will be providing a software upgrade that is
intended to prevent the user from bypassing the fluid balance alarm more
than five times in a 20-minute period.
CLASS II
PRODUCT:
1) GE OEC 9900 Elite ESP, to produce mobile fluoroscopic images of human
anatomy. Recall # Z-0004-2010;
2) GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic
images of human anatomy. Recall # Z-0005-2010
MANUFACTURER: GE Healthcare, Salt Lake City, UT, by letter beginning
October 5, 2009. Firm initiated recall is ongoing.
REASON: A software defect - may result in a false indication and warning
on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode
is over-heated. This will also cause the displayed air kerma rate and
cumulative air kerma to be inaccurate.
PRODUCT:
1) Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter,
130 mm stem length, 42 degrees, sterile, REF 4342-112-13. Shoulder
replacement surgery. Recall # Z-0177-2010;
2) Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter,
130 mm stem length, 48 degrees, sterile, REF 4348-112-13. Shoulder
replacement surgery. Recall # Z-0178-2010
MANUFACTURER: Zimmer, Inc., Warsaw, IN, by e-mail on September 19, 2009
and letter dated September 29, 2009. Firm initiated recall is complete.
REASON: Some of the devices may possess a taper which will not mate with
the humeral head, as intended.
PRODUCT: Richard Wolf Hulka Clip; for single patient use only; a
sterile tubal occluding device; 2 clips per procedure tray/pouch, 10
pouches per shipping carton; item 4986.90. Indicated for use for female
sterilization (permanent contraception) by occluding the fallopian
tubes. Recall # Z-0272-2010
MANUFACTURER: Richard Wolf Medical Instruments, Corp., Vernon Hills, IL,
by letters dated October 16, 2009. Firm initiated recall is ongoing.
REASON: The sterile pouch seal may fail to remain intact during handling
rendering the Hulka clip non-sterile.
PRODUCT:
1) Imager" II Angiographic Catheters, Sterilized with ethylene oxide
gas, Made in Ireland, Unit 7,8 & 9 Material Number (Outer Carton Label
of 5pk) /Material Number (Inner-Pouch Label for each Single Catheter)/
Catalog Number /Material Description: M001314001 M001314000 31-400
IMAGER II/5/ST/65/038 BX5; M001314021 M001314020 31-402 IMAGER
II/5/ST/65/035 BX 5; M001314071 M001314070 31-407 IMAGER
II/5/BERN/40/035 BX 5; M001314081 M001314080 31-408 IMAGER
II/5/BERN/40/038 BX5; M001314091 M001314090 31-409 IMAGER
II/5/BERN/65/035 BX 5; M001314101 M001314100 31-410 IMAGER
II/5/BERN/65/038 BX5; M001314301 M001314300 31-430 IMAGER
II/5/SIM1/65/038 BX5; M001314521 M001314520 31-452 IMAGER
II/5/CHGB/65/038 BX5; M001314561 M001314560 31-456 IMAGER
II/5/CHG2.5/65/038 BX5; M001314571 M001314570 31-457 IMAGER
II/5/CHG2.5/65/035 BX 5; M001314581 M001314580 31-458 IMAGER II/5/CONTRA
2/65/038 BX5; M001314591 M001314590 31-459 IMAGER II/5/CONTRA 2/65/035
BX 5; M001314611 M001314610 31-461 IMAGER II/5/DUCK/65/035 BX 5;
M001314661 M001314660 31-466 IMAGER II/5/C2/65/038 BX5; M001314671
M001314670 31-467 IMAGER II/5/C2/65/035 BX 5; M001314681 M001314680
31-468 IMAGER II/5/C2+2 SIDE HOLES/65/038 BX5; M001314691 M001314690
31-469 IMAGER II/5/C2+2 SIDE HOLES/65/035 BX 5; M001314751 M001314750
31-475 IMAGER II/5/TRAIN/65/038 BX5; M001314761 M001314760 31-476 IMAGER
II/5/MIK/65/038 BX5; M001314791 M001314790 31-479 IMAGER
II/5/HK1.0/65/035 BX 5; M001314801 M001314800 31-480 IMAGER
II/5/SHK0.8/65/038 BX5; M001314811 M001314810 31-481 IMAGER
II/5/SHK0.8/65/035 BX 5; M001314821 M001314820 31-482 IMAGER
II/5/SHK1.0/65/038 BX5; M001314851 M001314850 31-485 IMAGER
II/5/RC1/65/035 BX 5; M001314861 M001314860 31-486 IMAGER
II/5/RC2/65/038 BX5; M001314881 M001314880 31-488 IMAGER II/5/RDC/65/038
BX5; M001314891 M001314890 31-489 IMAGER II/5/RDC/65/035 BX 5 and
M001314911 M001314910 31-49I IMAGER II/5/RDC+2 SIDEHOLES/65/035 BX 5:
M001315001 M001315000 31-500 IMAGER II/4/TENNIS RACQUET/65/035 BX5;
M001315031 M001315030 31-503 IMAGER II/5/TENNIS RACQUET/65/035 BX5;
M001315061 M001315060 31-506 IMAGER II/5/TENNIS RACQUET/65/038 BX5;
M001315091 M001315090 31-509 IMAGER II/4/PIGTAIL/65/035 BX5; M001315101
M001315100 31-510 IMAGER II/4/STRAIGHT/65/035 BX5; M001315131 M001315130
31-513 IMAGER II/5/PIGTAIL/65/038 BX5; M001315161 M001315160 31-516
IMAGER II/5/STAIGHT/65/038 BX5; M001315191 M001315190 31-519 IMAGER
II/5/PIGTAIL/65/035 BX5; M001315201 M001315200 31-520 IMAGER
II/5/STRAIGHT/65/035 BX5; M001315251 M001315250 31-525 IMAGER
/4/CONTRALATERAL/65/035 BX5; M001315281 M001315280 31-528IMAGER
II/5/CONTRALATERAL/65/035 BX5; M001315311 M001315310 31-531 IMAGER
II/5/CONTRALATERAL/65/038 BX5; M001316021 M001316020 31-602 MODEL-IMAGER
II/ 4/ ST/65/035; M001316071 M001316070 31-607 MODEL-IMAGER II/ 4/
BERN/40/035; M001316091 M001316090 31-609 MODEL-IMAGER II/ 4/
BERN/65/035; M001316311 M001316310 31-631 MODEL-IMAGER II/ 4/
SIM1/65/035; M001316531 M001316530 31-653 MODEL-IMAGER II/ 4/
CHGB/65/035; M001316551 M001316550 31-655 MODEL-IMAGER II/ 4/
CHGC/65/035; M001316581 M001316580 31-658 MODEL-IMAGER II/ 4/ CONTRA
2/65/035; M001316691 M001316690 31-669 MODEL-IMAGER II/4/C2+2 SIDE
HOLES/65/035 and M001316851 M001316850 31-685 MODEL-IMAGER II/ 4/
RC1/65/035. Imager" II Angiographic Catheters are sterile, single-use
diagnostic intravascular catheters. These catheters are available in a
variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90
cm and 100 cm. The distal segment of the catheter is radiopaque to aid
in visualization of the device under fluoroscopy. Recall # Z-0336-2010;
2) Imager" II Urology Torque Catheter, Sterilized with ethylene oxide
gas, Unit 7,8 & 9. Product Description and Material/UPN/Catalog Number
Imager" II Catheters C2, 5Fr, 65cm M0064003010 (inner pouch) M0064003011
(outer box); Imager" II Catheters Straight, 5Fr, 65cm M0064003020 (inner
pouch) M0064003021 (outer box) and Imager" II Catheters Bern, 5Fr, 65cm
M0064003030 (inner pouch) M0064003031 (outer box) The Imager II Urology
Torque Catheter is single lumen, torqueable catheter that is offered
with one of a variety of tip configurations, each uniquely designed to
facilitate access to the urinary tract. This device is made of a
bio-compatible polymer reinforced with a stainless steal braided wire
with one hole at the distal tip and a luer lock hub is attached to the
proximal end. The catheter may be used with a guidewire up to .038 in.
diameter. Recall # Z-0337-2010.
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Maple Grove, MN,
by letters on October 29, 2009. Manufacturer: TFX Engineering LTD.,
Teleflex Medical, Limerick, Ireland. Firm initiated recall is ongoing.
REASON: The sterile barrier in the packaging (pouch) that contains the
catheter may be breached. The breach of sterility could lead to a
contamination of the device with subsequent transfer of infectious
agents to the patient.
PRODUCT:
1) Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, H3000WN,
H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS. Generating
head and whole body CT images of human subjects. Recall # Z-0494-2010;
2) Infinia with Hawkeye 4, model numbers: H3000WC and H3000WD.
Generating head and whole body CT images of human subjects. Recall #
Z-0495-2010;
3) Millenium VG with Hawkeye/Discovery VH with Hawkeye, model number:
BR321000008. Generating head and whole body CT images of human subjects.
Recall #Z-0496-2010.
MANUFACTURER: GE Medical Systems, LLC, Waukesha, WI, by letter February
2010. Firm initiated recall is ongoing.
REASON: Failure to provide the complete User Manual information.
PRODUCT:
1) Ellex Motorized Safety Filter, Zeiss; Model number 6339585. Intended
for photocoagulation. Recall # Z-0577-2010;
2) Motorized Safety Filter, Wild; Model number 6339590. Intended for
photocoagulation. Recall # Z-0578-2010
MANUFACTURER: Ellex Medical Pty LTD, Adelaide, Australia, by letter
February 11, 2009. Firm initiated recall is ongoing.
REASON: Potential for two screws important in the design of the safety
filter to come loose.
PRODUCT: SoftLase Pro Dental Lasers Intended use: Dentistry. Recall #
Z-0587-2010
MANUFACTURER: Zap Lasers LLC, Pleasant Hill, CA, by letter December 30,
2009. Firm initiated recall is ongoing.
REASON: The SoftLase Lasers are in need of compliance upgrades due to
lack of a remote interlock connector, an emission delay, user guide
labels and locations, and calibration procedures and schedule.
PRODUCT:
1) iDXA, GE Lunar DEXA bone densitometers operating with enCORE software
versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate
of BMD. Recall # Z-0600-2010;
2) Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with
enCORE software versions 12.0, 12.1, 12.2, 13.0, & 13.1. The systems
provide an estimate of BMD. Recall # Z-0601-2010;
3) DPX-NT series, GE Lunar DEXA bone densitometers operating with enCORE
software versions 12.0, 12.1, 12.2, 13.0, & 13.1. The systems provide an
estimate of BMD. Recall # Z-0602-2010;
4) DPX-MD series, GE Lunar DEXA bone densitometers operating with enCORE
software versions 12.0, 12.1, 12.2, 13.0, & 13.1. The systems provide an
estimate of BMD. Recall # Z-0603-2010;
5) DPX-Bravo/Duo, GE Lunar DEXA bone densitometers operating with enCORE
software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an
estimate of BMD. Recall # Z-0604-2010
MANUFACTURER: GE Healthcare, Wauwatosa, WI, by letter on November 2,
2009. Firm initiated recall is ongoing.
REASON: Failure to properly pre-indicate the technique factors to be
used during a patient scan.
PRODUCT: GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800
is a portable EGG acquisition, analysis and recording system. The MAC
800 is intended to acquire, analyze, display and record information from
adult and pediatric populations. Pediatric population is defined as
patients between the ages of 0 and 15 years. The MAC 800 is intended to
be used by trained operators in a hospital or medical professional's
facility environment to record EGG signals from surface electrodes. The
basic system shall provide 2 modes of operation: (I) Resting EGG mode
and (2) Arrhythmia mode. The basic systems shall print 3, 6-leads of
EGG. The device shall be upgradeable to provide software options such as
12-lead ECG measurement and interpretive analysis. Recall # Recall #
Z-0645-2010.
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha, WI,
letter dated December 10, 2009. Manufacturer: GE Medical Systems China
Co., Ltd., Wuxi, China. Firm initiated recall is ongoing.
REASON: GE Healthcare has become aware of an issue with MAC800 laser
printouts. When more than one ECG report in the file manager is batch
printed in laser print, the potential exists for an incorrect patient
identification or name to be displayed on the print out.
Misidentification of patient data potentially contributing to delayed or
incorrect treatment is then possible.
PRODUCT:
1) AC Power Cords, 110V. Power Cord #4100079 used with a) Kinair IV
Model 22600, b) Kinair IV 60601 Model 216050, c) Triadyne Proventa Model
406000, d) Therapulse ATP/II Models 227800 and 227080.S, e) Kinair
Medsurg Model 201001W, and f) Kinair Medsurg Pulse Model 40900. Recall #
Z-0662-2010;
2) AC Power Cords, 110V. Power Cord #4102204 used with a) Tricell 60601
Model 212857, b) First Step Select Model 215200, and c) Plexipulse Model
205835. Recall # Z-0663-2010;
3) AC Power Cords, 110V. Power Cord #M4268840 used with a) First Step
All-In-One Canadian French Models 227500-09 and 227500, b) First Step
All-In-One English Model 227500, c) Therakair Visio Models M8259978 and
M6257763 pump only, and d) Proficare - Canada Model M8259988. Recall #
Z-0664-2010;
4) AC Power Cords, 110V. Power Cord #340225 used with a) Activac Model
340000, and b) ActiVAC (Canadian) Model 340013. Recall # Z-0665-2010;
5) AC Power Cords, 110V. Power Cord #M4268882 used with a) InfoVAC Model
M825999, b) InvoVac Canadian Model M8260027, and c) Vac ATS Model
8259968. Recall # Z-0666-2010;
6) AC Power Cords, 110V. Power Cord M426884 used with VAC ATS Canadian
Model M8259994. Recall # Z-0667-2010
MANUFACTURER: Recalling Firm: KCI USA, Inc., San Antonio, TX, by letter
dated November 4, 2009. Manufacturer: Electri-Cord Manufacturing Co.,
Westfield, PA. Firm initiated recall is ongoing.
REASON: Power cords may crack and fail inside plug with potential for
fire hazard.
PRODUCT:
1) Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 1.2um
Filter, Pressure limited check valve 111 in V7412F. Product code 352425.
Recall # Z-0670-2010;
2) Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 0.2um
Filter, Pressure limited check valve 122 in V7415F. Product code 352428.
Z-0671-2010;
3) Outlook Pump IV Set w/Universal Spike, 2 Safesite Inj sites, 0.2um
Filter, Pressure limited check valve 122 in SS3169F. Product Code
352429. Recall # Z-0672-2010
4) Outlook Pump IV Set w/Universal Spike, 2 Safesite Inj sites, 0.2um
Filter, Pressure limited check valve 122 in NF3169F. Product code
352430. Recall # Z-0673-2010;
5) Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj sites, 0.2um
Filter, Pressure limited check valve 119 in US3169F. Product code
352442. Recall # Z-0674-2010;
6) Outlook Pump Add On Set with Ultrasite Injection Site Spin Lock
Connector 88 in US3110. Product Code 352458. Z-0675-2010;
7) Outlook Pump IV Set w/Universal Spike, Injection Site 0.2um Filter
Spin Lock Connector 115 in V7416F. Product Code 352461. Recall #
Z-0676-2010;
8) Outlook Pump IV Set w/Universal Spike, Ultrasite Injection Site 0.2um
Filter Ultrablock Tubing 119 in UV3169F. Product Code 352472. Recall #
Z-0677-2010;
9) Outlook Pump IV Set w/Universal Spike, 3 Ultrasite Inj Sites B/C
Valve & Pressure Limited Check Valve 136 in US1500HP. Product Code
352520. Recall # Z-0678-2010;
10) Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj
Site, 2 Ultrasite Inj Sites, Check Valve 120 in US3116M. Product Code
375038. Recall # Z-0679-2010;
11) Outlook Pump Set w/150 ml Burette w/Ultrasite Inj Site & 15um
Filter, 2 Ultrasite Inj Sites, Check Valve 120 in US3116M. Product Code
375040. Recall # Z-0680-2010;
12) Outlook Pump Set w/150 ml Burette w/Ultrasite Inj Site & 15um
Filter, 2 Safesite Inj Sites, Check Valve 120 in SS3115M. Product Code
375043. Recall # Z-0681-2010;
13) Outlook Pump Set w/150 ml Burette w/15um Filter & Inj Site, Check
Valve, 2 Inj Sites, 120 in V7421M. Product Code 375118. Recall #
Z-0682-2010;
14) Outlook Pump Set w/150 ml Burette w/15um Filter & Safeline Inj Site,
Check Valve, 2 Safeline Inj Sites, 120 in NF3115M. Product Code 375122.
Recall # Z-0683-2010;
15) Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj
Site, B/C Valve, 2 Ultrasite Inj Sites, 120 in US3121M. Product Code
375150. Recall # Z-0684-2010;
16) Outlook Pump Set w/Universal Spike, 3 Ultrasite Inj Sites, Spin Lock
Con & Pressure, Limited Check Valve, 134 in US3140. Product Code 375196.
Recall # Z-0685-2010;
17) Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, B/C Valve
and Pressure Limited Check Valve, 124 in US1502HP. Product Code 470018.
Recall # Z-0686-2010;
18) Outlook Pump IV Set with Universal Spike and Spin Lock Connector 133
in 1500HP. Product Code 470019. Recall # Z-0687-2010;
19) Outlook Pump IV Set w/Universal Spike, Supor Membrane 1.2um Filter,
Spin Lock Connector 123 in 1500FHP. Product Code 470020. Recall #
Z-0688-2010;
20) Outlook Pump IV Set w/Universal Spike & Spin Lock Connector 118 in
V1500HP. Product Code 470025. Recall # Z-0689-2010;
21) Outlook Pump IV Set w/Universal Spike, 1 Safeline & 3 Ultrasite Inj
Sites, Check Valve, B/C Valve 119 in US1500XHP. Product Code 470026.
Recall # Z-0690-2010;
22) Outlook Pump IV Set w/Universal Spike Check Valve, 4 Ultrasite Inj
Sites, 3 B/C Valves, Spin Lock Connector 140 in US1504HP. Product Code
470042. Recall # Z-0691-2010;
23) Outlook Pump IV Set w/Universal Spike Pressure Limited Check Valve,
2 B/C Valves, 3 Ultrasite Inj Sites, 137 in US1505HP. Product Code
470043. Recall # Z-0692-2010;
24) Outlook Pump IV Set w/Universal Spike, Back Check Valve, Ultrasite
Inj Site, Spin Lock Connector, 128 in US1506HP. Product Code 470046.
Recall # Z-0693-2010;
25) Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, 1.2um
Filter, Spin Lock Connector, 120 in US3112F. Product Code 474001. Recall
# Z-0694-2010;
26) Outlook Pump IV Set w/Universal Spike, Check Valve, 3 Safeline Inj
Sites, B/C Valve, 3 N/C Valves Stopcock, 118 in NF1500M3HP. Product Code
490021. Recall # Z-0695-2010;
27) Outlook Pump IV Set w/Universal Spike, Check Valve, 3 Ultrasite Inj
Sites, B/C Valve, 2 N/C Valves Stopcock, 116 in US1500M2HP. Product Code
490022. Recall # Z-0696-2010;
28) Outlook Pump IV Set w/Universal Spike, Check Valve, 4 Safeline Inj
Sites, B/C Valve, 3 N/C Valves Stopcock, 138 in NF1501M3HP. Product Code
490049. Recall # Z-0697-2010;
29) Outlook Pump IV Set w/Universal Spike, Check Valve, 5 Ultrasite Inj
Sites, Ultraport HF Stopcock, 148 in US1500UPHP. Product Code 490071.
Recall # Z-0698-2010;
30) 15 Drop Universal IV Admin Set w Outlook Cassette Ultrasites and
Ultraport Stopcock 132 in US1501UPHP. Product Code 490074. Recall #
Z-0699-2010;
31) Outlook Pump IV Set w/Universal Spike, Pressure limited check Valve,
Spin Lock Connector, 3 Safeline Inj Sites, 120 in. Product Code NF3106.
Recall # Z-0700-2010;
32) Safeline Y Type Blood Set for Outlook Pump w/Safeline Inj Site,
170um Blood Filter, Spin lock Connector 138 in. Product Code NF3120.
Recall # Z-0701-2010;
33) Outlook Pump IV Set w/Universal Spike, 2 Safeline Injection Sites,
Spin Lock Connector 120 in. Product Code NF3130. Recall # Z-0702-2010;
34) Outlook Pump IV Set w/Universal Spike, 3 Safeline Inj Sites, Spin
Lock Conn & Pressure Limited Check Valve 134 in. Product Code NF3140.
Recall # Z-0703-2010;
35) Outlook Pump IV Set with Universal Spike, Check Valve, 3 Safeline
Inj Sites, B/C Valve, Spin Lock Connector 122 in. Product Code
NF3140-10. Recall # Z-0704-2010;
36) Safesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um
Blood Filter, Spin Lock Connector 132 in. Product Code SS3120. Recall #
Z-0705-2010;
37) Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve,
3 Safsite Inj Sites, Spin Lock Connector 134 in. Product Code SS3140.
Recall # Z-0706-2010;
38) Safesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um
Blood Filter, Spin Lock Connector 132 in. Product Code US3120. Recall #
Z-0707-2010;
39) Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve,
3 Ultrasite Injection Sites, 129 in. Product Code US3130. Recall #
Z-0708-2010;
40) Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj Sites, Spin
Lock Con & Pressure Limited Check Valve, 127 in. Product Code US3180.
Recall # Z-0709-2010;
41) Outlook Pump Add On Set with Injection Site & Spin Lock Connector,
90 in. Product Code V7400. Recall # Z-0710-2010;
42) Outlook Pump Syringe Add On Set w/Microbore Tubing, Injection Site,
Spin Lock Connector, 88 in. Product Code V7401. Recall # Z-0711-2010;
43) Outlook Pump Add On Set for Epidural Administration w/Microbore
tubing & Sliding Spin Lock Connector, 88 in. Product Code V7402. Recall
# Z-0712-2010;
44) Outlook Pump IV Set w/Universal Spike, Injection Site & Spin Lock
Connector, 132 in. Product Code V7405. Recall # Z-0713-2010;
45) Outlook Pump IV Set with Universal Spike, Pressure Limited Check
Valve, 3 Inj Sites, Spin Lock Connector, 132 in. Product Code V7410.
Recall # Z-0714-2010;
46) Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve,
3 Inj Sites, Spin Lock Connector, 132 in. Product Code V7413. Recall #
Z-0715-2010;
47) Outlook Pump Nitroglycerin Set w/Universal Spike & Spin Lock
Connector, 135 in. Product Code V7450. Z-0716-2010;
48) Outlook Pump IV Set for Epidural Admin w/Universal Spike, Microbore
Tubing, Spin Lock Connector, 126 in. Product Code V7453. Recall #
Z-0717-2010;
49) Outlook Pump Y Type Blood Set with 170um Blood Filter, Injection
Site, Spin Lock Connector, 131 in. Product Code V7490. Recall #
Z-0718-2010
MANUFACTURER: Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by
letters on November 30, 2009 and December 1, 2009. Manufacturer: B.
Braun Medical Inc., Santo Domingo, Dominican Republic. Firm initiated
recall is ongoing.
REASON: System error 9 alarms. A System Error 9 alarm indicates a
potential pressure loss in the pump cassette delivery chamber (chamber
closest to the patient). This alarm is generated during the pumps
initiation sequence and will not allow the set to be utilized. This
requires a new set to be obtained, thus creating a potential for delay
in therapy.
PRODUCT:
1) Stryker CBCII ConstaVac Blood conservation system, sterile, REF
225-28E. Blood recovery system used post-operatively to collect, filter
and allow for reinfusion of autologous blood. Recall # Z-0719-2010;
2) Stryker CBCII collection only pkg/6, sterile, REF 225-28-S20. Blood
recovery system used post-operatively to collect, filter and allow for
reinfusion of autologous blood. Recall # Z-0720-2010;
3) Stryker CBC Blood Conservation Kit with Quick Disconnect Blood Bag,
sterile, REF 225-28-85. Blood recovery system used post-operatively to
collect, filter and allow for reinfusion of autologous blood. Recall #
Z-0721-2010;
4) Stryker CBCII 1/8in. Double Trocar with quick disconnect , sterile,
REF225-28-85S1. Blood recovery system used post-operatively to collect,
filter and allow for reinfusion of autologous blood. Recall #
Z-0722-2010;
5) Stryker CBCII with Quick Disconnect, 3/16 in. Double Trocar and
Reinfusion Labels, sterile, REF 225-28-85S4. Blood recovery system used
post-operatively to collect, filter and allow for reinfusion of
autologous blood. Recall # Z-0723-2010;
6) Stryker CBCII with Quick Disconnect and 3/16 in. Double Trocar,
sterile, REF 225-28-S5. Blood recovery system used post-operatively to
collect, filter and allow for reinfusion of autologous blood. Recall #
Z-0724-2010;
7) Stryker CBCII Blood Conservation Kit w/ 1/8 in. (3.2mm) Round PVC
Drain and Curved Trocar, sterile; REF 225-28-514. Blood recovery system
used post-operatively to collect, filter and allow for reinfusion of
autologous blood. Recall # Z-0725-2010;
8) Stryker CBCII Blood Conservation Kit w/ 1/4 in. (6.4mm) Round PVC
Drain and Curved Trocar, sterile, REF 225-28-516. Blood recovery system
used post-operatively to collect, filter and allow for reinfusion of
autologous blood. Recall # Z-0726-2010;
9) Stryker CBCII Blood Conservation Kit w 3/16in. (4.8mm) round PVC
Drain and Curved Trocar, sterile, REF 225-28-526. Blood recovery system
used post-operatively to collect, filter and allow for reinfusion of
autologous blood. Recall # Z-0727-2010;
10) Stryker CBCII Double Trocar Kit with 1/8 in. (3.2mm) Drain, sterile,
REF 225-28-614. Blood recovery system used post-operatively to collect,
filter and allow for reinfusion of autologous blood. Recall #
Z-0728-2010;
11) Stryker CBCII Double Trocar Kit with 1/4in. (6.4mm) Drain, sterile,
REF 225-28-616. Blood recovery system used post-operatively to collect,
filter and allow for reinfusion of autologous blood. Recall #
Z-0729-2010;
12) Stryker CBCII Double Trocar Kit with 3/16in. (4.8mm) Drain, sterile,
REF 225-28-626. Blood recovery system used post-operatively to collect,
filter and allow for reinfusion of autologous blood. Recall #
Z-0730-2010;
13) Stryker CBCII Double Trocar/Double Pouch Kit with 3/16in. (4.8mm)
Drain, sterile, REF 225-28-626S1. Blood recovery system used
post-operatively to collect, filter and allow for reinfusion of
autologous blood. Recall # Z-0731-2010;
14) Stryker CBCII ConstaVac Blood Conservagtion System w/ Quick
Disconnect and 1/8in. (3.2mm) PVC Drain, sterile, REF 225-28-914. Blood
recovery system used post-operatively to collect, filter and allow for
reinfusion of autologous blood. Recall # Z-0732-2010;
15) Stryker CBCII ConstaVac Blood Conservation System with Quick
Disconnect and 1/4in. (6.4mm) PVC Drain, sterile, REF 225-28-916. Blood
recovery system used post-operatively to collect, filter and allow for
reinfusion of autologous blood. Recall # Z-0733-2010;
16) Stryker CBCII ConstaVac Blood Conservation System w/Quick Disconnect
and 3/16in. (4.8mm) PVC Drain, sterile, REF 225-28-926. Blood recovery
system used post-operatively to collect, filter and allow for reinfusion
of autologous blood. Recall # Z-0734-2010;
17) Stryker CBCII ConstaVac Blood Collection Only System with 1/8in.
(3.2mm) PVC Drains and Double 1/8in. (3.2mm) Trocar, sterile, REF
225-29. Blood recovery system used post-operatively to collect, filter
and allow for reinfusion of autologous blood. Recall # Z-0735-2010;
18) Stryker CBCII ConstaVAc Blood Conservatin Kit 1/8in. (3.2mm) PVC,
sterile, REF 225-414. Blood recovery system used post-operatively to
collect, filter and allow for reinfusion of autologous blood. Recall #
Z-0736-2010;
19) Stryker CBCII ConstaVac Blood Conservation Kit 1/8in. (3.2mm) PVC
w/o Fat Retention Valve, sterile, REF 225-414S2. Blood recovery system
used post-operatively to collect, filter and allow for reinfusion of
autologous blood. Recall # Z-0737-2010;
20) Stryker CBCII ConstaVac Blood Conservaion Kit 1/8in. (3.2mm) PVC,
sterile, REF 225-414-W. Blood recovery system used post-operatively to
collect, filter and allow for reinfusion of autologous blood. Recall #
Z-0738-2010;
21) Stryker CBCII ConstaVac Blood Conservation Kit 1/4in. (6.4mm) PVC,
sterile, REF 225-416. Blood recovery system used post-operatively to
collect, filter and allow for reinfusion of autologous blood. Recall #
Z-0739-2010;
22) REF 225-426. Blood recovery system used post-operatively to collect,
filter and allow for reinfusion of autologous blood. Recall #
Z-0740-2010;
23) Stryker CBCII with 3/16 in. Silicone Drain, sterile, REF
0225-028-S16. Blood recovery system used post-operatively to collect,
filter and allow for reinfusion of autologous blood. Recall #
Z-0741-2010;
24) Stryker CBCII Collection only pkg/6 with 1/8 in Trocar, sterile, REF
0225-028-S21. Blood recovery system used post-operatively to collect,
filter and allow for reinfusion of autologous blood. Recall #
Z-0742-2010;
25) Stryker CBC ConstaVac Blood Conservation Kit 3/16in. (4.8mm) PVC,
sterile, REF 225-426-W. Blood recovery system used post-operatively to
collect, filter and allow for reinfusion of autologous blood. Recall #
Z-0743-2010
MANUFACTURER: Recalling Firm: Stryker Medical Div. of Stryker Corp.,
Portage, MI, by letter dated November 12, 2009. Manufacturer: Stryker
Puerto Rico, LTD, Arroyo, PR. Firm initiated recall is ongoing.
REASON: The product may not be sterile due to package not being intact.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of Recalls as of
January 27, 2009
CLASS I
PRODUCT: TrailBlazer Support Catheter, Rx Only, Sterile EO. US Model
Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150,
SC-018-150, SC-035-090, and SC-035-150. Intended to guide and support a
guide wire during access of the vasculature. Recall # Z-0497-2010.
MANUFACTURER: Ev3, Inc., Plymouth, MN, by letter dated November 6, 2009.
Firm initiated recall is ongoing.
REASON: The TrailBlazer" Support Catheter may crack near the radiopaque
marker band at the distal end of the device during use. Cracking of the
catheter shaft in this location can result in material separation, and
potential embolization.
CLASS IIr>
PRODUCT
1) Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number:
MN1610. Bard Magnum Disposable Biopsy Core Needle is intended for use in
obtaining biopsies from soft tissues such as liver, kidney, prostate,
breast, spleen, lymph nodes and various soft tissue tumors. Recall #
Z-0273-2010;
2) Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number:
MN1613. Bard Magnum Disposable Biopsy Core Needle is intended for use in
obtaining biopsies from soft tissues such as liver, kidney, prostate,
breast, spleen, lymph nodes and various soft tissue tumors. Recall #
Z-0274-2010;
3) Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number:
MN1616. Bard Magnum Disposable Biopsy Core Needle is intended for use in
obtaining biopsies from soft tissues such as liver, kidney, prostate,
breast, spleen, lymph nodes and various soft tissue tumors. Recall #
Z-0275-2010;
4) Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number:
MN1620. Bard Magnum Disposable Biopsy Core Needle is intended for use in
obtaining biopsies from soft tissues such as liver, kidney, prostate,
breast, spleen, lymph nodes and various soft tissue tumors. Recall #
Z-2076-2010.
MANUFACTURER: Bard Peripheral Vascular Inc., Tempe, AZ, by letter on
October 08, 2009. Firm initiated recall is ongoing.
REREASON: The recall was initiated after the firm determined that some
Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an
exposed sample chamber, due to extended stylet length resulting from a
loose hub connection. The exposed sample chamber will typically result
in an inability to obtain the biopsy sample. In the majority of reported
cases, there was no injury to the patient or user. When used in highly
vascular organs, the exposed sample chamber may, in rare instances,
result in trauma or puncture to neighboring tissue and lead to
subsequent bleeding as initiated.
PRODUCT: Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for
moderate joint impairment from painful arthritis (rheumatoid, osteo
and/or post-traumatic; revision of failed unicompartmental knee implant
or other procedure; and alternative to tibial osteotomy in patients with
unicompartmental arthritis. Recall # Z-0371-2010.r>
MANUFACTURER: Stelkast Co, Mcmurray, PA, by telephone on May 5-19, 2009.
Firm initiated recall is complete.
REASON: Incorrect size markings on component.
PRODUCT
1) SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead
ECG/SPo2, Respiration Bedside Patient Monitor with 8.4"display VM4 3
Lead ECG, NBP, SPo2, optional Predictive Temp Bedside Patient Monitor
with 8.4" display VM6 3/5 Lead ECG, NBP, Temp, optional SPo2 Bedside
Patient Monitor with 8.4" display or 3/5 Lead ECG, NBP, Temp, optional
SPo2 option IBP Bedside Patient Monitor with 8.4" display VM8 3/5 Lead
ECG, NBP, Temp, IPB, ET CO2, SPo2 Bedside Patient Monitor with 10"
display or 3/5 Lead ECG, NBP, Temp, IPB, SPo2 Bedside Patient Monitor
with 10" display Part number: VM3: 863077, 453564041661, 453564050161,
VM4: 863063, 453564024371, 453564021961, 453564024401, 453564021971 VM6:
863064,863065, 453564024421, 453564022001, 453564024441 VM8:
453564022041, 863066, 863068, 453564022081, 453564024461, 453564024481
The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for
monitoring, recording and alarming of multiple physiological parameters
of adults, pediatrics, and neonates in healthcare environments.
Additionally, the monitor is intended for use in transport situations
within a healthcare facility. Recall # Z-0372-2010;
2) SureSigns Vital Signs Monitors (VS3)-Vital Signs Viewer Central
Viewing Station View up to 12 VM monitors at 1 time Part number: 863069,
863070, 63071, 863072, 863073, 863074, 453564041251, 453564041261,
453564041271, 453564041281, 453564041291, 453564041301 The SureSigns
VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording
and alarming of multiple physiological parameters of adults, pediatrics,
and neonates in healthcare environments. Additionally, the monitor is
intended for use in transport situations within a healthcare facility.
Recall # Z-0373-2010;
3) SureSigns Vital Signs Viewer (VSV):Spot Check Vital Signs Monitor
with NBP (options to include Predictive Temperature only; SPo2 only;
SPo2 and Recorder only; SPo2 and Predictive Temperature only; or SPo2,
Predictive Temperature, and Recorder Part Number: 863067 and
453564041491 The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used
for monitoring, recording and alarming of multiple physiological
parameters of adults, pediatrics, and neonates in healthcare
environments. Additionally, the monitor is intended for use in transport
situations within a healthcare facility. Recall # Z-0374-2010.
MANUFACTURER: Philips Healthcare Inc., Andover, MA, by letter dated
October 2009. Firm initiated recall is ongoing.
REASON: Use of these devices at their maximum volume setting may result
in the premature failure of the internal speaker.
PRODUCT: Hocoma Lokomat-System with Pediatric Module Software Versions:
V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a, V5.0x. Powered
exercise equipment used to apply automated locomoter training for
hemiplegic and paraplegic patients. Recall # Z-0590-2010.
MANUFACTURER: Hocoma AG, Zuerich, Switzerland, by letter dated May 27,
2009. Firm initiated recall is ongoing.
REASON: Changes to the stored "sensitivity" values may occur and leads
to higher limits in the force and trajectory deviation.
PRODUCT: Bausch & Lomb SoFlex SE Foldable Intraocular Lens. UPC
4001404, Rx Only, STERILE. Intraocular lens indicated for primary
implantation for visual correction in adult patients where the
cataractous lens has been removed by phacoemulsification. The lens is
intended for placement in the capsular bag. Model Number: LI61SE. Recall
# Z-0591-2010.
MANUFACTURER: Recalling Firm: Bausch & Lomb Inc., Rochester, NY, by
telephone beginning November 19, 2009 and by follow-up letter dated
November 23, 2009.
Manufacturer: Bausch & Lomb Surgical, Inc., Clearwater, FL. Firm
initiated recall is ongoing.
REASON: Bausch & Lomb is recalling their Silicone L161SE Intraocular
Lens Lot 4916928 (23.5D) after receiving three customer complaints for
what appears to be opacification of the intraocular lens. The
opacification occurred within one week of implantation. In each reported
case the surgeon explanted the lens.
PRODUCT: Biomet 2.9 Micromax L-15 suture anchor, flexible long shaft,
#2 blue/white maxbraid, PLLA/PGA L-15, sterile; REF 905456. Intended for
use in soft tissue reattachment procedures in the shoulder, wrist, elbow
and knee. Recall # Z-0611-2010.
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated December 11,
2009. Firm initiated recall is ongoing.
REASON: The anchor label states it contains a flexible shaft, but this
lot actually contains a rigid shaft.
PRODUCT: Tornier Arthro Tunneler. For transossous fixation of tendons
to bone in rotator cuff repair. Catalog Number: SMB000101. Recall #
Z-0656-2010.
MANUFACTURER: TAG Medical Corp., Naharia, Israel, by letter dated
December 4, 2009. Firm initiated recall is ongoing.
REASON: Device failed to deploy the distal loop.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of Recalls as of
January 20, 2010
CLASS II
PRODUCT
1)1) Medtronic Sofamor Danek Extended Length Trocar, Item No.: 7578013,
Material: Stainless Steel, non-sterile, Rx only, Trocars used with the
CD HORIZON LEGACY" Percutaneous Peek Spinal System. Recall #
Z-0606-2010;
2) Medtronic Sofamor Danek Extended Length Trocar, Size: L=50MM, Item
No.: 7578014, Material: Stainless Steel, non-sterile, Rx only, Trocars
used with the CD HORIZON LEGACY" Percutaneous Peek Spinal System. Recall
# Z-0607-2010.
MANUFACTURER: Recalling Firm: Medtronic Sofamor Danek USA Inc., Memphis,
TN, by telephone and email on December 7, 2009 and by letter dated
December 10, 2009. Manufacturer: Medtronic Sofamor Danek Instrument
Manufacturing, Bartlett, TN. Firm initiated recall is ongoing.
REASON: The Trocar may not fully engage with the Rod Inserter or may
prematurely disengage.
PRODUCT
1) Omega IV and Omega V tables on GE Advantx-E imaging system, used for
general purpose diagnostic angiographic fluoroscopy and radiographic
studies. Recall # Z-0616-2010;
2) Omega IV and Omega V tables on GE Innova 2100IQ Digital Fluoroscopic
Imaging System. Recall # Z-0617-2010;
3) Omega IV and Omega V tables on GE Innova 3100/3100IQ GE Innova 3100 /
3100 IQ, Cardiovascular Imaging System. Recall # Z-0618-2010;
4) Omega IV and Omega V tables on GE Innova 4100/4100IQ GE Innova 4100 /
4100 IQ x-ray system. Recall # Z-0619-2010;
5) Omega IV and Omega V tables on GE Innova 2000 fluoroscopic x-ray
system. Recall # Z-0620-2010;
6) Omega IV and Omega V tables on GE Innova 2121-1Q/3131--1Q Biplane
Cardiovascular Imaging System. Recall # Z-0621-2010
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by
letter dated December 1, 2009. Manufacturer: GE Medical Systems, SCS,
Buc Cedex, France. Firm initiated recall is ongoing.
REASON: Potential table rotation of Omega IV and Omega V tables
affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ,
2121IQ and 3131IQ cardiovascular X-ray imaging systems. Due to potential
weakness of some table rotational brakes, an unintended table rotation
may occur while the table is locked. This issue could lead to a patient
fall if the unintended motion occurs during patient transfer.
PRODUCT: Cordis Aquatrack Hydrophilic Nitinol Guidewire, REF C3526-SSA,
Guidewire Diameter .035" Tip Length Flexible 3 cm, Sterile. Contents 5
Hydrophilic guidewires and torquing devices. Recall # Z-0623-2010
MANUFACTURER: Recalling Firm: Cordis Corp., Miami Lakes, FL, by letters
on August 25, 2009 and on October 20, 2009. Manufacturer: Argon Medical
Devices, Inc., Athens, TX. Firm initiated recall is ongoing.
REASON: Some of the guidewires in these two lots have a straight tip
(incorrect) rather than an angled tip (correct configuration for that
catalog number).
PRODUCTr>
1)1) Sorin / Clearglide EVH Small, REF KTV15, Sterile R. The device is
indicated for endoscopic and open tissue dissection, bipolar
coagulation, and transaction of blood vessels. Device is a single
patient use bipolar instrument that uses a bipolar electrosurgical
generator and is used predominately for endoscopic harvesting of the
saphenous vein from the leg for coronary bypass surgery. Recall #
Z-0624-2010;
2) Sorin / Clearglide EVH Low Profile, REF KTV16, Sterile R. The device
is indicated for endoscopic and open tissue dissection, bipolar
coagulation, and transaction of blood vessels. Device is a single
patient use bipolar instrument that uses a bipolar electrosurgical
generator and is used predominately for endoscopic harvesting of the
saphenous vein from the leg for coronary bypass surgery. Recall #
Z-0625-201;
3) Sorin / Clearglide EVH Small with Scissor, REF KTV17, Sterile R. The
device is indicated for endoscopic and open tissue dissection, bipolar
coagulation, and transaction of blood vessels. Device is a single
patient use bipolar instrument that uses a bipolar electrosurgical
generator and is used predominately for endoscopic harvesting of the
saphenous vein from the leg for coronary bypass surgery. Recall #
Z-0626-2010;
4) Sorin / Clearglide EVH Low Profile with Scissor, REF KTV18, Sterile
R. The device is indicated for endoscopic and open tissue dissection,
bipolar coagulation, and transaction of blood vessels. Device is a
single patient use bipolar instrument that uses a bipolar
electrosurgical generator and is used predominately for endoscopic
harvesting of the saphenous vein from the leg for coronary bypass
surgery. Recall # Z-0627-2010;
5) Sorin / Clearglide EVH Long View, REF KTV22, Sterile R. The device is
indicated for endoscopic and open tissue dissection, bipolar
coagulation, and transaction of blood vessels. Device is a single
patient use bipolar instrument that uses a bipolar electrosurgical
generator and is used predominately for endoscopic harvesting of the
saphenous vein from the leg for coronary bypass surgery. Recall #
Z-0628-2010;
6) Sorin / Clearglide EVH Long View with Scissor, REF KTV23, Sterile R.
The device is indicated for endoscopic and open tissue dissection,
bipolar coagulation, and transaction of blood vessels. Device is a
single patient use bipolar instrument that uses a bipolar
electrosurgical generator and is used predominately for endoscopic
harvesting of the saphenous vein from the leg for coronary bypass
surgery. Recall # Z-0629-2010;
7) Sorin / Clearglide Precision Bipolar, REF PBD01, Sterile R. The
device is indicated for endoscopic and open tissue dissection, bipolar
coagulation, and transaction of blood vessels. Device is a single
patient use bipolar instrument that uses a bipolar electrosurgical
generator and is used predominately for endoscopic harvesting of the
saphenous vein from the leg for coronary bypass surgery. Recall #
Z-0630-2010
MANUFACTURER: Sorin Group USA, Inc., Arvada, CO, by letter dated
November 24, 2009. Firm initiated recall is ongoing.
REASON: Vessel clamping device may break during use.
PRODUCT: GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with
ApexPro Telemetry version 3.9 software). Recall # Z-0631-2010.
MANUFACTURER: General Electric Medical Systems Information Technology,
Milwaukee, WI, by letter dated September 25, 2009. Firm initiated recall
is ongoing.
REASON: Potential misuse of the ApexPro Telemetry System and incorrect
message and alarm information in the ApexPro Operator's Manual may
impact patient safety. When ApexPro Telemetry systems are used with SpO2
oximeters: 1. ApexPro FH Transceiver can operate with the ApexPro FH
Xpod connected, but without ECG lead wires attached to the transceiver.
This is unintended use of the device that is not documented in product
labeling. 2. When ApexPro CH Xpod, ApexPro FH Xpod, or Apex Oximeter is
connected to the ApexPro telemetry transmitter/transceiver, the SpO2 "No
Data" Alarm does not function as specified in the ApexPro Operators
Manual.
PRODUCT
1) Gyrus ACMI PKS Seal Open Forceps, model 3103PK, 9-3/4" curved.
Sterile EO. The device is intended to be used with the PlasmaKinetic
electrosurgical generator, software version 1.61 or greater required or
the PlasmaKinetic with SuperPulse electrosurgical generator, software
version 2.0 or greater or G400 electrosurgical generator. Recall #
Z-0632-2010;
2) Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" straight.
Sterile EO. The device is intended to be used with the PlasmaKinetic
electrosurgical generator, software version 1.61 or greater required or
the PlasmaKinetic with SuperPulse electrosurgical generator, software
version 2.0 or greater or G400 electrosurgical generator. Recall #
Z-0633-2010;
3) Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" angled.
Sterile EO. The device is intended to be used with the PlasmaKinetic
electrosurgical generator, software version 1.61 or greater required or
the PlasmaKinetic with SuperPulse electrosurgical generator, software
version 2.0 or greater or G400 electrosurgical generator. Recall #
Z-0634-2010;
4) Gyrus ACMI PKS Seal Open Forceps, model 915000PK, 9-3/4" Curved Jaw.
Sterile EO. The device is intended to be used with the G400
electrosurgical generator. Recall # Z-0635-2010;
5) Gyrus ACMI PKS Seal Open Forceps, model 915005PK, 9-3/4" Straight
Jaw. Sterile EO. The device is intended to be used with the G400
electrosurgical generator. Recall # Z-0636-2010;
6) Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4" Angled Jaw.
Sterile EO. The device is intended to be used with the G400
electrosurgical generator. Recall # Z-0637-2010
MANUFACTURER: Recalling Firm: Gyrus ACMI Corp., Southborough, MA, by
letter dated August 15, 2009. Manufacturer: Gyrus Medical, Inc., Osseo,
MN. Firm initiated recall is ongoing.r>
REASON: It has been reported in complaints received by Gyrus ACMI that
there is a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK,
915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the
jaws may detach during the procedure and fall into the surgical field.
The detached shim may be undetected and be left behind in the patient.
This circumstance could subsequently cause complications. Further use of
this product should cease, affected product should be removed from
stockrooms and returned to Gyrus ACMI.
PRODUCT: Orthofix Spinal Implants; Pillar SA PEEK Spacer System
Instrument Case. Case contents: Implant Insertion Instrument, Straight
Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and
without retention, Flex Shaft Driver, Trial Insertion Instrument, Drill
Tips, Cover Plate Inserter, Cover Plate Driver, Cover Plate Holder,
Ratcheting Handle, Torque Limiting Handle, Hex Driver,
Distractors/Sizers, Sizers REF: 49-0021. The Pillar SA Implant Insertion
Instrument is intended for intraoperative use in placing/inserting
Pillar SA implants into a prepared interbody space. Recall #
Z-0641-2010.
MANUFACTURER: Recalling Firm: Orthofix, Inc., McKinney, TX, by letter
dated November 19, 2009. Manufacturer: Gauthier Biomedical, Inc.,
Grafton, WI. Firm initiated recall is ongoing.
REASON: The Pillar SA Implant Insertion Instrument 49-1100 may
experience resistance in turning the activation knob while releasing an
implant after intra-operative positioning.
PRODUCT: Remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref
R01626, 10 box. The firm name on the label is Remel. The product is a
solid medium recommended for use in qualitative procedures to screen
Staphylococcus aureus for resistance to penicillinase-resistant
penicillins (PRP, e,g. methicillin, nafcillin). Recall # Z-0644-2010.
MANUFACTURER: Remel, Inc., Lenexa, KS, letters dated December 8, 2009.
Firm initiated recall is ongoing.
REASON: The product may fail to adequately grow methicillin resistant
Staphylococcus aureus ATTC 43300 and Staphylococcus aureus ATTC 33591.
PRODUCT
1) Smiths Medical Medfusion model 3500 syringe Infusion pump, software
version V3.0.6. Model 3500. Rx Only. Recall # Z-0650-2010;
2) Smiths Medical Medfusion model 3010a syringe Infusion pump. REF
3010A. Rx Only. Recall # Z-0651-2010.
MANUFACTURER: Smiths Medical ASD, Inc., Saint Paul, MN, by letter dated
November 16, 2009. Firm initiated recall is ongoing.
REASON: Smiths Medical has become aware of an increased trend in reports
of Motor Not Running (MNR) and Motor Rate Error (MRE) alarm message
events with certain Medfusion Syringe Infusion Pumps, Models 3010A and
3500 (Pump). MNR/ MRE are high priority alarm messages which can occur
for a variety of reasons as part of the usual self-test functionality of
the Pump. The Pump is designed so that when its software detects a
system fault during routine self-tests, the Pump stops delivery and
provides visual and audible alarms - which include a flashing red
indicator, a display screen backlight that oscillates between bright and
dim, an alarm message on the screen display and a repeating audible
sound to alert the clinician of the situation. The message, Motor Not
Running or Motor Rate Error also displays on the Pump screen during
these alarm message events. If a MNR/ MRE alarm message event occurs
during start up or during infusion, the pump will provide a visual and
audible alarms and the pump will not operate. This is likely to cause an
interruption or delay in therapy for the patient. Smiths Medical is
requiring its customers to return all Pumps with the Serial Numbers
listed in their letters. If a MNR/ MRE alarm message event occurs during
start up or during infusion, the pump will provide a visual and audible
alarms and the pump will not operate.
PRODUCT: Hudson RCI One Way Valve, 22mm E.D. to 22mm O.D., REF 1665, Rx
Only. Recall # Z-0652-2010.
MANUFACTURER: Recalling Firm: Telefelx Medical, Durham, NC, by letters
beginning December 4, 2009. Manufacturer: Teleflex Medical, Tamaulipas,
Mexico. Firm initiated recall is ongoing.
REASON: Incorrect packaging; product code 1664 was incorrectly packaged
as product code 1665. If the red arrows are not followed, the valve may
be placed in the circuit in the wrong orientation for gas flow severe
restriction of patient inspiration or expiration will occur.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of Recalls as of
January 13, 2010
CLASS II
PRODUCT:
1)1) Decathalon 24CM DECATHLON STD KIT Models: DE19SH24 and DE19SH24-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated
tips, cuff and side holes for chronic hemodialysis and apheresis. Recall
# Z-0288-2010;
2) 28CM DECATHLON STD KIT Models: DE23SH28 and DE23SH28-K 15.5 Fr
Polyurethane twin lumen hemodialysis catheter with separated tips, cuff
and side holes for chronic hemodialysis and apheresis. Recall #
Z-0289-2010;
3) 32CM DECATHLON STD KIT Model: DE27SH32 and DE27SH32-K 15.5 Fr
Polyurethane twin lumen hemodialysis catheter with separated tips, cuff
and side holes for chronic hemodialysis and apheresis. Recall #
Z-0290-2010;
4) 36CM DECATHLON STD KIT Models: DE31SH36 and DE31SH36-K 15.5 Fr
Polyurethane twin lumen hemodialysis catheter with separated tips, cuff
and side holes for chronic hemodialysis and apheresis. Kit 28cm
Decathlon Std Kit. Recall # Z-0291-2010;
5) 40CM DECATHLON STD KIT Models: DE35SH40 and DE35SH40-K 15.5 Fr
Polyurethane twin lumen hemodialysis catheter with separated tips, cuff
and side holes for chronic hemodialysis and apheresis. Recall #
Z-0292-2010;
6) 55CM DECATHLON STD KIT Models: DE50SH55 and DE50SH55-K 15.5 Fr
Polyurethane twin lumen hemodialysis catheter with separated tips, cuff
and side holes for chronic hemodialysis and apheresis. Recall #
Z-0293-2010;
7) 24CM DECATHLON FUNNEL TIP STD KIT Model: DF19SH24 DECATHLON FUNNEL
TIP 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated
funnel tips, cuff and side holes for chronic hemodialysis and apheresis.
Kit contains catheter with stylet, 18 gauge introducer needle, 12cc
syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator,
16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free. Recall # Z-0294-2010;
8) 28CM DECATHLON FUNNEL TIP STD KIT Model: DF23SH28 DECATHLON FUNNEL
TIP 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated
funnel tips, cuff and side holes for chronic hemodialysis and apheresis.
Kit contains catheter with stylet, 18 gauge introducer needle, 12cc
syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator,
16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free. Recall # Z-0295-2010;
9) 32CM DECATHLON FUNNEL TIP STD KIT Model: DF27SH32 DECATHLON FUNNEL
TIP 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated
funnel tips, cuff and side holes for chronic hemodialysis and apheresis.
Kit contains catheter with stylet, 18 gauge introducer needle, 12cc
syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator,
16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free. Recall # Z-0296-2010;
10) 36CM DECATHLON FUNNEL TIP STD KIT Model: DF31SH36 DECATHLON FUNNEL
TIP 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated
funnel tips, cuff and side holes for chronic hemodialysis and apheresis.
Kit contains catheter with stylet, 18 gauge introducer needle, 12cc
syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator,
16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free Recall # Z-0297-2010;
11) 40CM DECATHLON FUNNEL TIP STD KIT Model: DF35SH40 DECATHLON FUNNEL
TIP 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated
funnel tips, cuff and side holes for chronic hemodialysis and apheresis.
Kit contains catheter with stylet, 18 gauge introducer needle, 12cc
syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator,
16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free. Recall # Z-0298-2010;
12) 55CM DECATHLON FUNNEL TIP STD KIT Model: DF50SH55 DECATHLON FUNNEL
TIP 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated
funnel tips, cuff and side holes for chronic hemodialysis and apheresis.
Kit contains catheter with stylet, 18 gauge introducer needle, 12cc
syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator,
16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free. Recall # Z-0299-2010;
13) 24CM DECATHLON FUNNEL TIP CATHETER Model: DF19SH24-100 DECATHLON
FUNNEL TIP - CATHETER ONLY 15.5 Fr polyurethane twin lumen hemodialysis
catheter with separated tips, cuff and side holes for chronic
hemodialysis and apheresis. Latex free. Recall # Z-0300-2010;
14) 28CM DECATHLON FUNNEL TIP CATHETER Model: DF23SH28-100 DECATHLON
FUNNEL TIP - CATHETER ONLY 15.5 Fr polyurethane twin lumen hemodialysis
catheter with separated tips, cuff and side holes for chronic
hemodialysis and apheresis. Latex free. Recall # -0301-2010;
15) 32CM DECATHLON FUNNEL TIP CATHETER Model: DF27SH32-100 DECATHLON
FUNNEL TIP - CATHETER ONLY 15.5 Fr polyurethane twin lumen hemodialysis
catheter with separated tips, cuff and side holes for chronic
hemodialysis and apheresis. Latex free. Recall # Z-0302-2010;
16) 24CM DECATHLON MINI KIT Model: DM19SH24 DECATHLON MINI KIT 15.5 Fr
polyurethane twin lumen hemodialysis catheter with separated tips, cuff
and side holes for chronic hemodialysis and apheresis. Kit contains
catheter, 18 gauge introducer needle, 16 Fr valved peel-away sheath
dilator, tunneling stylet, (2) injection sealing caps, and warning
label. Latex free. Recall # Z-0303-2010;
17) 28CM DECATHLON MINI KIT Model : DM23SH28 DECATHLON MINI KIT 15.5 Fr
polyurethane twin lumen hemodialysis catheter with separated tips, cuff
and side holes for chronic hemodialysis and apheresis. Kit contains
catheter, 18 gauge introducer needle, 16 Fr valved peel-away sheath
dilator, tunneling stylet, (2) injection sealing caps, and warning
label. Latex free. Recall # Z-0304-2010;
18) 32CM DECATHLON MINI KIT Model: DM27SH32 DECATHLON MINI KIT 15.5 Fr
polyurethane twin lumen hemodialysis catheter with separated tips, cuff
and side holes for chronic hemodialysis and apheresis. Kit contains
catheter, 18 gauge intro. Recall # Z-0305-2010;
19) 24CM DECATHLON EXCHANGE KIT Model: DX19SH24-XP DECATHLON MINI KIT
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated
tips, cuff and side holes for chronic hemodialysis and apheresis. Kit
contains catheter, 18 gauge introducer needle, 16 Fr valved peel-away
sheath dilator, tunneling stylet, (2) injection sealing caps, and
warning label. Latex free. Recall # Z-0306-2010;
20) 28CM DECATHLON EXCHANGE KIT Model: DX23SH28-XP DECATHLON MINI KIT
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated
tips, cuff and side holes for chronic hemodialysis and apheresis. Kit
contains catheter, 18 gauge introducer needle, 16 Fr valved peel-away
sheath dilator, tunneling stylet, (2) injection sealing caps, and
warning label. Latex free. Recall # Z-0307-2010;
21) 32CM DECATHLON EXCHANGE KIT Model: DX27SH32-XP DECATHLON MINI KIT
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated
tips, cuff and side holes for chronic hemodialysis and apheresis. Kit
contains catheter, 18 gauge introducer needle, 16 Fr valved peel-away
sheath dilator, tunneling stylet, (2) injection sealing caps, and
warning label. Latex free. Recall # Z-0308-2010;
22) 24CM DECATHLON GOLD STD KIT Models: DEC19SH24 and DEC19SH24-K
DECATHLON GOLD 15.5 Fr polyurethane twin lumen Heparin coated
hemodialysis catheter with separated tips, cuff and side holes for
chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge
introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr
dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel,
tunneling stylet, (4) gauze sponges, wound dressing, (2) injection
sealing caps, and warning label. Latex free. Recall # Z-0309-2010;
23). 28CM DECATHLON GOLD STD KIT Model: DEC23SH28 and DEC23SH28-K.
Recall # Z-0310-2010;
24) 32CM DECATHLON GOLD STD KIT Models: DEC27SH32 and DEC27SH32-K
DECATHLON GOLD 15.5 Fr polyurethane twin lumen Heparin coated
hemodialysis catheter with separated tips, cuff and side holes for
chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge
introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr
dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel,
tunneling stylet, (4) gauze sponges, wound dressing, (2) injection
sealing caps, and warning label. Latex free. Recall # Z-0311-2010;
25) 36CM DECATHLON GOLD STD KIT Model: DEC31SH36 and DEC31SH36-K
DECATHLON GOLD 15.5 Fr polyurethane twin lumen Heparin coated
hemodialysis catheter with separated tips, cuff and side holes for
chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge
introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr
dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel,
tunneling stylet, (4) gauze sponges, wound dressing, (2) injection
sealing caps, and warning label. Latex free. Recall # Z-0312-2010;
26) 40CM DECATHLON GOLD STD KIT Model: DEC35SH40 and DEC35SH40-K
DECATHLON GOLD 15.5 Fr polyurethane twin lumen Heparin coated
hemodialysis catheter with separated tips, cuff and side holes for
chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge
introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr
dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel,
tunneling stylet, (4) gauze sponges, wound dressing, (2) injection
sealing caps, and warning label. Latex free. Recall # Z-0313-2010;
27) 55CM DECATHLON GOLD STD KIT Models: DEC50SH55 and DEC50SH55-K
DECATHLON GOLD 15.5 Fr polyurethane twin lumen Heparin coated
hemodialysis catheter with separated tips, cuff and side holes for
chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge
introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr
dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel,
tunneling stylet, (4) gauze sponges, wound dressing, (2) injection
sealing caps, and warning label. Latex free. Recall # Z-0314-2010;
28) 24CM DECATHLON GOLD FUNNEL TIP STD KIT Models: DFC19SH24 and
DFC19SH24-K DECATHLON GOLD FUNNEL TIP 15.5 Fr polyurethane twin lumen
Heparin coated hemodialysis catheter with separated funnel tips, cuff
and side holes for chronic hemodialysis and apheresis. Kit contains
catheter with stylet, 18 gauge introducer needle, 12cc syringe,
J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr
peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free. Recall # Z-0315-2010;
29) 28CM DECATHLON GOLD FUNNEL TIP STD KIT Models: DFC23SH28 and
DFC23SH28-K DECATHLON GOLD FUNNEL TIP 15.5 Fr polyurethane twin lumen
Heparin coated hemodialysis catheter with separated funnel tips, cuff
and side holes for chronic hemodialysis and apheresis. Kit contains
catheter with stylet, 18 gauge introducer needle, 12cc syringe,
J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr
peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free. Recall # Z-0316-2010;
30) 32CM DECATHLON GOLD FUNNEL TIP STD KIT Model: DFC27SH32 15.5 Fr
polyurethane twin lumen Heparin coated hemodialysis catheter with
separated funnel tips, cuff and side holes for chronic hemodialysis and
apheresis. Kit contains catheter with stylet, 18 gauge introducer
needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator,
14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling
stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps,
and warning label. Latex free. Recall # Z-0317-2010;
31) 24CM ALTA LR STANDARD KIT High Flow Recirculation Catheter Model:
AL19SH24 ALTA CATHETER WITH SIDE HOLES 15.5 Fr polyurethane twin lumen
fixed tip hemodialysis catheter, cuff and side holes for chronic
hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer
needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire,
12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11
scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2)
injection sealing caps, and warning label. Latex free. Recall #
Z-0318-2010;
32) 28CM ALTA LR STANDARD KIT High Flow Recirculation Model: AL23SH28
ALTA CATHETER WITH SIDE HOLES 15.5 Fr polyurethane twin lumen fixed tip
hemodialysis catheter, cuff and side holes for chronic hemodialysis and
apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc
syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator,
14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel,
tunneling stylet, (4) gauze sponges, wound dressing, (2) injection
sealing caps, and warning label. Latex free. Recall # Z-0319-2010;
33) 32CM ALTA LR STANDARD KIT Model: AL27SH32 ALTA CATHETER WITH SIDE
HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter,
cuff and side holes for chronic hemodialysis and apheresis. Kit contains
catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038
inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved
peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free. Recall # Z-0320-2010;
34) 36CM ALTA LR STANDARD KIT Model: AL31SH36 ALTA CATHETER WITH SIDE
HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter,
cuff and side holes for chronic hemodialysis and apheresis. Kit contains
catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038
inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved
peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free. Recall # Z-0321-2010;
35) 40CM ALTA LR STANDARD KIT Model: AL35SH40 ALTA CATHETER WITH SIDE
HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter,
cuff and side holes for chronic hemodialysis and apheresis. Kit contains
catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038
inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved
peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free. Recall # Z-0322-2010;
36) 24CM ALTA LR STANDARD KIT Model: AL19NH24 ALTA CATHETER WITH NO SIDE
HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter,
cuff, and no side holes for chronic hemodialysis and apheresis. Kit
contains catheter, 18 gauge introducer needle,12cc syringe, J/straight
0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr
valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4)
gauze sponges, wound dressing, (2) injection sealing caps, and warning
label. Latex free. Recall # Z-0323-2010;
37) 28CM ALTA LR STANDARD KIT Model: AL23NH28 ALTA CATHETER WITH NO SIDE
HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter,
cuff, and no side holes for chronic hemodialysis and apheresis. Kit
contains catheter, 18 gauge introducer needle,12cc syringe, J/straight
0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr
valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4)
gauze sponges, wound dressing, (2) injection sealing caps, and warning
label. Latex free. Recall # Z-0324-2010;
38) 32CM ALTA LR STANDARD KIT Model: AL27NH32 ALTA CATHETER WITH NO SIDE
HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter,
cuff, and no side holes for chronic hemodialysis and apheresis. Kit
contains catheter, 18 gauge introducer needle,12cc syringe, J/straight
0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr
valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4)
gauze sponges, wound dressing, (2) injection sealing caps, and warning
label. Latex free. Recall # Z-0325-2010;
39) 36CM ALTA LR STANDARD KIT Model: AL31NH36 ALTA CATHETER WITH NO SIDE
HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter,
cuff, and no side holes for chronic hemodialysis and apheresis. Kit
contains catheter, 18 gauge introducer needle,12cc syringe, J/straight
0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr
valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4)
gauze sponges, wound dressing, (2) injection sealing caps, and warning
label. Latex free. Recall # Z-0326-2010;
40) 24CM ALTA EXCHANGE KIT Model: AL19SH24-XP ALTA EXCHANGE KIT 15.5 Fr
polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side
holes for chronic hemodialysis and apheresis. Latex free. Recall #
Z-0327-2010;
41) 28CM ALTA EXCHANGE KIT Model: AL23SH28XP ALTA EXCHANGE KIT 15.5 Fr
polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side
holes for chronic hemodialysis and apheresis. Latex free. Recall #
Z-0328-2010;
42) 32CM ALTA EXCHANGE Model: AL27SH32XP ALTA EXCHANGE KIT 15.5 Fr
polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side
holes for chronic hemodialysis and apheresis. Latex free. Recall #
Z-0329-2010;
43) 24CM ALTA LR GOLD STD KIT Model: ALC19SH24 ALTA GOLD 15.5 Fr
polyurethane twin lumen fixed tip heparin coated hemodialysis catheter,
cuff and side holes for chronic hemodialysis and apheresis. Kit contains
catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038
inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved
peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free. Recall # Z-0330-2010;
44) 28CM ALTA LR GOLD STD KIT Model: ALC23SH28 ALTA GOLD 15.5 Fr
polyurethane twin lumen fixed tip heparin coated hemodialysis catheter,
cuff and side holes for chronic hemodialysis and apheresis. Kit contains
catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038
inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved
peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free. Recall # Z-0331-2010;
45) 32CM ALTA LR GOLD STD KIT Model: ALC27SH32 ALTA GOLD 15.5 Fr
polyurethane twin lumen fixed tip heparin coated hemodialysis catheter,
cuff and side holes for chronic hemodialysis and apheresis. Kit contains
catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038
inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved
peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free. Recall # Z-0332-2010;
46) 36CM ALTA LR GOLD STD KIT Model: ALC31SH36 ALTA GOLD 15.5 Fr
polyurethane twin lumen fixed tip heparin coated hemodialysis catheter,
cuff and side holes for chronic hemodialysis and apheresis. Kit contains
catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038
inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved
peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free. Recall # Z-0333-2010;
47) 40CM ALTA LR GOLD STD KIT Model: ALC35SH40 ALTA GOLD 15.5 Fr
polyurethane twin lumen fixed tip heparin coated hemodialysis catheter,
cuff and side holes for chronic hemodialysis and apheresis. Kit contains
catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038
inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved
peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free. Recall # Z-0334-2010;
48) 55CM ALTA LR GOLD STD KIT Model: ALC50SH55 ALTA GOLD 15.5 Fr
polyurethane twin lumen fixed tip heparin coated hemodialysis catheter,
cuff and side holes for chronic hemodialysis and apheresis. Kit contains
catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038
inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved
peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze
sponges, wound dressing, (2) injection sealing caps, and warning label.
Latex free. Recall # Z-0335-2010
MANUFACTURER: Spire Biomedical, Inc., Bedford, MA, by letter dated
October 22, 2009. Firm initiated recall is ongoing.r>
REASON: There is a possibility that the catheter tubing could separate
from the hub/bifurcation of the device. If this occurs, bleeding is the
primary clinical complication likely to result from catheter tubing/hub
separation. A second potential clinical complication is air embolism,
particularly for the segment of the patient population that develops
negative central venous pressure during normal respiration.
PRODUCT:
1)1) System Storage Cart, product code CART; SurgASSIST Service Manual,
product code SRVM; SurgASSIST System Starter Kit, product code Surg200;
SurgASSIST System with Integrated Controls, product code Surg300;
Operator Manual, product code OPMA. Recall # Z-0392-2010;
2) Circular Stapler 21 mm Digital Loading Unit, product code CS21;
Circular Stapler 25 mm Digital Loading Unit, product code CS25; Circular
Stapler 29 mm Digital Loading Unit, product code CS29; Circular Stapler
33 mm Digital Loading Unit, product code CS33. Recall # Z-0393-2010;
3) Right Angle Linear Cutter, 30 mm Digital Loading Unit, product code
RALC30; Right Angle Linear Cutter, 30 mm Vascular Digital Loading Unit,
product code RALC30V; Right Angle Linear Cutter, 45 mm Digital Loading
Unit, product code RALC45. Recall # Z-0394-2010;
4) Remote Control Unit with Wire, product code RCW100. Recall #
Z-0395-2010;
5) Straight Linear Cutter 55 mm Blue Digital Loading Unit, product code
SLC55B; Straight Linear Cutter 55 mm Green Digital Loading Unit, product
code SLC55G; Straight Linear Cutter 55 mm Blue Reload, product code
SLCR55B; Straight Linear Cutter 55 mm Green Reload, product code
SLCR55G; Straight Linear 4 Row No Knife Digital Loading Unit, product
code SLS55B4. Recall # Z-0396-2010;
6) FlexShaft, product code FS14; FlexShaft II, product code FS214;
FlexShaft III, product code FS312; FlexShaft III Sterilization Connector
Guard, product code FS3SCG; FlexShaft II Reconditioned, product code
FS214RC; Manual Release for FlexShaft II & III, product code MR14.
Recall # Z-0397-2010;
7) Power Linear Cutter 75 mm, Reusable Digital Loading Unit, product
code PLC75; Power Linear Cutter Reload, 75 mm Blue, product code
PLCR75B; Power Linear Cutter Reload, 75 mm Green, product code PLCR75G.
Recall # Z-0398-2010;
8) Power Extender Straight, product code PES100; Power Extender Straight
Reconditioned, product code PES100RC; Power Extender Curved with
Integrated Controls Reconditioned, product code PEC200RC; Power Extender
Straight with Integrated Controls Reconditioned, product code PES200RC.
Recall # Z-0399-2010;
9) Endoscopic Linear Cutter Reload, 45 mm Blue, product code PLCR45B;
Endoscopic Linear Cutter Reload, 45 mm Green, product code PLCR45G;
Reusable Endoscopic Linear Cutter, 60 mm, product code PLC60; Endoscopic
Linear Cutter Reload, 60 mm Blue, product code PLCR60B; Endoscopic
Linear Cutter Reload, 60 mm Green, product code PLCR60G; Endoscopic
Linear Cutter Reload, 60 mm Green Thoracic, product code PLCR60GT;
Reusable Endoscopic Linear Cutter, 60 mm Reconditioned, product code
PLC60RC. Recall # Z-0400-2010;
10) Power Circular Stapler 21 mm Digital Loading Unit, product code
PCS21; Power Circular Stapler 29 mm Digital Loading Unit, product code
PCS29. Recall # Z-0401-2010;
11) Power Console, product code PC100; Power Console System, product
code PC100S; Power Console Reconditioned, product code PC100RC. Recall #
Z-0402-2010;
12) Sterile Sheath, product code SS01. Recall # Z-0403-2010;
13) Program Memory Card, product code MCV1A. Recall # Z-0404-2010;
14) Intelligent Reload, 45 mm Blue, product code iR45B; Intelligent
Reload, 45 mm Green, product code iR45G; Intelligent Reload Mid Cut 45mm
Blue, product code iR45MB; Intelligent Reload Mid Cut 45mm Green,
product code iR45MG; Intelligent Reload, 45 mm, Vascular, product code
iR45V; Intelligent Reload, 60 mm Blue, product code iR60B; Intelligent
Reload, 60 mm Green, product code iR60G; Intelligent Reload Mid Cut 60mm
Blue, product code iR60MB; Intelligent Reload Mid Cut 60mm Green,
product code iR60MG; Intelligent Reload, 60 mm Blue No Knife, product
code iR60B4. Recall # Z-0405-2010;
15) Intelligent Delivery System, Straight, product code iDriveS;
Intelligent Delivery System, Curved, product code iDriveC; Intelligent
Delivery System, Flexible, product code iDriveF. Recall # Z-0406-2010;
16) Intelligent 60mm Straight Endoscopic Linear Cutter, product code
i60S; Intelligent 60mm Straight Endoscopic Linear Cutter Reconditioned,
product code i60SRC. Recall # Z-0407-2010;
17) Intelligent 60mm Articulating Endoscopic Linear Cutter, product code
i60; Intelligent 60mm Articulating Endoscopic Linear Cutter Extra Long,
product code i60XXL; Intelligent 45mm Articulating Endoscopic Linear
Cutter, product code i45; Intelligent 45mm Articulating Endoscopic
Linear Cutter, Vascular, product code i45V. Recall # Z-0408-2010;
18) Intelligent Battery Pack, product code iB100; Intelligent Battery
Charger and Power Supply, product code iB1C1; Intelligent Battery
Insertion Guide, product code iBIG-1; Intelligent Battery Insertion
Tool, product code iBIT-1. Recall # Z-0409-2010;
19) Rigid Curved Positioner, product code RCP; Rigid Curved Positioner
O-Ring, product code RCPOR. Recall # Z-0410-2010;
20) Device Sterilization Tray, product code T300. Recall # Z-0411-2010;
21) Power Supply -not sold separately, product code PWSP; Power Cord -
Not sold separately, product code PWCD. Recall # Z-0412-2010
MANUFACTURER: Recalling Firm: Surgical Devices/Covidien, North Haven,
CT, by letter dated September 23, 2009. Manufacturer: Power Medical
Interventions, Inc., Langhorne, PA. Firm initiated recall is ongoing.
REASON: Lack of assurance that products were manufactured under GMPs.
This action is being undertaken due to certain products potentially
exhibiting compromised staple formation or cutting which in some
instances may result in extended surgical time for the patient.p>
PRODUCT: Medtronic Accessory Kit, Titan Anchor Accessory Kit, 3550-39,
Single Use, RX Only, Contents of the inner packages are Sterile. Recall
# Z-500-2010
MAMANUFACTURER: Recalling Firm: Medtronic Neuromodulation, Minneapolis,
MN, by letter on October 27, 2009. Manufacturer: Medtronic
Neuromodlation, Columbia Heights, MN. Firm initiated recall is ongoing.
REASON: Medtronic is issuing a medical device correction for the Model
3550-39 Titan anchor due to the potential for lead migration as a result
of insert separation within the anchor. The Medtronic Model 3550-39
Titan anchor accessory kit is designed for use with Medtronic
percutaneous in-line connector spinal cord stimulation leads. Medtronic
has received reports of separation of the titanium insert from the
silicone body of the anchor.
PRODUCT: IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation
Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA
and Esophageal Catheter. The Impact catheter is packaged in a straight
sheath and then heat sealed in two Tyvek pouches. The inner pouch is the
one that is deteriorating when exposed to the sunlight. The outer pouch
retains its seal so the sterility is not compromised. --- 510 K931009 -
Device Listing #D003206 and 510 K983373 - Device Listing # D003212.
Recall # Z-0509-2010.
MANUFACTURER: Recalling Firm: Numed Inc., Hopkinton, NY, by e-mail and
letter dated September 24, 2009. Manufacturers: Numed Inc., Hopkinton,
NY, and Mangar Industries In., New Britain, PA. Firm initiated recall is
ongoing.
REASON: The firm received a complaint from the sole direct account that
while performing an inventory review it was observed that the packaging
of the IMPACT catheter was cracked and deteriorating. The product was
still in its packaging and never used. The customer referred to it as
looking like "paint crackle." The risk is that for continued sterility
to be assured, the packaging must remain intact.
PRODUCT: 1) Repose G2 Bone Screw System, Sterile, REF 76353200; The
Repose G@ Bone Screw System is composed of the Repose Bone Screw (a
miniature, self-tapping screw attached to polypropylene suture), the
Repose Bone Screw Inserter (a battery operated, disposable device that
deploys the screw), the Repose Suture Passer, and the Repose Tongue
Retractor. Recall # Z-0535-2010; 2) Repose G2 Bone Screw, Sterile, REF
76310200. Recall # Z-0536-2010.
MANUFACTURER: Medtronic Xomed, Inc., Jacksonville, FL, by telephone on
July 27, 2009. Firm initiated recall is ongoing.
REASON: Product recall due to improper labeling.
PRODUCT: GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8
Expert Diagnostic Ultrasound Systems. Recall # Z-0541-2010
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesh, WI, by
letters dated October 22, 2009. Manufacturer: GE Medical Systems,
Kretziechnik GmbH & Co OHG, Zipf, Austria. Firm initiated recall is
ongoing.
REASON: GE Healthcare has recently become aware of an incorrect
operating procedure associated with software versions 9.0.0, 9.0.1, and
9.0.2 of the Voluson E6 or Voluson E8 Diagnostic Ultrasound Systems that
may impact patient safety. When using the combination of 2D-CRI and PW
with a steered Doppler angle, the displayed velocity scale is incorrect.
The consequence can be an underestimation of flow velocities in the
range of 30-60%. This operating procedure is typically used for
quantification of carotid stenosis. The degree of the stenosis may be
inaccurately quantified which may result in a delay in treatment.
PRODUCT: Polycarbonate prescription lenses (single vision, progressive,
and trifocal). Recall # Z-0542-2010.r>
MANUFACTURER: Recalling Firm: Luxottica, Mason, OH, by letters on
November 24, 2009. Firm initiated recall is ongoing.
REREASON: The lenses made for sunglass frames (Liberty Sport Slam or
MaxMorpheus) do not meet the lens thickness specification established by
the frame manufacturer. The lens thickness range from 1.0 to 1.9
millimeters instead of the required 2.0 millimeter minimum. There is a
potential risk that the lenses could break or disengage from the frame
in the event of an impact.
PRODUCT:
1) Philips Avalon Fetal Monitor FM 20, Catalog Number: M2702A. Recall #
Z-0549-2010;
2) Philips Avalon Fetal Monitor FM 30, Catalog Number: M2703A. Recall #
Z-0550-2010;
3) Philips Avalon Fetal Monitor FM 40, Catalog Number: M2704A. Recall #
Z-0551-2010;
4) Philips Avalon Fetal Monitor FM 50, Catalog Number: M2705A. Recall #
Z-0552-2010
MANUFACTURER: Philips Healthcare Inc., Andover MA, by letter on November
23, 2009. Firm initiated recall is ongoing.
REASON: Potential for inaccurate ultra-sound derived fetal heart rate
readings in Philips Avalon Fetal Monitors. Although the types of
inaccuracies described in these complaints reflect known limitations
inherent to ultrasound fetal heart rate monitoring, the frequency of
such complaints is greater for these devices than for the previous
generation Philips Series 50 fetal monitors. Clinical decisions based on
unrecognized inaccuracies in fetal heart traces may lead health care
professionals to: Perform unnecessary interventions, such as cesarean
delivery; Fail to identify the need for interventions; or Fail to
identify fetal distress.
PRODUCT: Bausch & Lomb Boston Conditioning Solution, Original Formula.
The product is packed in 1 fl oz (30 mL), 3 fl oz (90 mL), 3.5 fl oz
(105 mL) and 4 fl oz (120 ml) bottles. Recall # Z-0553-2010
MANUFACTURER: Recalling Firm: Bausch & Lomb Inc., Rochester, NY, by
letter on/about November 6, 2009. Manufacturer: Bausch & Lomb Inc.,
Greenville, SC. Firm initiated recall is ongoing.
REASON: The product failed to meet Out of Specification shelf life at
the 9 months time point.
PRODUCT:
1) AccuSure, U-100 28 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short
Needle, packaged 10 syringes per package, 10 packages per carton, NDC
0603-6995-21. The device is intended to be used as an insulin syringe.
Recall # Z-0569-2010;
2) AccuSure, U-100 28 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short
Needle, packaged 10 syringes per package, 10 packages per carton, NDC
0603-6996-21. Recall # Z-0570-2010;
3) AccuSure, U-100 29 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short
Needle, packaged 10 syringes per package, 10 packages per carton, NDC
0603-6997-21. Recall # Z-0571-2010;
4) AccuSure, U-100 29 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short
Needle, packaged 10 syringes per package, 10 packages per carton, NDC
0603-6998-21. Recall # Z-0572-2010;
5) AccuSure, U-100 30 Gauge, 1/2cc Insulin Syringe, 5/16" (8mm) Needles,
Short Needle, packaged 10 syringes per package, 10 packages per carton,
NDC 0603-6999-21. Recall # Z-0573-2010;
6) AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles,
Short Needle, packaged 10 syringes per package, 10 packages per carton,
NDC 0603-7000-21. Recall # Z-0574-2010;
7) AccuSure, U-100 31 Gauge, 1/2cc Insulin Syringe, 5/16" (8mm) Needles,
Short Needle, packaged 10 syringes per package, 10 packages per carton,
NDC 0603-7001-21. Recall # Z-0575-2010;
8) AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles,
Short Needle, packaged 10 syringes per package, 10 packages per carton,
NDC 0603-7002-21. Recall # Z-0576-2010
MANUFACTURER: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals,
Huntsville, AL, by press release on October 27, 2009 and by letter on
October 30, 2009. Firm initiated recall is ongoing.
REASON: Needles are becoming dislodged from the barrels.p>
PRODUCT: Invacare Storm TDX SR Power Wheelchair with Stability Lock,
Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG,
TDXSR-MCG-HD, TDXSRV-HD. Recall # Z-0579-2010.
MANUFACTURER: Invacare Corp., Elyria, OH, by letter on September 15,
2009. Firm initiated recall is ongoing.
REASON: For some Invacare chairs, the stability lock feature may not be
engaging properly or consistently. If the stability lock feature does
not engage properly, the wheelchair may do one or more of the following:
(1) veer to one side; (2) rock forward onto its front riggings; (3)
drive in an unintended circular motion; and/or (4) fall forward or to
one side. In these cases there is a risk to injury for the user.
PRODUCT:
1)1) Enpath Lead Adaptor, Ref: 501214. The contents of the inner package
have been sterilized by ethylene-oxide gas. Recall # Z-0580-2010;
2) Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. The
contents of the inner package have been sterilized by ethylene-oxide
gas. Recall # Z-0581-2010
MANUFACTURER: Greatbatch Medical, Minneapolis, MN, by telephone
beginning September 1, 2009. Firm initiated recall is complete.
REASON: The silicone tubing of affected leads was processed outside of
validated parameters. Although the material remains biocompatible, test
data regarding the performance characteristics are not available.
PRODUCT: Oxygen Sensor, Catalog number: 5804. Recall # Z-0585-2010
MANUFACTURER: Recalling Firm: Teleflex Medical, Durham, NC, by letters
on or about November 25, 2009. Manufacturer: Sensidyne, Inc.,
Clearwater, FL. Firm initiated recall is ongoing.
REASON: Sensor causes the oxygen monitor to display prematurely a Low
Sensor warning which indicates an early maintenance requirement for the
instrument. This may result in interrupted treatment.p>
PRPRODUCT: BD 30 ml Syringe; Luer-Lok Tip Catalog # 309650. Recall #
Z-0586-2010
MANUFACTURER: Recalling Firm: Becton Dickinson & Co., Franklin Lakes,
NJ, by letters on November 23, 2009 and December 8, 2009. Manufacturer:
BD Medical - Medical Surgical, Columbus, NB. Firm initiated recall is
ongoing.
REASON: Reports received of open seals.
PRODUCT: 1) Powerlink System with IntuiTrak Delivery System
(Endovascular Graft): Model Number 34-34-80L. Recall # Z-0593-2010; 2)
Powerlink System with IntuiTrak Delivery System (Endovascular Graft):
Model Number 34-34-80LE. Recall # Z-0594-2010.
MANUFACTURER: Endologix Inc., Irvine, CA, by telephone and letter on
November 25, 2009. Firm initiated recall is ongoing.
REASON The product has the potential for the polyimide tubing to detach
from the inner core due to the bond failure. If this occurs, it is
likely that treatment will be interrupted. The firm's initial health
hazard analysis indicated the event may cause temporary or medically
reversible adverse health consequences or an outcome where the
probability of serious adverse health consequences is remote.
PRODUCT
1) Stryker MIS Bur, 2.0mm Neuro Diamond, sterile; REF 8420-107-120.
Recall # Z-0595-2010;
2) Stryker MIS Bur, 2.5mm Neuro Diamond, sterile; REF 8420-107-125.
Recall # Z-0596-2010;
3) Stryker MIS Bur, 3.0mm Neuro Diamond, sterile; REF 8420-107-130.
Recall # Z-0597-2010;
4) Stryker MIS Bur, 3.5mm Neuro Diamond, sterile; REF 8420-107-135.
Recall # Z-0598-2010;
5) Stryker MIS Bur, 3.0mm Neuro Diamond Course, sterile; REF
8420-107-230. Recall # Z-0599-2010
MANUFACTURER: Recalling Firm: Stryker Instruments Div. of Stryker Corp.,
Kalamazoo, MI, by letters dated July 10, 2009 and July 13, 2009.
Manufacturer: Stryker Ireland, LTD, Instruments Div., Carrigtwohill, Co.
Cork, Ireland. Firm initiated recall is ongoing.
REASON: The bur may fracture, resulting in fragments within the surgical
site, injury to the patient or surgical team, or both.
PRODUCT: AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00). Recall #
Z-0605-2010
MANUFACTURER: Recalling Firm: Abbott Medical Optics Inc (AMO), Santa
Ana, CA, by letters beginning November 6, 2009 and November 9,
2009.Manufacturer: AMO Puerto Rico Manufacturing, Inc., Anasco, PR. Firm
initiated recall is on going.
REASON: Some Tecnis 1-Piece IOLs (model ZCB00) have adhered to the lens
optic after insertion into the eye. This can lead to a need for
additional manipulation to separate the haptics from the optic during
surgery which could lead to an injury.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of Recalls as of January 6, 2010:
CLASS II
PRODUCT:
1)1) Siemens Biograph mCt-X, model number 10248670. Medical Imaging
Equipment. Recall # Z-0162-2010;
2) Siemens Biograph mCT-S 40, model number 10248671. Medical Imaging
Equipment. Recall # Z-0163-2010;
3) Siemens Biograph mCT-S 64, model number 10248672. Medical Imaging
Equipment. Recall # Z-0164-2010
MANUFACTURER: Siemens Medical Solutions USA Inc., Knoxville, TN, by
letter dated September 3, 2009. Firm initiated recall is ongoing.
REASON: In the unlikely event that the device is modified to operate in
the tilted position, the telescoping support mechanism will not engage
properly.
PRODUCT: Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7
m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2
injection Y-sites, 3 Luer Activated Valves and Male Luer Lock Adapter
with Retractable Collar; 48 individually pouched sterile sets per case.
A sterile fluid pathway used to administer fluids from a container to a
patient's vascular system through a vascular access device. Product code
2C8864. Recall # Z-0487-2010
MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL,
letter dated November 3, 2009. Manufacturer: Baxter Healthcare
Corporation of Puerto Rico S.A., Aibonito, PR. Firm initiated recall is
ongoing.
REASON: The tubing may separate from the distal Clearlink Y-site of the
set, which could result in patient injury if the separation occurs
during patient use.
PRODUCT: r>
1) Lactosorb System 2.0MM Adjustable Self-Drilling Tap, REF: 915-2075,
Non-Sterile Product. Lacto Sorb Self Drilling Taps are used to drill and
tap holes. They are self drilling so they do not require a hole to be
drilled prior to use. They are used along with the Lacto SorbBulbs
Handles or Power Drivers to advance the Tap into the bone. Recall #
Z-0489-2010;
2) Lactosorb System 1.5MM Adjustable Self-Drilling Tap for Power Driver,
REF: 915-2185, Non-Sterile Product, LactoSorb Self Drilling Taps are
used to drill and tap holes. They are self drilling so they do not
require a hole to be drilled prior to use. They are used along with the
LactoSorb Bulbs Handles or Power Drivers to advance the Tap into the
bone. Recall # Z-0490-2010
MANUFACTURER: Biomet Microfixation, Inc., Jacksonville, FL, by telephone
and e-mail beginning September 2009. Firm initiated recall is ongoing.
REASON: Biomet Microfixation is recalling LactoSorb Self Drilling
Adjustable Tap Model Numbers 915-2075 Lot # 064350 and 915-2185 Lot #
885580. The two lots identified have a new style stop and an old style
tap; they are not compatible, as the depth etchings do not line up
correctly. Depending on the tap (1.5mm VS 2.0mm) you may drill too
shallow or too deep.
PRODUCT: GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular
Imaging Systems. Indicated for use in generating fluoroscopic images of
human anatomy for vascular angiography, diagnostic and interventional
procedures, and optionally, rotational angiography procedures. They are
also indicated for generating fluoroscopic images of human anatomy for
cardiology, diagnostic, and interventional procedures. Recall #
Z-0540-2010
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by
letter dated October 14, 2009. Manufacturer: GE Medical Systems, SCS,
Buc Cedex, France. Firm initiated recall is ongoing.
REASON: GE Healthcare has become aware of a potential limit switch
failure with Innova 2121IQ and 3131IQ (Biplane) systems that may impact
patient safety. A potential limit switch failure could occur due to
collision between the lateral plane of Innova Positioner and other
equipment in the room. This collision may break the x-ray and
positioning switches, and may not allow exam completion. To date, no
injury has been reported related to this condition.
PRODUCT: i-Cat Classic, 3D Dental Imaging System manufactured by
Imaging Sciences International, Hatfield, PA. To be used whenever a
dentist, oral surgeon or other physician needs 3D information of high
contrast objects. Recall # Z-0543-2010
MANUFACTURER: Imaging Sciences International, LLC, Hatfield, PA, by
letter dated October 30, 2009. Firm initiated recall is ongoing.
REASON: Overhead carriage drops quickly.
PRODUCT:
1)1) Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in
8 piece shelf boxes, and convenience kits with single pump units.
Indicated as extracorporeal blood pumps for use in cardiopulmonary
bypass procedures lasting up to 6-hours. Recall # Z-0544-2010;
2) Sarns Centrifugal Pump (without X-coating), catalog 164275, packaged
in 8 piece shelf boxes, and convenience kits with single pump units.
Indicated as extracorporeal blood pumps for use in cardiopulmonary
bypass procedures lasting up to 6-hours. Recall # Z-0545-2010
MANUFACTURER: Recalling Firm: Terumo Cardiovascular Systems Corp., Ann
Arbor, MI, by letter on July 06, 2009. Manufacturer: Terumo
Cardiovascular Corp., Elkton, MD. Firm initiated recall is ongoing.
REASON: The tubing- to- pump connection in a medical device used in
surgical procedures may disengage resulting in blood loss.
PRODUCT: Medtronic Midas Rex Legend Footed Attachment, AF01. Intended
for use with all Legend and Legend EHS motors for general surgery
including maxillofacial, craniofacial and sternotomy applications.
Recall # Z-0546-2010
MANUFACTURER: Medtronic Sofamor Danek Usa, Inc - Dallas Distribution,
Fort Worth, TX, by letter dated November 30, 2009. Firm initiated recall
is ongoing.
REASON: Component of product attachment may be outside established
tolerance with potential for footed portion to break during normal use.
PRODUCT: Vascular Solutions Pronto-Short Extraction Catheter. Model
5030. The PRONTO-Short Extraction catheter is a dual lumen,
over-the-wire (OTW) catheter with related accessories. The catheter is
designed to be delivered through a 6F or larger introducer sheath over
the included 0.018" (0.45mm) guidewire. Sterilized with ethylene oxide.
Recall # Z-0547-2010
MANUFACTURER: Vascular Solutions, Inc., Maple Grove, MN, by letter dated
November 20, 2009. Firm initiated recall is ongoing.
REASON: It was found that three Pronto Short (model 5030) device lots
were manufactured and labeled with an expiration date which is
inconsistent than the expiration of the included guidewire component.
The guidewire is sterilized separately and was realized to have an
expiration date of October 31, 2009.
PRODUCT: Hill-Rom Affinity Four Birthing Bed; Model P3700B. Intended to
be used as birthing beds for women of child bearing age in a labor,
delivery, recovery or postpartum setting in acute care. Recall #
Z-0548-2010r>
MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated November
16, 2009. Firm initiated recall is ongoing.
REASON: The brakes may not hold or lock.
PRODUCT: Delta/Delta XL Monitors with Omega S Package. Catalog numbers
MS18597 and MS18596. Recall # Z-0582-2010
MMANUFACTURER: Recalling Firm: Draeger Medical, Inc., Telford, PA, by
letter dated November 2009. Manufacturer: Draeger Medical Systems Inc.,
Danvers, MA. Firm initiated recall is ongoing.
REASON: Monitor is rebooting/resetting.
PRODUCT: 1) Symbia S Series SPECT System; Single-Photon Emission
Computed Tomography. Part: 8717741. Indications for use: SPECT + CT:
Perform scans and nuclear imaging studies with the same instrument. To
obtain attenuation corrected images and to provide registration of
anatomical and physiological images within the patient's anatomy. Recall
# Z-0583-2010;
2) Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography
and Computed Tomography). Indications for use: SPECT + CT: Perform scans
and nuclear imaging studies with the same instrument. To obtain
attenuation corrected images and to provide registration of anatomical
and physiological images within the patient's anatomy. a) Part: 8717733,
b) Part: 10275007, c) Part 10275008, d) Part: 10275009, e) Part
10275010. Recall # Z-0584-2010
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Hoffman Estates, IL, by letters dated November 18, 2009 and December 11,
2009. Manufacturer: Advanced Input Devices Inc., Coeur D Alene, ID. Firm
initiated recall is ongoing.
REASON: Some of the hand controllers of the Symbia S & T systems are
missing a resistor switch, and the absence of the switch may lead to
unintended system motion during camera set up activities.
PRODUCT:
1) Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB.
Ventilators within the specific range that are marked with one of the
following labels are already equipped with the new type of pressure
transducer. 1. Upgrade EM008/02/1; 2. Upgrade SV300 66 82 745 SV900 66
82 747. Recall # Z-0588-2010;
2) Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna,
Sweden Ventilators within the specified serial number range, that are
marked with on of the following labels on the inside of the lid of the
pneumatic unit are exempted since they have already been fitted with a
new type of the pressure transducer. 1. Upgrade EMO 12/02/1; 2. Upgrade
SV300 6682-745 SV900 66 82 747. Recall # Z-0589-2010
MANUFACTURER: Recalling Firm: MAQUET Inc., Wayne, NJ, by letters
commencing November 17, 2009 and ending November 23, 2009. Manufacturer:
Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is
ongoing.
REASON: Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E
should not be used with a system that may generate negative pressure
below -100 cm H2O (Closed system suctioning) due to the risk of damaging
the ventilator's pressure transducers./p>
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