Medical device recalls: February 2006
The FDA posted 112 medical device recall records in February 2006, from 52 recall events by 44 companies. 112 have not been classified yet.
Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.
Companies with the most recall events
- Roche Diagnostics Corp. · 3 events, 10 records
- Becton Dickinson & Company · 2 events, 5 records
- Cryolife Inc · 2 events, 4 records
- Boston Scientific Corp · 2 events, 3 records
- Medtronic Emergency Response Systems, Inc. · 2 events, 3 records
- Cygnus LLC · 2 events, 2 records
- Lumenis Inc. · 2 events, 2 records
- Regeneration Technologies, Inc. · 1 event, 21 records
FDA root cause
- Other · 109
- Nonconforming Material/Component · 3
Not yet classified (112)
The FDA has posted these records but has not published a class for them yet.
- Z-0563-06 · Cygnus LLC · posted Feb 28, 2006 · Terminated
The units were exhibiting tolerance stacking in the electronic circuit timer that controls the electric motor that spins the centrifuge and applies the centrifuge brake.
- Z-0564-06 · Cygnus LLC · posted Feb 28, 2006 · Terminated
When device was packaged, too much expanding foam was added causing the lid to deform and causing the lid locking mechanism to be out of alignment.
- Z-0566-06 · Roche Diagnostics Corp. · posted Feb 28, 2006 · Terminated
There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.
- Z-0567-06 · Roche Diagnostics Corp. · posted Feb 28, 2006 · Terminated
There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.
- Z-0568-06 · Roche Diagnostics Corp. · posted Feb 28, 2006 · Terminated
There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.
- Z-0569-06 · Roche Diagnostics Corp. · posted Feb 28, 2006 · Terminated
There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.
- Z-0570-06 · Roche Diagnostics Corp. · posted Feb 28, 2006 · Terminated
There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.
- Z-0571-06 · Roche Diagnostics Corp. · posted Feb 28, 2006 · Terminated
There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.
- Z-0572-06 · Roche Diagnostics Corp. · posted Feb 28, 2006 · Terminated
There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.
- Z-0573-06 · Roche Diagnostics Corp. · posted Feb 28, 2006 · Terminated
There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings..
- Z-0574-06 · Roche Diagnostics Corp. · posted Feb 28, 2006 · Terminated
May have tobramycin over-recovery at the trough level.
- Z-0576-06 · Nova Biomedical Corporation · posted Feb 28, 2006 · Terminated
Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs
- Z-0577-06 · Nova Biomedical Corporation · posted Feb 28, 2006 · Terminated
Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs
- Z-0578-06 · Nova Biomedical Corporation · posted Feb 28, 2006 · Terminated
Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs
- Z-0581-06 · Philips Medical Systems North America Co. Phillips · posted Feb 28, 2006 · Terminated
Potential lock-up of system requiring reboot of system.
- Z-0582-06 · Philips Medical Systems North America Co. Phillips · posted Feb 28, 2006 · Terminated
Potential lock-up of system requiring reboot of system.
- Z-0560-06 · Becton Dickinson & Company · posted Feb 25, 2006 · Terminated
BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.
- Z-0561-06 · Becton Dickinson & Company · posted Feb 25, 2006 · Terminated
BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.
- Z-0562-06 · Becton Dickinson & Company · posted Feb 25, 2006 · Terminated
BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.
- Z-0559-06 · Acclarent Inc · posted Feb 24, 2006 · Terminated
Device sterility may be compromised as evidenced by a loss of package integrity.
- Z-0532-06 · Toshiba American Med Sys Inc · posted Feb 23, 2006 · Terminated
In certain conditions the FOV of the lateral plane does not coincide with the X-ray exposed area, and consequently a part of the X-ray field may not be displayed in the magnification mode.
- Z-0540-06 · Medtronic Sofamor Danek Instrument Manufacturing · posted Feb 23, 2006 · Terminated
Depth indicators are incorrectly labeled (etched) on a measurement instrument.
- Z-0547-06 · Medtronic Emergency Response Systems, Inc. · posted Feb 23, 2006 · Terminated
One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.
- Z-0548-06 · Medtronic Emergency Response Systems, Inc. · posted Feb 23, 2006 · Terminated
One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.
- Z-0556-06 · Lumenis Inc. · posted Feb 23, 2006 · Terminated
During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip.
- Z-0557-06 · Diasorin Inc. · posted Feb 23, 2006 · Terminated
Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. The error occurs when running a combined plate on the ETI-Max 3000, with the ETI-Mumps IgG assay as the…
- Z-0558-06 · Tosoh Bioscience Inc · posted Feb 23, 2006 · Terminated
The inner foil packs of AIA-PACK ST TT3, Lot FX17440 contain an incorrect expiration date of 10/2005. The outer box is labeled with the correct expiration date of 10/2006.
- Z-0524-06 · Davol, Inc., Sub. C. R. Bard, Inc. · posted Feb 22, 2006 · Completed
Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula
- Z-0525-06 · Davol, Inc., Sub. C. R. Bard, Inc. · posted Feb 22, 2006 · Completed
Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula
- Z-0526-06 · Davol, Inc., Sub. C. R. Bard, Inc. · posted Feb 22, 2006 · Completed
Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula
- Z-0546-06 · Medtronic Emergency Response Systems, Inc. · posted Feb 22, 2006 · Terminated
Component leads may have intermittent connection to the printed circuit board assembly pads - which could render the device inoperative.
- Z-0760-06 · Davol, Inc., Sub. C. R. Bard, Inc. · posted Feb 22, 2006 · Completed
Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. (Extension of recall Z-0524/0526-06)
- Z-0761-06 · Davol, Inc., Sub. C. R. Bard, Inc. · posted Feb 22, 2006 · Completed
Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. (Extension of recall Z-0524/0526-06)
- Z-0762-06 · Davol, Inc., Sub. C. R. Bard, Inc. · posted Feb 22, 2006 · Completed
Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. (Extension of recall Z-0524/0526-06)
- Z-0534-06 · Medtronic Inc. Cardiac Rhythm Managment · posted Feb 18, 2006 · Terminated
An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion,…
- Z-0535-06 · Medtronic Inc. Cardiac Rhythm Managment · posted Feb 18, 2006 · Terminated
An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion,…
- Z-0536-06 · Medtronic Inc. Cardiac Rhythm Managment · posted Feb 18, 2006 · Terminated
An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion,…
- Z-0537-06 · Medtronic Inc. Cardiac Rhythm Managment · posted Feb 18, 2006 · Terminated
An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion,…
- Z-0538-06 · Medtronic Inc. Cardiac Rhythm Managment · posted Feb 18, 2006 · Terminated
An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion,…
- Z-0539-06 · Medtronic Inc. Cardiac Rhythm Managment · posted Feb 18, 2006 · Terminated
An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion,…
- Z-0517-06 · Spacelabs Medical Incorporated · posted Feb 16, 2006 · Terminated
The transducer used to compensate for pressure changes was mounted backwards on the printed circuit board assembly. The module will not compensate for pressure changes and CO2 readings will be inaccurate at higher altitudes.
- Z-0521-06 · Tung Keng Enterprise Co., Ltd. · posted Feb 16, 2006 · Terminated
The throttle spring, located in the hand throttle assembly, can fracture, resulting in the scooter not stopping when the user releases the throttle.
- Z-0522-06 · Tung Keng Enterprise Co., Ltd. · posted Feb 16, 2006 · Terminated
The throttle spring, located in the hand throttle assembly, can fracture, resulting in the scooter not stopping when the user releases the throttle.
- Z-0523-06 · Wright Medical Technology Inc · posted Feb 16, 2006 · Terminated
The product was not fully assembled prior to packaging.
- Z-0527-06 · Abbott Laboratories · posted Feb 16, 2006 · Terminated
T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%.
- Z-0528-06 · Diagnostic Products Corp. · posted Feb 16, 2006 · Terminated
The reagent for this kit lot (L2KTW 2,6 126) was manufactured with a raw material that can carryover and interfere with DPC Kit IMMULITE 2000 Estradiol (L2KE2) causing a false elevation in the observed estradiol concentration.
- Z-0529-06 · Lumenis Inc. · posted Feb 16, 2006 · Terminated
Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.
- Z-0530-06 · Depuy Orthopaedics, Inc. · posted Feb 16, 2006 · Terminated
The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.
- Z-0531-06 · Depuy Orthopaedics, Inc. · posted Feb 16, 2006 · Terminated
The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.
- Z-0219-05 · General Electric Med Systems LLC · posted Feb 14, 2006 · Terminated
Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.
- Z-0220-05 · General Electric Med Systems LLC · posted Feb 14, 2006 · Terminated
Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.
- Z-0513-06 · Abbott Laboratories MPG · posted Feb 14, 2006 · Terminated
There has been an increase in customer complaints observed for failure to calibrate or inability to generate patient result errors.
- Z-0514-06 · Hamilton Co · posted Feb 14, 2006 · Terminated
Heat sinking on power boards may not operate as intended and the board may cease to operate.
- Z-0515-06 · Draeger Medical, Inc. · posted Feb 14, 2006 · Terminated
Failure to generate an alarm when an unintended disconnection occurrs
- Z-0516-06 · Abbott Laboratories Diagnostic Div · posted Feb 14, 2006 · Terminated
The two Multiconstituent Calibrator (MCC) lot numbers 19906M200 and 20879M100 failed to meet product performance expectations throughout the labeled expiration period, as a result of the shortened expiration dating, two lots are now expired. The expiration…
- Z-0518-06 · Sunrise Medical Inc · posted Feb 14, 2006 · Terminated
While operating the powered wheelchair beyond a specified angle of recline, the wheelchair can travel at an unsafe speed when in this position.
- Z-0519-06 · Gish Biomedical Inc · posted Feb 14, 2006 · Terminated
Gish received four reports of potential leakage. All reports were associated with GBS coating. There was no patient injury reported.
- Z-0520-06 · Kinetic Concepts, Inc · posted Feb 14, 2006 · Terminated
To correct software issues in software versions 1.3 and 1.5 and to upgrade hatch latch handles to a more ergonomic design.
- Z-0455-06 · RC2 Brands Inc., The First Years · posted Feb 9, 2006 · Terminated
Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
- Z-0456-06 · RC2 Brands Inc., The First Years · posted Feb 9, 2006 · Terminated
Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
- Z-0457-06 · RC2 Brands Inc., The First Years · posted Feb 9, 2006 · Terminated
Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
- Z-0458-06 · RC2 Brands Inc., The First Years · posted Feb 9, 2006 · Terminated
Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
- Z-0459-06 · RC2 Brands Inc., The First Years · posted Feb 9, 2006 · Terminated
Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
- Z-0460-06 · RC2 Brands Inc., The First Years · posted Feb 9, 2006 · Terminated
Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida
- Z-0512-06 · Roche Diagnostics Corp. · posted Feb 9, 2006 · Terminated
A false negative result may be reported.
- Z-0503-06 · Teleflex Medical · posted Feb 8, 2006 · Terminated
Teleflex Medical determined that the distribution center shipped unreleased product which did not pass validated sterility test requirements.
- Z-0504-06 · Hospira Inc. · posted Feb 8, 2006 · Terminated
The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.
- Z-0505-06 · Hospira Inc. · posted Feb 8, 2006 · Terminated
The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.
- Z-0506-06 · Hospira Inc. · posted Feb 8, 2006 · Terminated
The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.
- Z-0507-06 · Baxter Healthcare Corp. · posted Feb 8, 2006 · Terminated
The BD catheter connector contained in the Epidural Anesthesia Trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.
- Z-0508-06 · Baxter Healthcare Corp. · posted Feb 8, 2006 · Terminated
The BD catheter connector contained in the Epidural Anesthesia Trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.
- Z-0509-06 · Baxter Healthcare Corp. · posted Feb 8, 2006 · Terminated
The BD catheter connector contained in the Epidural Anesthesia Trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.
- Z-0510-06 · Boston Scientific Corp · posted Feb 8, 2006 · Terminated
The basket wire assembly may detach from the drive wire while in the patient.
- Z-0511-06 · Boston Scientific Corp · posted Feb 8, 2006 · Terminated
The basket wire assembly may detach from the drive wire while in the patient.
- Z-0481-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0482-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0483-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0484-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0485-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0486-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0487-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0488-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0489-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0490-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0491-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0492-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0493-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0494-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0495-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0496-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0497-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0498-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0499-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0500-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0501-06 · Regeneration Technologies, Inc. · posted Feb 7, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0502-06 · Abbott Spine · posted Feb 7, 2006 · Terminated
Implants were manufactured without radiographic markers.
- Z-0466-06 · Omron Healthcare, Inc. · posted Feb 4, 2006 · Terminated
Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip.
- Z-0467-06 · Becton Dickinson & Company · posted Feb 4, 2006 · Terminated
The catheter connector could not be sufficiently tightened to secure the catheter tubing.
- Z-0468-06 · Becton Dickinson & Company · posted Feb 4, 2006 · Terminated
The catheter connector could not be sufficiently tightened to secure the catheter tubing.
- Z-0469-06 · Possis Medical, Inc · posted Feb 4, 2006 · Terminated
It was reported that the catheter model inside the product tray and box was not an XMI RX Plus, but an XMI over-the-wire model.
- Z-0470-06 · Chembio Diagnostic System Inc · posted Feb 4, 2006 · Terminated
Firm received one report of a false negative with the positive control. Internal testing by the firm has shown that the kit lot may result in invalid or false negative interpretations.
- Z-0471-06 · AGFA Corp. · posted Feb 4, 2006 · Terminated
Mislabeling; Product labeled Cronex 10T actually contains Afga, Curix Ultra UVL Plus.
- Z-0472-06 · Teco Diagnostics · posted Feb 4, 2006 · Terminated
When reading the Nitrite parameter on the Teco Diagnostics URS-10 strips, some positive nitrite samples may be read by the machine as negative.
- Z-0473-06 · Boston Scientific Corp · posted Feb 4, 2006 · Terminated
Product is mislabeled with the incorrect catheter curve description.
- Z-0474-06 · Beckman Coulter Inc · posted Feb 4, 2006 · Terminated
There is a risk of sample misidentification when processing samples in the Manual aspiration mode.
- Z-0475-06 · Beckman Coulter Inc · posted Feb 4, 2006 · Terminated
There is a risk of sample misidentification when processing samples in the Manual aspiration mode.
- Z-0476-06 · QLT USA, Inc. · posted Feb 4, 2006 · Terminated
Injectable needles were included in procedure kits instead of sterile blunt cannulas.
- Z-0477-06 · Cryolife Inc · posted Feb 4, 2006 · Terminated
During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.
- Z-0478-06 · Cryolife Inc · posted Feb 4, 2006 · Terminated
During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.
- Z-0479-06 · Cryolife Inc · posted Feb 4, 2006 · Terminated
During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.
- Z-0480-06 · Cryolife Inc · posted Feb 4, 2006 · Terminated
Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection.
- Z-0410-06 · Boston Scientific Corporation · posted Feb 1, 2006 · Terminated
The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.
Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.