Medical device recalls: March 2003
The FDA posted 79 medical device recall records in March 2003, from 60 recall events by 45 companies. 79 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
- Misys Healthcare Systems · 6 events, 6 records
- Cryolife Inc · 4 events, 4 records
- Beckman Coulter Inc · 3 events, 4 records
- Abbott Health Products, Inc. · 2 events, 4 records
- Baxter Healthcare Corp. · 2 events, 3 records
- Abbott Laboratories · 2 events, 2 records
- Biomerieux, Inc. · 2 events, 2 records
- Siemens Medical Solutions USA, Inc. · 2 events, 2 records
FDA root cause
- Other · 78
- Software design · 1
Not yet classified (79)
The FDA has posted these records but has not published a class for them yet.
- Z-0689-03 · Abbott Health Products, Inc. · posted Mar 29, 2003 · Terminated
Unexpected false positive TCA results
- Z-0690-03 · Abbott Health Products, Inc. · posted Mar 29, 2003 · Terminated
Unexpected false positive TCA results
- Z-0691-03 · Abbott Health Products, Inc. · posted Mar 29, 2003 · Terminated
Unexpected false positive TCA results
- Z-0692-03 · Beckman Coulter Inc · posted Mar 29, 2003 · Terminated
False results from secondary pour off tubes
- Z-0693-03 · Beckman Coulter Inc · posted Mar 29, 2003 · Terminated
False results from secondary pour off tubes
- Z-0694-03 · Advanced Sterilization Products · posted Mar 29, 2003 · Terminated
Test strips which are used for QC of sterilant solution fail prematurely due to ingress of moisture.
- Z-0695-03 · Advanced Sterilization Products · posted Mar 29, 2003 · Terminated
Test strips which are used for QC of sterilant solution fail due to ingress of moisture.
- Z-0687-03 · I-Flow Corporation · posted Mar 27, 2003 · Terminated
Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up.
- Z-0688-03 · Thoratec Corp · posted Mar 27, 2003 · Terminated
Driveline tubing connections on the SVL if under STRESS condition may snap off, VAD support is compromised, a serious injury or death can occur.
- Z-0677-03 · DCI Donor Services Tissue Services Division · posted Mar 26, 2003 · Terminated
Human tissue was procured from donor using non-sterile instruments.
- Z-0678-03 · Misys Healthcare Systems · posted Mar 26, 2003 · Terminated
Software anomally. Graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol.
- Z-0679-03 · Abbott Laboratories HPD/ADD · posted Mar 26, 2003 · Terminated
The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.
- Z-0680-03 · Abbott Laboratories HPD/ADD · posted Mar 26, 2003 · Terminated
The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.
- Z-0681-03 · Abbott Laboratories HPD/ADD · posted Mar 26, 2003 · Terminated
The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.
- Z-0682-03 · Invacare Corp · posted Mar 26, 2003 · Terminated
A short circuit within the charger harness may cause heat damage to the units with potential for fire.
- Z-0683-03 · EMD Chemicals Inc · posted Mar 26, 2003 · Terminated
The Ethanol Standard is OOS on the high end. The results were 1.58 mg/mL while the specification is 1.477-1.538 mg/mL.
- Z-0684-03 · EMD Chemicals Inc · posted Mar 26, 2003 · Terminated
The Ethanol Standard is OOS on the low end. The results were 0.44 mg/mL while the specification is 0.48-0.52 mg/mL.
- Z-0685-03 · EMD Chemicals Inc · posted Mar 26, 2003 · Terminated
Difficulty in reading slides due to the stain is much greener than normal.
- Z-0667-03 · Roche Diagnostics Corp. · posted Mar 21, 2003 · Terminated
After a cassette change, patient results and controls may be up to 40% too low or too high due to calibration factor variation.
- Z-0668-03 · Toshiba American Med Sys Inc · posted Mar 21, 2003 · Terminated
Misassembly can cause fire.
- Z-0669-03 · Beckman Coulter Inc · posted Mar 21, 2003 · Terminated
Incorrect Hemoglobin result can be reported with software version 2A and higher.
- Z-0670-03 · Misys Healthcare Systems · posted Mar 21, 2003 · Terminated
Software anomaly. The HIDE command used to suppress suspected individual microbiology observations does not work in GUI inquiry
- Z-0671-03 · Permobile Inc. · posted Mar 21, 2003 · Terminated
Incidents were reported where a drive wheel has come off its motor axle, due either to loosening of the wheel bolt or a broken wheel bolt.
- Z-0672-03 · Cryolife Inc · posted Mar 21, 2003 · Terminated
Microorganisms were detected in distributed allografts.
- Z-0673-03 · Cryolife Inc · posted Mar 21, 2003 · Terminated
Microorganisms were detected in distributed donor tissue.
- Z-0674-03 · Cti Pet Systems Inc · posted Mar 21, 2003 · Terminated
Incorrect patient information is displayed in the reconstructed images of a whole body patient scan.
- Z-0675-03 · Cryolife Inc · posted Mar 21, 2003 · Terminated
An allograft associated with this donor has been linked to an alleged infection.
- Z-0676-03 · Cryolife Inc · posted Mar 21, 2003 · Terminated
An allograft associated with this donor has been linked to an alleged infection.
- Z-0653-03 · Simmler Inc · posted Mar 20, 2003 · Terminated
Fixing solution bottles are labeled as buffering solution.
- Z-0659-03 · Interpore Cross International Inc · posted Mar 20, 2003 · Terminated
Instrument fell apart during cleaning prior to surgery.
- Z-0660-03 · Baxter Healthcare Corp. · posted Mar 20, 2003 · Terminated
Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP)
- Z-0661-03 · Baxter Healthcare Corp. · posted Mar 20, 2003 · Terminated
Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP)
- Z-0662-03 · Medtronic Xomed, Inc. · posted Mar 20, 2003 · Terminated
Product packaging pouches may be open thereby compomising the sterile barrier.
- Z-0663-03 · Curon Medical Inc · posted Mar 20, 2003 · Terminated
Catheter shaft has potential to crack during use.
- Z-0664-03 · Terumo Cardiovascular Systems Corp · posted Mar 20, 2003 · Terminated
There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery.
- Z-0665-03 · Implant Innovations, Inc. · posted Mar 20, 2003 · Terminated
Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size.
- Z-0666-03 · Symbiosis Corp. · posted Mar 20, 2003 · Terminated
The 180 cm guidewire is mislabeled as 260 cm and the 260 cm guidewire is mislabeled as 180 cm.
- Z-0654-03 · Digene Corp · posted Mar 19, 2003 · Terminated
In Vitro diagnostic test kit may produce false positive patient results
- Z-0655-03 · Digene Corp · posted Mar 19, 2003 · Terminated
In Vitro diagnostic test kit may produce false positive patient results
- Z-0656-03 · Digene Corp · posted Mar 19, 2003 · Terminated
In Vitro diagnostic test kit may produce false positive patient results
- Z-0657-03 · Digene Corp · posted Mar 19, 2003 · Terminated
In Vitro diagnostic test kit may produce false positive patient results
- Z-0658-03 · De Royal Industries · posted Mar 19, 2003 · Terminated
Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use.
- Z-0646-03 · Misys Healthcare Systems · posted Mar 13, 2003 · Terminated
Two customers report that the organism identified on the patient's lab file do not match the reported susceptibility battery.
- Z-0647-03 · Sunquest Information Systems · posted Mar 13, 2003 · Terminated
Software anomaly, incorrect coding. Some comments were not transfered when coming from the Reference Laboratory Interface.
- Z-0648-03 · Abbott Laboratories · posted Mar 13, 2003 · Terminated
Product elicits fluorescent signal interference due to contamination.
- Z-0630-03 · Lifescan Inc · posted Mar 12, 2003 · Terminated
The Test Strips have manufacturing errors, in that the 'Confirmation Dot' is off-center or split in half, and defective bottle Cap.
- Z-0631-03 · Misys Healthcare Systems · posted Mar 12, 2003 · Terminated
Missing patient data on Location Chart Copy Cumulative Reports.
- Z-0632-03 · Abbott Laboratories · posted Mar 12, 2003 · Terminated
Product may elicit fluorescent signal interference due to bacterial contamination.
- Z-0633-03 · Varian Medical Systems Inc · posted Mar 12, 2003 · Terminated
The product has a software problem. This could result in a treatment without a motorized wedge where one had been planned.
- Z-0634-03 · BD Opthalmic Systems · posted Mar 12, 2003 · Terminated
Microkeratome Blade may cause irregular corneal flap which may delay patients procedure.
- Z-0635-03 · American Healthcare Products Inc · posted Mar 12, 2003 · Terminated
Unfit for intended use due to stickiness.
- Z-0644-03 · Medline Industries Inc · posted Mar 12, 2003 · Terminated
Some of the kits labeled as latex free contain latex gloves which are properly labeled.
- Z-0645-03 · Medline Industries Inc · posted Mar 12, 2003 · Terminated
Some of the kits labeled as latex free contain latex gloves which are properly labeled.
- Z-0612-03 · Alcon Laboratories, Inc · posted Mar 6, 2003 · Terminated
Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.
- Z-0613-03 · Remel, Inc. · posted Mar 6, 2003 · Terminated
Packages of Cefuroxime susceptibility disks erroneously contained Cefaclor susceptibility disks.
- Z-0614-03 · Misys Healthcare Systems · posted Mar 6, 2003 · Terminated
Software anomaly. Rejecting the selected Autofiling status may result in the change being accepted rather than rejected.
- Z-0615-03 · Thermo Biostar, Incorporated · posted Mar 6, 2003 · Terminated
Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.
- Z-0616-03 · Thermo Biostar, Incorporated · posted Mar 6, 2003 · Terminated
Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.
- Z-0617-03 · Siemens Medical Solutions USA, Inc. · posted Mar 6, 2003 · Terminated
Unintended yoke rotational motion.
- Z-0618-03 · Medtronic,Inc/Rice Creek Facil · posted Mar 6, 2003 · Terminated
An RF pulse occurs each time the temperature set point increase button is activated while ablating and this can result in heart rhythm disturbances.
- Z-0619-03 · Beckman Coulter Inc · posted Mar 6, 2003 · Terminated
Spring failure, design defect in component.
- Z-0620-03 · Merit Medical Systems, Inc · posted Mar 6, 2003 · Terminated
A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
- Z-0621-03 · Merit Medical Systems, Inc · posted Mar 6, 2003 · Terminated
A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
- Z-0622-03 · Merit Medical Systems, Inc · posted Mar 6, 2003 · Terminated
A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
- e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures ↗Z-0623-03 · Siemens Medical Solutions USA, Inc. · posted Mar 6, 2003 · Terminated
Unexpected release of the radial and rotate brakes in the case of multiple simultaneous fault conditions.
- Z-0624-03 · E Med Future Inc · posted Mar 6, 2003 · Terminated
Their NeedleZap devices were not manufactured in accordance with the Quality System Regulations, and were shipped without an approved PMA.
- Z-0625-03 · Medtronic, Inc. · posted Mar 6, 2003 · Terminated
PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon
- Z-0626-03 · Misys Healthcare Systems · posted Mar 6, 2003 · Terminated
Software anomaly. Patient results may be filed in the incorrect patient file
- Z-0627-03 · Abbott Health Products, Inc. · posted Mar 6, 2003 · Terminated
Results lower than package insert ranges
- Z-0628-03 · Biomerieux, Inc. · posted Mar 6, 2003 · Terminated
Vial to vial variability which can result in prolonged clot times.
- Z-0629-03 · Biomerieux, Inc. · posted Mar 6, 2003 · Terminated
Product is being recalled due to vial to vial variability of clotting time results.
- Z-0424-03 · X-Cel X-Ray Corp · posted Mar 5, 2003 · Terminated
The X-Ray system contained a defective X-Ray tube shield.
- Z-0605-03 · Baxter Healthcare Corp. · posted Mar 5, 2003 · Terminated
Meridian hemodialysis instrument may reset when in shutdown mode causing the system to reset with potential for patient increased bioburden exposure.
- Z-0606-03 · Integra LifeSciences Corp · posted Mar 5, 2003 · Terminated
The check valve in the patient line may stick in the closed position.
- Z-0607-03 · Novartis Nutrition Corp · posted Mar 5, 2003 · Terminated
Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern.
- Z-0608-03 · Novartis Nutrition Corp · posted Mar 5, 2003 · Terminated
Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern.
- Z-0609-03 · Novartis Nutrition Corp · posted Mar 5, 2003 · Terminated
Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern.
- Z-0610-03 · Datex-Ohmeda · posted Mar 5, 2003 · Terminated
Falsely high blood oxygen saturation readings in some circumstances could result in no alarm in a critical life-threatening situation.
- Z-0611-03 · Datex-Ohmeda · posted Mar 5, 2003 · Terminated
Falsely high blood oxygen saturation readings in some circumstances which could result in no alarm in a critical life-threatening situation.
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.