Medical device recalls: October 2003
The FDA posted 91 medical device recall records in October 2003, from 62 recall events by 46 companies. 91 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
- Wilson-Cook Medical Inc · 5 events, 5 records
- GE Medical Systems Information Technologies · 3 events, 5 records
- Beckman Coulter Inc · 3 events, 4 records
- Cryolife Inc · 3 events, 4 records
- Roche Diagnostics Corp. · 3 events, 3 records
- Biotronik Inc · 2 events, 6 records
- bioMerieux · 2 events, 3 records
- Hill-Rom Manufacturing, Inc. · 2 events, 3 records
FDA root cause
- Other · 87
- Process control · 3
- Component design/selection · 1
Not yet classified (91)
The FDA has posted these records but has not published a class for them yet.
- Z-0072-04 · Biotronik Inc · posted Oct 31, 2003 · Terminated
Potential extended charge time anomalies.
- Z-0073-04 · Biotronik Inc · posted Oct 31, 2003 · Terminated
Potential extended charge time anomalies.
- Z-0074-04 · Biotronik Inc · posted Oct 31, 2003 · Terminated
Potential extended charge time anomalies.
- Z-0075-04 · Biotronik Inc · posted Oct 31, 2003 · Terminated
Potential extended charge time anomalies.
- Z-0076-04 · Biotronik Inc · posted Oct 31, 2003 · Terminated
Potential for early depletion of Implantable Cardioverter Defibrillator battery.
- Z-0077-04 · Biotronik Inc · posted Oct 31, 2003 · Terminated
Potential for early depletion of Implantable Cardioverter Defibrillator battery.
- Z-0078-04 · Electro Medical Systems (EMS SA) · posted Oct 31, 2003 · Terminated
Failure of foot pedal to activate device
- Z-0079-04 · Wilson-Cook Medical Inc · posted Oct 31, 2003 · Terminated
There is a possibility that the affected devices would not capture a biopsy during a procedure.
- Z-0080-04 · Wilson-Cook Medical Inc · posted Oct 31, 2003 · Terminated
The label is missing the Rx Only symbol.
- Z-0070-04 · Misonix, Inc · posted Oct 30, 2003 · Terminated
Firm received complaints of tingling or static shock sensation to end users caused by forcing the output connector into its receptacle misaligned. The misalignment causes additional voltage to appear on the patient probe.
- Z-0071-04 · Boston Scientific · posted Oct 30, 2003 · Terminated
The product has the potential to break during withdrawal process.
- Z-0001-04 · Sedecal USA, Inc · posted Oct 29, 2003 · Terminated
A minimum source-skin-distance of less than 30 cm and not identifying the tube manufacturer on the tube housing label resulted in the SP-HF-4.0 Portable Systems not complying with the U.S. Federal performance standard.
- Z-0051-04 · Propper Mfg Co Inc · posted Oct 24, 2003 · Terminated
Deviation in capillary tubes could cause a 10% increase in read out values which could make a slight anemic patient appear to have a normal reading.
- Z-0052-04 · St Jude Medical · posted Oct 24, 2003 · Terminated
Under certain circumstances, pacemaker has a potential to deliver a short coupled pacing interval of approx. 300 msec (200ppm). It is also possible that a patient may experience (up to max of 12) shorter than anticipated pacing intervals.
- e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures ↗Z-0053-04 · Siemens Medical Solutions USA, Inc. · posted Oct 24, 2003 · Terminated
The detector's radial brake may not be applied properly, allowing unintended motion which could result in injury to the patient or operator.
- Z-0054-04 · Western a Scott Fetzer Co · posted Oct 24, 2003 · Terminated
The demand valve is defective and does not function as intended in the 'Conservative Mode'.
- Z-0055-04 · Western a Scott Fetzer Co · posted Oct 24, 2003 · Terminated
The demand valve is defective and does not function as intended in the 'Conservative Mode'.
- Z-0056-04 · Western a Scott Fetzer Co · posted Oct 24, 2003 · Terminated
The demand valve is defective and does not function as intended in the 'Conservative Mode'.
- Z-0057-04 · Hill-Rom Manufacturing, Inc. · posted Oct 24, 2003 · Terminated
Power cord overheating
- Z-0058-04 · Hill-Rom Manufacturing, Inc. · posted Oct 24, 2003 · Terminated
Reports of patient entrapment between mattress and side-rails.
- Z-0059-04 · Hill-Rom Manufacturing, Inc. · posted Oct 24, 2003 · Terminated
Reports of patient entrapment between mattress and side-rails.
- Z-0060-04 · Nova Biomedical Corporation · posted Oct 24, 2003 · Terminated
Degradation of the magnesium sensor could result in low ionozed magnesium patient samples
- Z-0061-04 · Nova Biomedical Corporation · posted Oct 24, 2003 · Terminated
Degradation of the magnesium sensor could result in low ionozed magnesium patient samples
- Z-0062-04 · Meridian Bioscience Inc · posted Oct 24, 2003 · Terminated
The kits were packaged with incorrect dispensing pipettes.
- Z-0063-04 · Abbott Laboratories HPD/ADD/GPRD · posted Oct 24, 2003 · Terminated
Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100.
- Z-0064-04 · Acist Medical Systems · posted Oct 24, 2003 · Terminated
Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak.
- Z-0065-04 · Cryolife Inc · posted Oct 24, 2003 · Terminated
Additional information obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patient had pneumonia and it possibly might have been a systemic infection.
- Z-0066-04 · Bayer Corp. · posted Oct 24, 2003 · Terminated
Potential for bias shift in pO2 values due to air bubble in sample path
- Z-0067-04 · Beckman Coulter Inc · posted Oct 24, 2003 · Terminated
Motor driver boards may contain wrong type of microchip which does not have obstruction detection feature.
- Z-0068-04 · Wilson-Cook Medical Inc · posted Oct 24, 2003 · Terminated
The product was labeled with a 5 year expiration date instead of a 1 year expiration date.
- Z-0069-04 · Remel, Inc · posted Oct 24, 2003 · Terminated
Some of the product lots exhibit no growth of quality control strains of Neisseria gonorrhoeae
- Z-0048-04 · Wilson-Cook Medical Inc · posted Oct 22, 2003 · Terminated
Product may be packaged with an incorrect instructions for use (IFU) booklet.
- Z-0002-04 · Bard Peripheral Vascular Inc · posted Oct 15, 2003 · Terminated
Product intended for distribution outside USA was distributed without premarket notification requirements being met.
- Z-0003-04 · Liberty Medical Supplies · posted Oct 15, 2003 · Terminated
The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box .
- Z-0004-04 · Liberty Medical Supplies · posted Oct 15, 2003 · Terminated
The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box .
- Z-0005-04 · Liberty Medical Supplies · posted Oct 15, 2003 · Terminated
The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box .
- Z-0006-04 · Inamed Corp · posted Oct 15, 2003 · Terminated
The 400cc, 460cc, 500cc and 560cc sizes of the McGhan Style 40 Silicone-filled Breast Implants were manufactured using one size smaller shells than required.
- Z-0008-04 · Rultract Inc · posted Oct 15, 2003 · Terminated
Component spring or nut may loosen, detach, and fall into chest of patient during surgical procedure.
- Z-0009-04 · Siemens Medical Solutions USA, Inc · posted Oct 15, 2003 · Terminated
possible movement of table tilt and table longitudinal
- Z-0010-04 · Bard Peripheral Vascular · posted Oct 15, 2003 · Terminated
Mislabeled. 7mm balloon labeled 12mm
- Z-0011-04 · GE Medical Systems Information Technologies · posted Oct 15, 2003 · Terminated
Reports of broken plug ground pins on AC power cords for patient monitors.
- Z-0012-04 · Roche Diagnostics Corp. · posted Oct 15, 2003 · Terminated
Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted.
- Z-0013-04 · GE Medical Systems Information Technologies · posted Oct 15, 2003 · Terminated
Instructions for use contained incorrect sensor reference.
- Z-0014-04 · GE Medical Systems Information Technologies · posted Oct 15, 2003 · Terminated
Instructions for use contained incorrect sensor reference.
- Z-0015-04 · GE Medical Systems Information Technologies · posted Oct 15, 2003 · Terminated
Instructions for use contained incorrect sensor reference.
- Z-0016-04 · Smith And Nephew, Inc. Wound Management Division · posted Oct 15, 2003 · Terminated
Product may not meet the established stability specification before the end of labeled expiry date.
- Z-0017-04 · Plus Endoprothetik AG · posted Oct 15, 2003 · Terminated
Labeling/packaging mix-up.
- Z-0018-04 · Cordis Neurovascular, Inc. · posted Oct 15, 2003 · Terminated
These catheters have J-shape tips instead of the labeled MP (multipurpose) tips and also are packed into the incorrect tip tray.
- Z-0019-04 · Cryolife Inc · posted Oct 15, 2003 · Terminated
The heart valve procurement exceeded the warm ischemic time criteria.
- Z-0020-04 · Vital Concepts, Inc. · posted Oct 15, 2003 · Terminated
The suction valve may become stuck in the 'suction on' position under vacuum.
- Z-0021-04 · Vital Concepts, Inc. · posted Oct 15, 2003 · Terminated
The suction valve may become stuck in the 'suction on' position under vacuum.
- Z-0022-04 · Vital Concepts, Inc. · posted Oct 15, 2003 · Terminated
The suction valve may become stuck in the 'suction on' position under vacuum.
- Z-0023-04 · Vital Concepts, Inc. · posted Oct 15, 2003 · Terminated
The suction valve may become stuck in the 'suction on' position under vacuum.
- Z-0024-04 · Vital Concepts, Inc. · posted Oct 15, 2003 · Terminated
The suction valve may become stuck in the 'suction on' position under vacuum.
- Z-0025-04 · Vital Concepts, Inc. · posted Oct 15, 2003 · Terminated
The suction valve may become stuck in the 'suction on' position under vacuum.
- Z-0026-04 · Surgical Specialties Corp · posted Oct 15, 2003 · Terminated
text on product handle is incorrect
- Z-0027-04 · Instrumentation Laboratory Co. · posted Oct 15, 2003 · Terminated
Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L.
- Z-0028-04 · Roche Diagnostics Corp. · posted Oct 15, 2003 · Terminated
Patient samples with very high lactate values may falsely be reported as within the normal range without the instrument giving a warning flag to the technician.
- Z-0029-04 · Dow Corning Corp. · posted Oct 15, 2003 · Terminated
May be contaminated with iron, chromium and nickel from stainless steel equipment failure during manufacture.
- Z-0030-04 · Boston Scientific Scimed · posted Oct 15, 2003 · Terminated
Some of the recalled catheters have a component that has levels of pyrogens above specification.
- Z-0031-04 · Boston Scientific Scimed · posted Oct 15, 2003 · Terminated
Some of the recalled catheters have a component that has levels of pyrogens above specification.
- Z-0032-04 · Boston Scientific Scimed · posted Oct 15, 2003 · Terminated
Some of the recalled catheters have a component that has levels of pyrogens above specification.
- Z-0033-04 · VIASYS Med Systems · posted Oct 15, 2003 · Terminated
The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
- Z-0034-04 · VIASYS Med Systems · posted Oct 15, 2003 · Terminated
The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
- Z-0035-04 · VIASYS Med Systems · posted Oct 15, 2003 · Terminated
The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
- Z-0036-04 · VIASYS Med Systems · posted Oct 15, 2003 · Terminated
The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
- Z-0037-04 · VIASYS Med Systems · posted Oct 15, 2003 · Terminated
The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
- Z-0038-04 · VIASYS Med Systems · posted Oct 15, 2003 · Terminated
The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
- Z-0039-04 · Beckman Coulter Inc · posted Oct 15, 2003 · Terminated
Samples with high fat content will not count platelets accurately.
- Z-0040-04 · Beckman Coulter Inc · posted Oct 15, 2003 · Terminated
Samples with high fat content will not count platelets accurately.
- Z-0041-04 · Siemens Medical Solutions USA, Inc. · posted Oct 15, 2003 · Terminated
Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions.
- Z-0042-04 · Ortho Development Corporation · posted Oct 15, 2003 · Terminated
The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out.
- Z-0043-04 · Microaire Surgical Instruments · posted Oct 15, 2003 · Terminated
Wiring pin locking mechanism defective, potential to come apart in surgical site.
- Z-0044-04 · Microaire Surgical Instruments · posted Oct 15, 2003 · Terminated
Wiring pin locking mechanism defective, potential to come apart in surgical site.
- Z-0045-04 · Vasca, Inc. · posted Oct 15, 2003 · Terminated
Outer kit mislabeled with an extended expiration date
- Z-0046-04 · Beckman Coulter Inc · posted Oct 15, 2003 · Terminated
Package insert contains inaccurate information.
- Z-0047-04 · Olympus America Inc. · posted Oct 15, 2003 · Terminated
Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file.
- Z-1209-03 · bioMerieux · posted Oct 15, 2003 · Terminated
Product's decrease in sensitivity may result in false negative results
- Z-1237-03 · GE Medical Systems Information Technologies · posted Oct 15, 2003 · Terminated
Wrong connector attached to blood pressure cuff.
- Z-1238-03 · bioMerieux · posted Oct 15, 2003 · Terminated
Complaints of prolonged clot times.
- Z-1239-03 · bioMerieux · posted Oct 15, 2003 · Terminated
Complaints of prolonged clot times.
- Z-1240-03 · Misys Healthcare Systems · posted Oct 15, 2003 · Terminated
Software Defect. Data used in the diagnosis and or treatment of a patient's illness are missing from the patient result report.
- Z-1243-03 · The Anspach Effort, Inc. · posted Oct 15, 2003 · Terminated
Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.
- Z-1279-03 · Bausch & Lomb Incorporated · posted Oct 15, 2003 · Terminated
The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.
- Z-1280-03 · Bausch & Lomb Incorporated · posted Oct 15, 2003 · Terminated
The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.
- Z-1292-03 · Wilson-Cook Medical Inc · posted Oct 15, 2003 · Terminated
The product was labeled 'esophageal', but contained a 'biliary' ballon
- Z-1293-03 · Roche Diagnostics Corp. · posted Oct 15, 2003 · Terminated
Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch.
- Z-1294-03 · Becton Dickinson & Co. · posted Oct 15, 2003 · Terminated
Broth for growing selective bacteria may fail to inhibit overgrowth of gram negative microorganisms resulting in the inability to isolate Group B Streptococci.
- Z-1295-03 · Stryker Howmedica Osteonics · posted Oct 15, 2003 · Terminated
The device does not have an oblong hole for dynamic locking as required.
- Z-1296-03 · Cryolife Inc · posted Oct 15, 2003 · Terminated
Firm received additional information from the procurement agency indicating that the donor's serological test sample may have been sufficiently diluted by transfusion/infusion to invalidate the HIV and Hepatitis B and C screening test results.
- Z-1297-03 · Cryolife Inc · posted Oct 15, 2003 · Terminated
Firm received additional information from the procurement agency indicating that the donor's serological test sample may have been sufficiently diluted by transfusion/infusion to invalidate the HIV and Hepatitis B and C screening test results.
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.