Medical device recalls: January 2003
The FDA posted 73 medical device recall records in January 2003, from 32 recall events by 26 companies. 73 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
- Sunquest Information Systems · 3 events, 3 records
- Baxter Healthcare Corp. · 2 events, 9 records
- Zimmer Inc. · 2 events, 9 records
- Beckman Coulter Inc · 2 events, 5 records
- Misys Healthcare Systems · 2 events, 2 records
- Ultracell Medical Technologies · 1 event, 13 records
- Haemonetics Corporation · 1 event, 6 records
- Sterile Surgical Systems Llc · 1 event, 5 records
FDA root cause
- Other · 72
- Process control · 1
Not yet classified (73)
The FDA has posted these records but has not published a class for them yet.
- Z-0462-03 · Novoste Corporation · posted Jan 30, 2003 · Terminated
Mislabeling. Source calibrated incorrectly, resultant dose rate lower than expected.
- Z-0468-03 · Megadyne Medical Products, Inc · posted Jan 30, 2003 · Terminated
The metal substrate cautery tip may break during use.
- Z-0469-03 · Megadyne Medical Products, Inc · posted Jan 30, 2003 · Terminated
The metal substrate cautery tip may break during use.
- Z-0470-03 · Encision, Inc. · posted Jan 30, 2003 · Terminated
Reports of needle fixed-tip electrodes becoming loose or breaking off.
- Z-0478-03 · Ultracell Medical Technologies · posted Jan 30, 2003 · Terminated
Sterility of the device is compromised
- Z-0479-03 · Ultracell Medical Technologies · posted Jan 30, 2003 · Terminated
Sterility of the device is compromised
- Z-0480-03 · Ultracell Medical Technologies · posted Jan 30, 2003 · Terminated
Sterility of the device is compromised
- Z-0481-03 · Ultracell Medical Technologies · posted Jan 30, 2003 · Terminated
Sterility of the device is compromised
- Z-0482-03 · Ultracell Medical Technologies · posted Jan 30, 2003 · Terminated
Sterility of the device is compromised
- Z-0483-03 · Ultracell Medical Technologies · posted Jan 30, 2003 · Terminated
Sterility of the device is compromised
- Z-0484-03 · Ultracell Medical Technologies · posted Jan 30, 2003 · Terminated
Sterility of the device is compromised
- Z-0485-03 · Ultracell Medical Technologies · posted Jan 30, 2003 · Terminated
Sterility of the device is compromised
- Z-0486-03 · Ultracell Medical Technologies · posted Jan 30, 2003 · Terminated
Sterility of the device is compromised
- Z-0487-03 · Ultracell Medical Technologies · posted Jan 30, 2003 · Terminated
Sterility of the device is compromised
- Z-0488-03 · Ultracell Medical Technologies · posted Jan 30, 2003 · Terminated
Sterility of the device is compromised
- Z-0489-03 · Ultracell Medical Technologies · posted Jan 30, 2003 · Terminated
Sterility of the device is compromised
- Z-0490-03 · Ultracell Medical Technologies · posted Jan 30, 2003 · Terminated
Sterility of the device is compromised
- Z-0491-03 · Thoratec Corp · posted Jan 30, 2003 · Terminated
The product is mislabeled, in that the LVAD Pneumatic Lead 5' is identified with a BLUE Collar (instead of Red) in order to distinguish RVAD.
- Z-0492-03 · Misys Healthcare Systems · posted Jan 30, 2003 · Terminated
Software anomally. English text code does not translate.
- Z-0493-03 · Siemens Medical Systems Inc · posted Jan 30, 2003 · Terminated
There is unintended system movement or unwanted automatic movement of the tabletop.
- Z-0494-03 · Beckman Coulter Inc · posted Jan 30, 2003 · Terminated
Primary tube sampling issue may cause false low results.
- Z-0495-03 · Misys Healthcare Systems · posted Jan 30, 2003 · Terminated
An incorrect collection date and time may be accepted and filed to the patient file.
- Z-0496-03 · Sorenson Medical, Inc. · posted Jan 30, 2003 · Terminated
Catheters have 2 unvalidated seal product configurations to produce a new hybrid seal that had not been verified or validated.
- Z-0497-03 · Sunquest Information Systems · posted Jan 30, 2003 · Terminated
Software system defect resulting in incomplete patient results information.
- Z-0498-03 · Haemonetics Corporation · posted Jan 30, 2003 · Terminated
Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
- Z-0499-03 · Haemonetics Corporation · posted Jan 30, 2003 · Terminated
Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
- Z-0500-03 · Haemonetics Corporation · posted Jan 30, 2003 · Terminated
Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
- Z-0501-03 · Haemonetics Corporation · posted Jan 30, 2003 · Terminated
Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
- Z-0502-03 · Haemonetics Corporation · posted Jan 30, 2003 · Terminated
Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
- Z-0503-03 · Haemonetics Corporation · posted Jan 30, 2003 · Terminated
Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
- Z-0467-03 · Stryker Howmedica Osteonics · posted Jan 28, 2003 · Terminated
Product mix-up. 16mm stem in a 18mm package.
- Z-0472-03 · Zimmer Inc. · posted Jan 28, 2003 · Terminated
The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
- Z-0473-03 · Zimmer Inc. · posted Jan 28, 2003 · Terminated
The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
- Z-0474-03 · Zimmer Inc. · posted Jan 28, 2003 · Terminated
The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
- Z-0475-03 · Zimmer Inc. · posted Jan 28, 2003 · Terminated
The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
- Z-0476-03 · Zimmer Inc. · posted Jan 28, 2003 · Terminated
The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
- Z-0477-03 · Zimmer Inc. · posted Jan 28, 2003 · Terminated
The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
- Z-0438-03 · Roche Diagnostics Corp. · posted Jan 23, 2003 · Terminated
Air bubbles trapped in the PO2 electrode will cause falsely elevated patient test results.
- Z-0456-03 · Baxter Healthcare Corp. · posted Jan 23, 2003 · Terminated
Sterility questioned
- Z-0457-03 · Baxter Healthcare Corp. · posted Jan 23, 2003 · Terminated
Sterility questioned
- Z-0458-03 · Baxter Healthcare Corp. · posted Jan 23, 2003 · Terminated
Sterility questioned
- Z-0459-03 · Zimmer Inc. · posted Jan 23, 2003 · Terminated
Compression test results are not in accordance with device approval submission
- Z-0460-03 · Zimmer Inc. · posted Jan 23, 2003 · Terminated
Compression test results are not in accordance with device approval submission
- Z-0461-03 · Zimmer Inc. · posted Jan 23, 2003 · Terminated
Compression test results are not in accordance with device approval submission
- Z-0463-03 · Meridian Bioscience Inc · posted Jan 23, 2003 · Terminated
Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.
- Z-0464-03 · Meridian Bioscience Inc · posted Jan 23, 2003 · Terminated
Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.
- Z-0465-03 · Meridian Bioscience Inc · posted Jan 23, 2003 · Terminated
Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.
- Z-0466-03 · Sandhill Scientific, Inc · posted Jan 23, 2003 · Terminated
Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication.
- Z-0446-03 · RF Technologies, Inc. · posted Jan 16, 2003 · Terminated
In some cases the unit appears to be monitoring the patient, when in fact the alarm is silenced.
- Z-0447-03 · Becton Dickinson & Company · posted Jan 16, 2003 · Terminated
Insufficient amount of EDTA found within the tube causing clotting and erroneous platelet counts.
- Z-0448-03 · Baxter Healthcare Corp. · posted Jan 16, 2003 · Terminated
Leakage may occur at the inlet port
- Z-0449-03 · Baxter Healthcare Corp. · posted Jan 16, 2003 · Terminated
Leakage may occur at the inlet port
- Z-0450-03 · Baxter Healthcare Corp. · posted Jan 16, 2003 · Terminated
Leakage may occur at the inlet port
- Z-0451-03 · Baxter Healthcare Corp. · posted Jan 16, 2003 · Terminated
Leakage may occur at the inlet port
- Z-0452-03 · Baxter Healthcare Corp. · posted Jan 16, 2003 · Terminated
Leakage may occur at the inlet port
- Z-0453-03 · Baxter Healthcare Corp. · posted Jan 16, 2003 · Terminated
Leakage may occur at the inlet port
- Z-0439-03 · Sterile Surgical Systems Llc · posted Jan 14, 2003 · Terminated
An indicator inside the package did not change to indicate gowns were sterilized.
- Z-0440-03 · Sterile Surgical Systems Llc · posted Jan 14, 2003 · Terminated
An indicator inside the package did not change to indicate gowns were sterilized.
- Z-0441-03 · Sterile Surgical Systems Llc · posted Jan 14, 2003 · Terminated
An indicator inside the package did not change to indicate gowns were sterilized.
- Z-0442-03 · Sterile Surgical Systems Llc · posted Jan 14, 2003 · Terminated
An indicator inside the package did not change to indicate gowns were sterilized.
- Z-0443-03 · Sterile Surgical Systems Llc · posted Jan 14, 2003 · Terminated
An indicator inside the package did not change to indicate gowns were sterilized.
- Z-0444-03 · Safety Syringes Inc · posted Jan 14, 2003 · Terminated
Package integrity not validated. Sterility not assured.
- Z-0421-03 · Abbott Laboratories, Inc · posted Jan 11, 2003 · Terminated
Gas Springs supporting processing center cover lose pressure after repeated usage causing the cover to unexpectedly close.
- Z-0422-03 · Sunquest Information Systems · posted Jan 11, 2003 · Terminated
Software development logic defect.
- Z-0423-03 · Sunquest Information Systems · posted Jan 11, 2003 · Terminated
Software anomally.
- Z-0413-03 · Smith & Nephew, Inc. · posted Jan 9, 2003 · Terminated
Potential for non sterility as package tray does not contain aeration holes for ETO processing.
- Z-0414-03 · Kinetic Concepts, Inc · posted Jan 9, 2003 · Terminated
Electrical failure of the bed due to fluid egress into the junction box.
- Z-0415-03 · Beckman Coulter Inc · posted Jan 9, 2003 · Terminated
Software vote out logic changed. Erroneous white blood cell counts.
- Z-0416-03 · Beckman Coulter Inc · posted Jan 9, 2003 · Terminated
Software.
- Z-0417-03 · Beckman Coulter Inc · posted Jan 9, 2003 · Terminated
Software.
- Z-0418-03 · Beckman Coulter Inc · posted Jan 9, 2003 · Terminated
Software.
- Z-0419-03 · Medtronics Midas Rex · posted Jan 9, 2003 · Terminated
Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case.
- Z-0420-03 · Cardinal Health · posted Jan 9, 2003 · Terminated
Raw material used in the manufacture of catheters may contain a contaminant predisposing the catheter to become brittle, possibly breaking during use.
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.