Medical device recalls: December 2002
The FDA posted 23 medical device recall records in December 2002, from 20 recall events by 16 companies. 23 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
- Ciba Vision Corporation · 2 events, 2 records
- Siemens Medical Systems Inc · 2 events, 2 records
- Ansell Healthcare Inc · 1 event, 2 records
- Howmedica Osteonics Corp · 1 event, 2 records
- River City Drug · 1 event, 2 records
- Abbott Laboratories, Inc. · 1 event, 1 record
- Action Products Incorporated · 1 event, 1 record
FDA root cause
- Other · 23
Not yet classified (23)
The FDA has posted these records but has not published a class for them yet.
- Z-0398-03 · River City Drug · posted Dec 31, 2002 · Terminated
Products labeled 'For Sale Outside The USA and Canada,' were being offered for sale in the U.S.
- Z-0399-03 · River City Drug · posted Dec 31, 2002 · Terminated
Products labeled 'For Sale Outside The USA and Canada,' were being offered for sale in the U.S.
- Z-0400-03 · My Cosmetics Inc · posted Dec 31, 2002 · Terminated
Products are being distributed from importer directly to retail outlets labeled 'for cosmetic use only'
- Z-0401-03 · Ansell Healthcare Inc · posted Dec 31, 2002 · Terminated
The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards
- Z-0402-03 · Ansell Healthcare Inc · posted Dec 31, 2002 · Terminated
The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards
- Z-0403-03 · Abbott Laboratories, Inc. · posted Dec 31, 2002 · Terminated
Use of glucose blood strips may provide false high results
- Z-0404-03 · Elan Diagnostics, Inc. · posted Dec 31, 2002 · Terminated
Potential for reporting lower than actual HDL (cholesterol) results due to low QC Recovery
- Z-0405-03 · Ciba Vision Corporation · posted Dec 31, 2002 · Terminated
Mislabeling
- Z-0348-03 · Bausch & Lomb Inc · posted Dec 19, 2002 · Terminated
Lenses labeled as -2.25 diopter contain -0.75 diopter lenses.
- Z-0349-03 · Howmedica Osteonics Corp · posted Dec 19, 2002 · Terminated
Hip Stem Fractures in the neck area.
- Z-0350-03 · Howmedica Osteonics Corp · posted Dec 19, 2002 · Terminated
Hip Stem Fractures in the neck area.
- Z-0341-03 · St Jude Medical · posted Dec 18, 2002 · Terminated
Potential loss of pacing function. Expansion of recalls Z-031-1 thru Z-036-1
- Z-0342-03 · Ciba Vision Corporation · posted Dec 18, 2002 · Terminated
Lenses were labeled with the wrong prescription.
- Z-0343-03 · Philips Medical Systems, Inc. Cardiac & Monitoring Systems · posted Dec 18, 2002 · Terminated
Defective energy switch may cause Defibrillator to turn off or charge to a different energy level than was selected.
- Z-0345-03 · Becton Dickinson & Co. · posted Dec 18, 2002 · Terminated
Microbiological media may exhibit No Growth or reduced colony size of Haemophilus species.
- Z-0346-03 · SSL Americas Inc. · posted Dec 18, 2002 · Terminated
Sulfur particles on the surface of gloves.
- Z-0347-03 · Siemens Medical Systems Inc · posted Dec 18, 2002 · Terminated
Set delay time for contrast injection exceeds 10 seconds, radiation release button is blocked.
- Z-0325-03 · Sunquest Information Systems · posted Dec 11, 2002 · Terminated
Interfacing software systems have inconsistent character recognition characteristics.
- Z-0319-03 · Sunquest Information Systems · posted Dec 5, 2002 · Terminated
Software coding error caused data formatting error.
- Z-0322-03 · Siemens Medical Systems Inc · posted Dec 5, 2002 · Terminated
Head holder cannot be properly secured on the table top.
- Z-0323-03 · Cordis Corporation · posted Dec 5, 2002 · Terminated
Field complaints of marker band spacing being out of spec.
- Z-0324-03 · Sunquest Information Systems · posted Dec 5, 2002 · Terminated
Software anomally - animal ranges, when desired on reports, are defaulting to human male ranges.
- Z-316/318-3 · Action Products Incorporated · posted Dec 5, 2002 · Terminated
Wheelchair seat component is defective.
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.