Recalls / —
—#55336
Product
Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
- FDA product code
- GES — Blade, Scalpel
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- Reorder number 371211; Lot Number 02028051 -Stainless Steel; Reorder number 371211; Lot Number 02028090- Stainless Steel.
Why it was recalled
Complaints received of rust on the blades of BD Bard-Parker Surgical blades.
Root cause (FDA determination)
Packaging change control
Action the firm took
Urgent recall letters were sent out 8/10/2007 via UPS second day air.
Recalling firm
- Firm
- Becton Dickinson & Company
- Address
- 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2007-08-10
- Posted by FDA
- 2007-10-02
- Terminated
- 2008-03-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #55336. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.