—#42826

Product

BD Bard-Parker Special Surgeon''s Peridontia Blade, Sterile, Single Use

FDA product code: GES — Blade, Scalpel
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot # 4174460, Reorder # 371712

Why it was recalled

BD received reports of unit packages labeled with the incorrect blade edge. The incorrectly labeled unit packages indicate a '12' (single edged blade) is present, the actual blade present is a '12B' (double edged blade).

Root cause (FDA determination)

Other

Action the firm took

A urgent product recall was sent to distributors on 6/30/2005 by first class mail. End users were then identified and recall notifications were also sent to them. by first class mail.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Product was distributed to 9 distributors nationwide and then to end users.

Timeline

Recall initiated: 2005-06-30
Posted by FDA: 2005-11-16
Terminated: 2007-02-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #42826. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.