Recall Z-0152-06 ยท GES Blade, Scalpel
Becton Dickinson & Company
BD Bard-Parker Special Surgeon''s Peridontia Blade, Sterile, Single Use
| Date | Nov 16, 2005 (initiated Jun 30, 2005) |
| Status | Terminated |
| Reason | 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 | Other |
| Action | 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. |
| Quantity | 11,900 units were distributed |
| Distribution | Product was distributed to 9 distributors nationwide and then to end users. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.