Recall Z-1075-05 ยท GES Blade, Scalpel
Becton Dickinson & Company
BD #11 Bard Parker Scalpel. A general use surgical blade, frequently used for ''stab incisions''. A non sterile, disposable, stainless steel blade. Reorder Number 371631.
| Date | Aug 3, 2005 (initiated Apr 19, 2005) |
| Status | Terminated |
| Reason | A small percentage of scalpels exhibited a 'double blade' condition. |
| Root cause | Other |
| Action | Letters were sent to all customers and all customers have also been contacted by phone. Letters were sent on 4/49/2005. |
| Quantity | 48000 units |
| Distribution | The scalpels were distributed to kit manufacturers. These include: Cardinal Health, 1300 Waukegan Road, McGaw Park, Il 60085; Bard Health Care, 201 West Anaya Road, Hidalgo, TX 78577; Edwards Lifesciences, 6864 South 300 West, Salt Lake City, UT 84047; Avid Medical, 900 Westmount Dr., James City, V |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.