Recall Z-0564-2007 ยท HNN Knife, Ophthalmic
Alcon Laboratories, Inc
Alcon Custom-Pak, part #11148-02, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
| Date | Mar 1, 2007 (initiated Dec 22, 2006) |
| Status | Terminated |
| Reason | Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs. |
| Root cause | Other |
| Action | Customers notified of recall via phone on 12/22/06, with follow-up fax and letter. A revised notification was made via phone and fax to each customer on 12/26/06. Customers instructed not to use blades and to return blades for a replacement. Recall to the user/hospital level. |
| Quantity | 65 custom surgical packs. |
| Distribution | Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.