FDA Recall
Terminated
Alcon Custom-Pak, part #2638-17, 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.
Recall: Z-0561-2007
·
Initiated December 22, 2006
Recall
- Recall Number
- Z-0561-2007
- Event Number
- 37153
- Firm
- Alcon Laboratories, Inc
- FEI Number
- 1000117501
- Product Code
- HNN
- Status
- Terminated
- Root Cause
- Other
- Initiated
- December 22, 2006
- Posted
- March 1, 2007
- Terminated
- June 6, 2007
- Address
- 9965 Buffalo, Speedway Houston, TX, 77054-1309
Description
Alcon Custom-Pak, part #2638-17, 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.
Reason
Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
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.
Distribution
Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.
Quantity
27 custom surgical packs.