Alcon Custom-Pak, part #11148-02, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repa
FDA device recall Z-0564-2007 · posted 2007-03-01 · Terminated
Recall details
- Recalling firm
- Alcon Laboratories, Inc
- Reason for recall
- Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HNN
- Quantity affected
- 65 custom surgical packs.
- Distribution
- Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.
- Date initiated
- 2006-12-22
- Date posted
- 2007-03-01
- Date terminated
- 2007-06-06
- Location
- Houston, TX
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