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.
FDA Recall Z-0564-2007 · Posted 2007-03-01
Recalling FirmAlcon Laboratories, Inc
Recall StatusTerminated
Product CodeHNN
Date Initiated2006-12-22
Date Terminated2007-06-06
Product Quantity65 custom surgical packs.
Reason for Recall
Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
Firm 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.
Root Cause
Other
Distribution Pattern
Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.