Class 2 Device Recall CustomPak Surgical Packs

• Date Initiated by Firm: December 22, 2006
• Date Posted: March 01, 2007
• Recall Status: Terminated on June 06, 2007
• Recall Number: Z-0564-2007
• Recall Event ID: 37153
• Product Classification: Surgical Packs - Product Code HNN
• Product: 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.
• Code Information: Lot #632178H, 634400H and 642229H.
• Recalling Firm/ Manufacturer: Alcon Laboratories, Inc; 9965 Buffalo Speedway; Houston TX 77054-1309
• Manufacturer Reason for Recall: Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
• FDA Determined 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 in Commerce: 65 custom surgical packs.
• Distribution: Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.