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Class 2 Device Recall CustomPak Surgical Packs |
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Date Initiated by Firm |
December 22, 2006 |
Date Posted |
March 01, 2007 |
Recall Status1 |
Terminated 3 on June 06, 2007 |
Recall Number |
Z-0560-2007 |
Recall Event ID |
37153 |
Product Classification |
Surgical Packs - Product Code HNN
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Product |
Alcon Custom-Pak¿, part #10975-02, 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 #649244H. |
Recalling Firm/ Manufacturer |
Alcon Laboratories, Inc 9965 Buffalo Speedway Houston TX 77054-1309
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Manufacturer Reason for Recall |
Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
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FDA Determined Cause 2 |
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 |
4 custom surgical packs. |
Distribution |
Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI. |
Total Product Life Cycle |
TPLC Device Report
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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.
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