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U.S. Department of Health and Human Services

Class 2 Device Recall CUSTOMPAK

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  Class 2 Device Recall CUSTOMPAK see related information
Date Initiated by Firm May 16, 2014
Date Posted June 30, 2014
Recall Status1 Terminated 3 on December 09, 2014
Recall Number Z-1947-2014
Recall Event ID 68335
510(K)Number K880961  
Product Classification General surgery tray (kit) - Product Code LRO
Product Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04.

The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.
Code Information Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04 bearing Lot numbers 1584114H, 1577346H, 1595079H, 1589608H, 1595079H, 1585992H, 1580988H, 1585992H, and 1580492H.
Recalling Firm/
Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact Sue Whitfill
Manufacturer Reason
for Recall
Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle
FDA Determined
Cause 2
Employee error
Action Alcon sent an Urgert Market Withdrawal letter dated May 14, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory to determine if they have any affected product, place the affected product into quarantine to ensure it is not used, return the attached Response Form via fax to 817-302-4337 or email market.action@Alcon.com. Customers with questions were instructed to call 1-800-862-5266.
Quantity in Commerce 684 total (525 units in US)
Distribution Nationwide Distribution including North Carolina and Maine
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.
510(K) Database 510(K)s with Product Code = LRO and Original Applicant = ALCON LABORATORIES