Date Initiated by Firm |
June 27, 2003 |
Date Posted |
July 24, 2003 |
Recall Status1 |
Terminated 3 on September 22, 2005 |
Recall Number |
Z-1020-03 |
Recall Event ID |
26609 |
Product Classification |
General Surgery Tray - Product Code LRO
|
Product |
Custom Sterile Surgical Procedure Packs; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; see code information for details. The product packaging consists of a vented polybag with a label insert inside the polybag. Catalog SOP11MEMMD, Sterile Minor Extremity Pack, Mfg date 5/20/03, Exp date 11/01/04, order 101449; |
Code Information |
Catalog SOP11MEMMD, Sterile Minor Extremity Pack, Mfg date 5/20/03, Exp date 11/01/04, order 101449; |
Recalling Firm/ Manufacturer |
Cardinal Health 1500 Waukegan Rd, Bldg K Mcgaw Park IL 60085-6787
|
For Additional Information Contact |
Quality Systems Professional Services 800-292-9332
|
Manufacturer Reason for Recall |
The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.
|
FDA Determined Cause 2 |
Other |
Action |
The customers who ordered the custom packs were notified of the theft of the unsterilized packs via letter dated 6/27/03, sent via Airborne Express. The accounts were requested to inspect their inventory for the affected catalog numbers and order/lot numbers, and segregate any of the product found for return and replacement. |
Quantity in Commerce |
1242 packs total - all five kits |
Distribution |
New Jersey, Tennessee, Missouri and Minnesota |
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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