RecallDepth

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;

Company
Cardinal Health
Recall Initiated
June 27, 2003
Posted
July 24, 2003
Terminated
September 22, 2005
Recall Number
Z-1020-03
Quantity
1242 packs total - all five kits
Firm Location
Mcgaw Park, IL

Reason for Recall

The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.

Distribution

New Jersey, Tennessee, Missouri and Minnesota

Lot / Code Info

Catalog SOP11MEMMD, Sterile Minor Extremity Pack, Mfg date 5/20/03, Exp date 11/01/04, order 101449;

Root Cause

Other

Action Taken

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.

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