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;
FDA Recall Z-1020-03 · Posted 2003-07-24
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Recalling FirmCardinal Health
Recall StatusTerminated
Product CodeLRO
Date Initiated2003-06-27
Date Terminated2005-09-22
Product Quantity1242 packs total - all five kits
Reason for Recall
The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.
Firm 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.
Root Cause
Other
Distribution Pattern
New Jersey, Tennessee, Missouri and Minnesota
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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