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;
This recall has been terminated (originally issued July 24, 2003).
- 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
- Official Source
- View on FDA website ↗
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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