—#27986

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;

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Catalog SOP11MEMMD, Sterile Minor Extremity Pack, Mfg date 5/20/03, Exp date 11/01/04, order 101449;

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Cardinal Health
Address: 1500 Waukegan Rd, Bldg K, Mcgaw Park, Illinois 60085-6787

Distribution

Distribution pattern: New Jersey, Tennessee, Missouri and Minnesota

Timeline

Recall initiated: 2003-06-27
Posted by FDA: 2003-07-24
Terminated: 2005-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #27986. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.