Custom Sterile Surgical Procedure Packs; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; see code informati
FDA device recall Z-1020-03 · posted 2003-07-24 · Terminated
Recall details
- Recalling firm
- Cardinal Health
- Reason for recall
- The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 1242 packs total - all five kits
- Distribution
- New Jersey, Tennessee, Missouri and Minnesota
- Date initiated
- 2003-06-27
- Date posted
- 2003-07-24
- Date terminated
- 2005-09-22
- Location
- Mcgaw Park, IL
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