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Terminated

Catalog SBA35GSMOG, Sterile General Surgery Pack, Mfg date 5/21/03, order 101467;

FDA Recall Z-1024-03 · Posted 2003-07-24

Recalling FirmCardinal Health
Recall StatusTerminated
Product CodeLRO
Date Initiated2003-06-27
Date Terminated2005-09-22

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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