Recalls / —

—#28498

Product

Catalog SBA61MJSFH, Sterile Laparotomy Pack, Mfg date 5/21/03, order 101438;

FDA product code

LRO — General Surgery Tray

Device class

Class 2

Medical specialty

General, Plastic Surgery

Affected lot / code info

Catalog SBA61MJSFH, Sterile Laparotomy Pack, Mfg date 5/21/03, order 101438;

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 #28498. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.