Z-1020-03

Custom Sterile Surgical Procedure Packs; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; see...

Name: Z-1020-03 Custom Sterile Surgical Procedure Packs; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; see...
Creator: Cardinal Health
Published: 2003-06-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2003-06-27 / Terminated / root cause: labeling and UDI

FDA source

Cardinal Health began a recall of Custom Sterile Surgical Procedure Packs; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; see code information for details. The product packaging... on 2003-06-27. The reason FDA records is "The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1020-03
Status: Terminated
Initiated: 2003-06-27
Posted: 2003-07-24
Terminated: 2005-09-22
Recalling firm: Medtronic, Inc.
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;
Product code: LRO General Surgery Tray
Reason for recall: The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: 1242 packs total - all five kits
Distribution: New Jersey, Tennessee, Missouri and Minnesota
Product codes and lots: Catalog SOP11MEMMD, Sterile Minor Extremity Pack, Mfg date 5/20/03, Exp date 11/01/04, order 101449;

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)