Z-0266-04

Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ, Cardinal Health, McGaw Park, IL 60085 USA

Name: Z-0266-04 Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ, Cardinal Health, McGaw Park, IL 60085 USA
Creator: Cardinal Health
Published: 2003-11-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2003-11-15 / Terminated / root cause: sterility

FDA source

Cardinal Health began a recall of Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ, Cardinal Health, McGaw Park, IL 60085 USA on 2003-11-15. The reason FDA records is "The Namic Angiography Kit attached to the outside top of the Custom Sterile Pack is not sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0266-04
Status: Terminated
Initiated: 2003-11-15
Posted: 2003-12-24
Terminated: 2005-10-20
Recalling firm: Medtronic, Inc.
Product: Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ, Cardinal Health, McGaw Park, IL 60085 USA
Product code: HAP
Reason for recall: The Namic Angiography Kit attached to the outside top of the Custom Sterile Pack is not sterile.
Root cause tag: sterility
FDA root cause: Other
Action: Recalled by salesman visit on 11/15/03 and follow-up faxed letter dated 11/18/03. The hospital was instructed to inspect their inventory for the affected catalog number and work order numbers, segregating them and placing the provided warning labels on the pack. The warnijng labels instruct the user not to use the Namic Angiography Kit attached to the pack and return the kit to Cardinal Health.
Quantity in commerce: 1,083 kits
Distribution: Georgia, Alabama
Product codes and lots: catalog number SAN25CCEAQ, lot numbers 548727, 548723, 544906, 542967, 542966

Product code HAP

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)