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Terminated

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

FDA Recall Z-0266-04 · Posted 2003-12-24

Recalling FirmCardinal Health
Recall StatusTerminated
Product CodeHAP
Date Initiated2003-11-15
Date Terminated2005-10-20
Product Quantity1,083 kits

Reason for Recall

The Namic Angiography Kit attached to the outside top of the Custom Sterile Pack is not sterile.

Firm 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.

Root Cause

Other

Distribution Pattern

Georgia, Alabama

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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