Recalls / —

—#30475

Product

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

FDA product code

HAP

Affected lot / code info

catalog number SAN25CCEAQ, lot numbers 548727, 548723, 544906, 542967, 542966

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Cardinal Health

Address

1430 Waukegan Rd, McGaw Park, Illinois 60085

Distribution

Distribution pattern

Georgia, Alabama

Timeline

Recall initiated

2003-11-15

Posted by FDA

2003-12-24

Terminated

2005-10-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #30475. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.