Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ, Cardinal Health, McGaw Park, IL 60085 USA
FDA device recall Z-0266-04 · posted 2003-12-24 · Terminated
Recall details
- Recalling firm
- Cardinal Health
- Reason for recall
- The Namic Angiography Kit attached to the outside top of the Custom Sterile Pack is not sterile.
- Action taken
- 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
- Status
- Terminated
- Product code
- HAP
- Quantity affected
- 1,083 kits
- Distribution
- Georgia, Alabama
- Date initiated
- 2003-11-15
- Date posted
- 2003-12-24
- Date terminated
- 2005-10-20
- Location
- McGaw Park, IL
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