FDA Recall
Terminated
Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ, Cardinal Health, McGaw Park, IL 60085 USA
Recall: Z-0266-04
·
Initiated November 15, 2003
Recall
- Recall Number
- Z-0266-04
- Event Number
- 27757
- Firm
- Cardinal Health
- FEI Number
- 3001236905
- Product Code
- HAP
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 15, 2003
- Posted
- December 24, 2003
- Terminated
- October 20, 2005
- Address
- 1430 Waukegan Rd, McGaw Park, IL, 60085
Description
Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ, Cardinal Health, McGaw Park, IL 60085 USA
Reason
The Namic Angiography Kit attached to the outside top of the Custom Sterile Pack is not sterile.
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.
Distribution
Georgia, Alabama
Quantity
1,083 kits