Jackson-Pratt Reservoir, 400 mL suction reservoir; a sterile, single use only, Rx device used as a component of the wound drain system, individually packaged, 10 reservoirs per case; catalog #SU130-1000; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA
- Company
- Cardinal Health
- Recall Initiated
- July 28, 2004
- Posted
- August 25, 2004
- Terminated
- February 10, 2005
- Recall Number
- Z-1407-04
- Quantity
- 60 cases
- Firm Location
- McGaw Park, IL
Reason for Recall
The products labeled as sterile are not sterile.
Distribution
Florida, Arizona, New Jersey and Canada
Lot / Code Info
catalog #SU130-1000, lots 1040877, 1040879, 1040991, 1040992
Root Cause
Other
Action Taken
The accounts were telephoned on 7/28/04 and sent follow-up letters on the same date. They were informed that affected lots of products were not sterile, and were requested to inspect their inventory and segregate the product for return to Cardinal Health. The accounts were instructed to call 800-635-6021 for product return and instructions on how to obtain credit and replacement product.
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