RecallDepth

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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