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Terminated

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

FDA Recall Z-1407-04 · Posted 2004-08-25

Recalling FirmCardinal Health
Recall StatusTerminated
Product CodeGBX
Date Initiated2004-07-28
Date Terminated2005-02-10
Product Quantity60 cases

Reason for Recall

The products labeled as sterile are not sterile.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Florida, Arizona, New Jersey and Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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