—#34454

Product

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 product code: GBX — Catheter, Irrigation
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: catalog #SU130-1000, lots 1040877, 1040879, 1040991, 1040992

Why it was recalled

The products labeled as sterile are not sterile.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Cardinal Health
Address: 1430 Waukegan Rd, McGaw Park, Illinois 60085

Distribution

Distribution pattern: Florida, Arizona, New Jersey and Canada

Timeline

Recall initiated: 2004-07-28
Posted by FDA: 2004-08-25
Terminated: 2005-02-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34454. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.