Class 2 Device Recall JacksonPratt Reservoir

• Date Initiated by Firm: July 28, 2004
• Date Posted: August 25, 2004
• Recall Status: Terminated on February 10, 2005
• Recall Number: Z-1407-04
• Recall Event ID: 29739
• Product Classification: Catheter, Irrigation - Product Code GBX
• 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
• Code Information: catalog #SU130-1000, lots 1040877, 1040879, 1040991, 1040992
• Recalling Firm/ Manufacturer: Cardinal Health; 1430 Waukegan Rd; McGaw Park IL 60085
• For Additional Information Contact: Cardinal Health Quality Systems ; 800-292-9332
• Manufacturer Reason for Recall: The products labeled as sterile are not sterile.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 60 cases
• Distribution: Florida, Arizona, New Jersey and Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.