Class 3 Device Recall Drainage Bag

• Date Initiated by Firm: January 12, 2011
• Date Posted: June 02, 2011
• Recall Status: Terminated on September 13, 2011
• Recall Number: Z-2405-2011
• Recall Event ID: 58664
• Product Classification: Bag, bile collecting - Product Code EXF
• Product: Drainage Bag, Model 600D, 600 mL, Single use, Ethylene Oxide sterilized, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005.; ; The Biliary Drainage Bag is used to aid with fluid drainage involving abscess, biliary and nephrostomy. Mechanical failure of this device would result in patient discomfort. This device is not life sustaining no life supporting. The medical device is not intended to be implanted. This medical device has surface contact with the patient. Improper use of this device could cause fluid back-up and result in invasive contact through the catheter. The drainage bag will be used in conjunction with a nephrostomy/biliary drainage catheter.
• Code Information: Lot numbers: 082943, 083375, 083302, 083232 and 100904.
• Recalling Firm/ Manufacturer: Remington Medical Inc.; 6830 Meadowridge Ct.; Alpharetta GA 30005
• For Additional Information Contact: Lynne Buchanan-Kopp; 770-888-8520
• Manufacturer Reason for Recall: There have been complaints of the Drainage Bags leaking from the outlet and the inlet port.
• FDA Determined Cause: Other
• Action: Remington Medical Inc.sent an Urgent Medical Device Recall letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine product subjec to recall. If they further distributed this product, they were to identify their customers and notify them at once of the product recall. Notification to their customers should include a copy of the recall notification letter. Customer were to receive a Return Authorization Form, reference RGA #600-D. For questions regarding this recall call 800-989-0057, ext. 213.
• Quantity in Commerce: 89294 units
• Distribution: Nationwide Distribution
• 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.