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.
FDA Recall Z-2405-2011 · Posted 2011-06-02
Recalling FirmRemington Medical Inc.
Recall StatusTerminated
Product CodeEXF
Date Initiated2011-01-12
Date Terminated2011-09-13
Product Quantity89294 units
Reason for Recall
There have been complaints of the Drainage Bags leaking from the outlet and the inlet port.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.