BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2405-2011 · Initiated January 12, 2011

    Recall

    Recall Number
    Z-2405-2011
    Event Number
    58664
    Firm
    Remington Medical Inc.
    FEI Number
    1000132370
    Product Code
    EXF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 12, 2011
    Posted
    June 2, 2011
    Terminated
    September 13, 2011
    Address
    6830 Meadowridge Ct., Alpharetta, GA, 30005

    Description

    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.

    Reason

    There have been complaints of the Drainage Bags leaking from the outlet and the inlet port.

    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.

    Distribution

    Nationwide Distribution

    Quantity

    89294 units