Events

Recall of Device Recall Drainage Bag

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Remington Medical Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58664
  • Event Risk Class
    Class 3
  • Event Number
    Z-2405-2011
  • Event Initiated Date
    2011-01-12
  • Event Date Posted
    2011-06-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99852
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bag, bile collecting - Product Code EXF
  • 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.

Device

Device Recall Drainage Bag
  • Model / Serial
    Lot numbers: 082943, 083375, 083302, 083232 and 100904.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product 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.
  • Manufacturer
    Remington Medical Inc.

Manufacturer

Remington Medical Inc.
  • Manufacturer Address
    Remington Medical Inc., 6830 Meadowridge Ct., Alpharetta GA 30005
  • Manufacturer Parent Company (2017)
    Remington Medical, Inc.
  • Source
    USFDA