Z-2405-2011

Drainage Bag, Model 600D, 600 mL, Single use, Ethylene Oxide sterilized, Remington Medical, Inc., 6830...

Name: Z-2405-2011 Drainage Bag, Model 600D, 600 mL, Single use, Ethylene Oxide sterilized, Remington Medical, Inc., 6830...
Creator: Remington Medical Inc.
Published: 2011-01-12
License: https://open.fda.gov/license/

Remington Medical / initiated 2011-01-12 / Terminated

FDA source

Remington Medical Inc. began a recall of Drainage Bag, Model 600D, 600 mL, Single use, Ethylene Oxide sterilized, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005. The Biliary... on 2011-01-12. The reason FDA records is "There have been complaints of the Drainage Bags leaking from the outlet and the inlet port". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2405-2011
Status: Terminated
Initiated: 2011-01-12
Posted: 2011-06-02
Terminated: 2011-09-13
Recalling firm: Remington Medical
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.
Product code: EXF Bag, Bile Collecting
Reason for recall: There have been complaints of the Drainage Bags leaking from the outlet and the inlet port.
FDA root 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
Product codes and lots: Lot numbers: 082943, 083375, 083302, 083232 and 100904.

Product code EXF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)