Z-0058-2008

Remington Medical, Inc, (RMI) -- Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number...

Name: Z-0058-2008 Remington Medical, Inc, (RMI) -- Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number...
Creator: Remington Medical Inc.
Published: 2007-07-23
License: https://open.fda.gov/license/

Remington Medical / initiated 2007-07-23 / Terminated / root cause: manufacturing process

FDA source

Remington Medical Inc. began a recall of Remington Medical, Inc, (RMI) -- Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml Disposible Urinary Leg Bag (Order... on 2007-07-23. The reason FDA records is "Sterility, inadequate -- Pathway may not be sterile as labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0058-2008
Status: Terminated
Initiated: 2007-07-23
Posted: 2007-10-23
Terminated: 2009-04-06
Recalling firm: Remington Medical
Product: Remington Medical, Inc, (RMI) -- Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml Disposible Urinary Leg Bag (Order number 1000-D) -- Sterile Fluid Path, For Single Use Only, Remington Medical, Inc., Alpharetta, GA 30005.
Product code: EXF Bag, Bile Collecting
Reason for recall: Sterility, inadequate -- Pathway may not be sterile as labeled.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified by Urgent Recall Letter (dated 07/23/07) via fax from 07/24/2007 through 07/27/2007. They were instructed to quarantine all affected product in inventory. If product was distributed they were instructed to identify their customers and notify them of the recall via copy of the notification letter.
Quantity in commerce: 45,000 units
Distribution: Nationwide Distribution -- including states of AL, AR, AZ, CA, CO, CT, GA, HI, IL, IN, KS, KY, MD, MI, MT, NB, NC, OH, NY, PA, RI, TN, WA, WV, and WY.
Product codes and lots: Lot # 20070423 (500-D), and Lot #20070420 (1000-D)

Product code EXF

K990428Class IIDrainage BagRemington Medical, Inc. / cleared 1999-08-12

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)