Remington Medical…

Date posted by the FDA

Oct. 23, 2007

Status

Terminated

Filed by

Remington Medical Inc.

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.

Reason

Sterility, inadequate -- Pathway may not be sterile as labeled.

Distribution pattern

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.

Quantity

45,000 units

Codes and lots

Lot # 20070423 (500-D), and Lot #20070420 (1000-D)

Recall started

July 23, 2007

Device type

Bag, Bile Collecting

Root cause (FDA)

Process control

What the company told customers

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.

Recall number

Z-0058-2008

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0058-2008. The agency record governs; check it and the company before acting.