FDA Device

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.

Hazard

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

What You Should Do

Remedy

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.

Products