Remington Medical Inc.: 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.

Recall number

Z-0058-2008

Recalling firm

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.

Status

Terminated

Initiated

2007-07-23

Posted

2007-10-23

Terminated

2009-04-06

Reason

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

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

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.

Lot, serial or model codes

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

510(k) numbers

["K990428"]

PMA numbers

not on file

Product code

EXF

Firm FEI

1000132370

Firm city

Alpharetta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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