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U.S. Department of Health and Human Services

Class 2 Device Recall Remington Medical, Inc, (RMI) Urinary Drainage Bag

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  Class 2 Device Recall Remington Medical, Inc, (RMI) Urinary Drainage Bag see related information
Date Initiated by Firm July 23, 2007
Date Posted October 23, 2007
Recall Status1 Terminated 3 on April 06, 2009
Recall Number Z-0058-2008
Recall Event ID 44938
510(K)Number K990428  
Product Classification Urinary Drainage Bag - Product Code EXF
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.
Code Information Lot # 20070423 (500-D), and Lot #20070420 (1000-D)
Recalling Firm/
Remington Medical Inc.
6830 Meadowridge Ct.
Alpharetta GA 30005
For Additional Information Contact Cindy Croft
Manufacturer Reason
for Recall
Sterility, inadequate -- Pathway may not be sterile as labeled.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EXF and Original Applicant = REMINGTON MEDICAL, INC.