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Class 2 Device Recall Remington Medical, Inc, (RMI) Urinary Drainage Bag |
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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
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Product Classification |
Urinary Drainage Bag - Product Code EXF
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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/ Manufacturer |
Remington Medical Inc. 6830 Meadowridge Ct. Alpharetta GA 30005
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For Additional Information Contact |
Cindy Croft 770-888-8520
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Manufacturer Reason for Recall |
Sterility, inadequate -- Pathway may not be sterile as labeled.
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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
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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.
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510(K) Database |
510(K)s with Product Code = EXF and Original Applicant = REMINGTON MEDICAL, INC.
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