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Class 2 Device Recall Rusch/MMG Urinary Catheterization System, 14 Fr |
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Date Initiated by Firm |
July 11, 2005 |
Date Posted |
August 04, 2005 |
Recall Status1 |
Terminated 3 on November 14, 2007 |
Recall Number |
Z-1083-05 |
Recall Event ID |
32627 |
510(K)Number |
K010420
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Product Classification |
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) - Product Code FCM
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Product |
Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and underpad; 100 kits per box; Rusch, 2450 Meadowbrook Pwy, Duluth, GA 30096, Assembled in Mexico from U.S. Components; product number RLA-142-3 |
Code Information |
product number RLA-142-3, lot 002990-6, exp. 2007/03 and lot 002990-7, exp. 2007/02; the recall was expanded on 11/15/05 to include lot numbers 004622-3 and 004622-4 |
Recalling Firm/ Manufacturer |
Teleflex Medical 2345 Waukegan Rd Ste 120 Bannockburn IL 60015-1580
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For Additional Information Contact |
Ms. Julie McDowell 610-948-2836
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Manufacturer Reason for Recall |
There is a lack of assurance of sterility for parts of these lots of product.
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FDA Determined Cause 2 |
Other |
Action |
Teleflex Medical sent their customers recall letters dated July 11, 2005 via UPS, 2 Day Delivery, on July 13, 2005. The customers were informed that there were documentation discrepancies for the two lots which impact the level of assurance that all of the units are sterile, and were instructed to remove and quarantine all affected product immediately and return the product to Teleflex Medical at Research Triangle Park, NC. Any questions were directed to Dan Daily at 1-800-334-9751, ext. 4029.
The recall was extended to include the two additional lots by letter dated 11/15/05. The customers were informed that there were documentation discrepancies for the two lots which impact the level of assurance that all of the units are sterile, and were instructed to remove and quarantine all affected product immediately and return the product to Teleflex Medical at Durham, NC. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
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Quantity in Commerce |
95,800 units |
Distribution |
Nationwide |
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 = FCM and Original Applicant = RUSCH, INC.
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