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U.S. Department of Health and Human Services

Class 2 Device Recall Urine Collection Kit

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 Class 2 Device Recall Urine Collection Kitsee related information
Date Initiated by FirmApril 30, 2003
Date PostedMay 22, 2003
Recall Status1 Terminated 3 on November 14, 2003
Recall NumberZ-0859-03
Recall Event ID 26196
Product Classification Bag, Urine Collection, Leg, For External Use, Sterile - Product Code FAQ
ProductGENT-L-KARE STERILE MID-STREAM URINE COLLECTOR
Code Information Catalog # 4150 , Lot number 037667A2. 
Recalling Firm/
Manufacturer		 Medegen Medical Products, LLC
11060 Irma Drive
Northglenn CO 80233
For Additional Information ContactJanet A. Prieur
303-457-2400 Ext. 128
Manufacturer Reason
for Recall		Finished products were not sterilized.
FDA Determined
Cause 2		Other
ActionMedegen has notified all direct accounts by certified mail on 4/30/03.
DistributionNationwide domestic distribution. Foreign distribution to Canada and Saudia Arabia. No government and military consignees.
Total Product Life CycleTPLC 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.
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