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U.S. Department of Health and Human Services

Class 2 Device Recall URIDRAIN Standard Male External Catheter

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 Class 2 Device Recall URIDRAIN Standard Male External Cathetersee related information
Date Initiated by FirmApril 29, 2011
Date PostedMay 27, 2011
Recall Status1 Terminated 3 on May 29, 2015
Recall NumberZ-2392-2011
Recall Event ID 58665
510(K)NumberK770789 
Product Classification Collector, urine, (and accessories) for indwelling catheter - Product Code KNX
ProductURI-DRAIN Medium Male External Catheter With Two-Sided Adhesive Strap and Skin Protective Wipe Product ID: 8884732000 Intended use: Collector urine from male patients (and accessories) for indwelling catheter
Code Information Lot Numbers: 030772764 109555264
FEI Number 1282497
Recalling Firm/
Manufacturer		 Covidien LP
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information ContactJim Welsh
508-261-8000
Manufacturer Reason
for Recall		A component of the Uri-Drain device recalled the Skin-Prep (manufactured by H&P Industries-Triad) a protective wipe due to bacterial contamination
FDA Determined
Cause 2		Other
ActionThe firm, Covidien, sent an "URGENT PRODUCT RECALL" letter dated April 29, 2011 to its customers via US Postal Service. The letter described the product, problem and actions to be taken. The customers were instructed to immediately stop using the product, place in quarantine, and return any inventory. Distributors are requested to notify their customers. All customers are required to respond to the notice regardless of remaining inventory. Responses will be tracked for follow-up and effectiveness checks. For Customer Service questions regarding the recall please telephone: 1-800-962-9888 option 1 (weekdays, 8am to 6:30pm Eastern) and email to: sdfeedback@covidien.com. Should you have any medical questions concerning this recall, please call 508-261-6393.
Quantity in Commerce5760 units
DistributionWorldwide distribution: USA (nationwide) and countries including: Canada and Bermuda.
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.
510(K) Database510(K)s with Product Code = KNX
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