URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin Protective Wipe Product ID: 8884732500 Intended use: Collector urine from male patients (and accessories) for indwelling catheter
FDA Recall Z-2393-2011 · Posted 2011-05-27
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Recalling FirmCovidien LP
Recall StatusTerminated
Product CodeKNX
Date Initiated2011-04-29
Date Terminated2015-05-29
Product Quantity52128 units
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
Firm Action
The 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: [email protected]. Should you have any medical questions concerning this recall, please call 508-261-6393.
Root Cause
Other
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries including: Canada and Bermuda.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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