Z-2393-2011

URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin Protective Wipe Product ID...

Name: Z-2393-2011 URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin Protective Wipe Product ID...
Creator: Covidien LP
Published: 2011-04-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2011-04-29 / Terminated / root cause: sterility

FDA source

Covidien LP began a recall of URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin Protective Wipe Product ID: 8884732500 Intended use: Collector urine from male... on 2011-04-29. The reason FDA records is "A component of the Uri-Drain device recalled the Skin-Prep (manufactured by H&P Industries-Triad) a protective wipe due to bacterial contamination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2393-2011
Status: Terminated
Initiated: 2011-04-29
Posted: 2011-05-27
Terminated: 2015-05-29
Recalling firm: Medtronic, Inc.
Product: 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
Product code: KNX Collector, Urine, (And Accessories) For Indwelling Catheter
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
Root cause tag: sterility
FDA root cause: Other
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.
Quantity in commerce: 52128 units
Distribution: Worldwide distribution: USA (nationwide) and countries including: Canada and Bermuda.
Product codes and lots: Lot Numbers: 016671464 019371364 022372464 023072264 027272564 032972964 034172164 100370964 103170664 106855364

Product code KNX

K770789Class IIUri-Drain Combo Kit for Male IncontinencChesebrough-Pond'S U.S.A. Co. / cleared 1977-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)