FDA Medical Device Recalls (openFDA)
Covidien LP: 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
- Recall number
- Z-2393-2011
- Recalling firm
- Covidien LP
- 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
- Status
- Terminated
- Initiated
- 2011-04-29
- Posted
- 2011-05-27
- Terminated
- 2015-05-29
- Reason
- 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
- 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: sdfeedback@covidien.com. Should you have any medical questions concerning this recall, please call 508-261-6393.
- Quantity
- 52128 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries including: Canada and Bermuda.
- Lot, serial or model codes
- Lot Numbers: 016671464 019371364 022372464 023072264 027272564 032972964 034172164 100370964 103170664 106855364
- 510(k) numbers
- ["K770789"]
- PMA numbers
- not on file
- Product code
- KNX
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28