FDA Medical Device Recalls (openFDA)
Teleflex Medical: Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. Used for urine collection.
- Recall number
- Z-2831-2011
- Recalling firm
- Teleflex Medical
- Product
- Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. Used for urine collection.
- Status
- Terminated
- Initiated
- 2011-06-27
- Posted
- 2011-07-15
- Terminated
- 2012-03-20
- Reason
- The Kit contains Skin-Prep protective wipes that were manufactured by the Triad Group and are being recalled by Smith & Nephew, due to possible bacterial contamination.
- Root cause
- Other
- Action
- Teleflex Medical sent an "Urgent Medical Device Recall Notification" dated June 27, 2011 to all affected customers. The firm provided recommendations including all affected product be discontinued and quarantined. A Recall Acknowledgement Form was provided to be completed and returned. If the product was further distributed, they were urged to contact their customers and communicate the recall. For additional information please contact Customer Service at 866-246-6990 or your local sales representative.
- Quantity
- 6880 units (total for both products)
- Distribution
- Nationwide Distribution (USA) including the states of FL, GA, OH and SC.
- Lot, serial or model codes
- Catalog number: A1300VA, Lot number: 02E1002552 Catalog number: A1300, Lot number: 02F1001467, 02F1002271, 02F1003283, 02G1000845 and 02G1001302.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NNY
- Firm FEI
- 3005747797
- Firm city
- Durham
- Firm state
- NC
- 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