Z-2831-2011

Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. Used for urine...

Name: Z-2831-2011 Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. Used for urine...
Creator: Teleflex Medical
Published: 2011-06-27
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2011-06-27 / Terminated / root cause: sterility

FDA source

Teleflex Medical began a recall of Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. Used for urine collection on 2011-06-27. The reason FDA records is "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". 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-2831-2011
Status: Terminated
Initiated: 2011-06-27
Posted: 2011-07-15
Terminated: 2012-03-20
Recalling firm: Teleflex Medical
Product: Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. Used for urine collection.
Product code: NNY Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
Reason for recall: 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 tag: sterility
FDA 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 in commerce: 6880 units (total for both products)
Distribution: Nationwide Distribution (USA) including the states of FL, GA, OH and SC.
Product codes and lots: Catalog number: A1300VA, Lot number: 02E1002552 Catalog number: A1300, Lot number: 02F1001467, 02F1002271, 02F1003283, 02G1000845 and 02G1001302.

Product code NNY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)