—#101559

Product

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

FDA product code: NNY — Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
Device class: Class 1
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Catalog number: A1300VA, Lot number: 02E1002552 Catalog number: A1300, Lot number: 02F1001467, 02F1002271, 02F1003283, 02G1000845 and 02G1001302.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern: Nationwide Distribution (USA) including the states of FL, GA, OH and SC.

Timeline

Recall initiated: 2011-06-27
Posted by FDA: 2011-07-15
Terminated: 2012-03-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #101559. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.