—#127390

Product

RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.

FDA product code: KOD — Catheter, Urological
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K000070
Affected lot / code info: Product Code: ECK103, Lot number: 02A1402484

Why it was recalled

Product was packaged with a straight catheter rather than the correct coude (curved) catheter.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Teleflex Medical sent an Urgent Medical Device Recall Notification dated May 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any of the affected product in stock. They were to complete and return the enclosed Recall Acknowledgement Form via fax to Teleflex Medical. Upon receipt, they will be contacted by a Customer Service Representative with instructions for the return of the product to Teleflex Medical. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr., Research Triangle Park, North Carolina 27709

Distribution

Distribution pattern: US Distribution including the states of CA, FL, OH and OK.

Timeline

Recall initiated: 2014-05-21
Posted by FDA: 2014-06-09
Terminated: 2015-11-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127390. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.