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.
This recall has been terminated (originally issued June 9, 2014).
- Company
- Teleflex Medical
- Recall Initiated
- May 21, 2014
- Posted
- June 9, 2014
- Terminated
- November 23, 2015
- Recall Number
- Z-1732-2014
- Quantity
- 1000 eaches
- Firm Location
- Research Triangle Park, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Product was packaged with a straight catheter rather than the correct coude (curved) catheter.
Distribution
US Distribution including the states of CA, FL, OH and OK.
Lot / Code Info
Product Code: ECK103, Lot number: 02A1402484
Root Cause
Mixed-up of materials/components
Action Taken
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.