Recall Z-1732-2014 ยท KOD Catheter, Urological
Teleflex Medical
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.
| Date | Jun 9, 2014 (initiated May 21, 2014) |
| Status | Terminated |
| Reason | Product was packaged with a straight catheter rather than the correct coude (curved) catheter. |
| Root cause | Mixed-up of materials/components |
| Action | 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 t |
| Quantity | 1000 eaches |
| Distribution | US Distribution including the states of CA, FL, OH and OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000070 | FLOCATH Rusch Intl., Feb 18, 2000 |