Recall Z-0565-2016 ยท MJN Catheter, Intravascular Occluding, Temporary
RenovoRx, Inc.
RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system.
| Date | Dec 31, 2015 (initiated Nov 25, 2015) |
| Status | Terminated |
| Reason | Incorrect version of Instructions for Use were shipped to two US customers. |
| Root cause | Labeling Change Control |
| Action | RenovoRx notified customers by phone and by mail of this issue. This notification requests that the customers remove the affected product from their inventory and remove and replace the incorrect Instructions for Use with the correct Instructions for Use provided by RenovoRx. The customers are requested to return the incorrect Instruction for Use to RenovoRx for disposition and are requested to complete a Recall Confirmation Form enclosed to document the completion of the requested Correction. For further questions, please call (650) 284-4433. |
| Quantity | 11 units |
| Distribution | US Distribution to the states of : CA and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141175 | RENOVOCATH RC120 Renovorx, Inc., Oct 24, 2014 |