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.
This recall has been terminated (originally issued December 31, 2015).
- Company
- Renovorx, Inc.
- Recall Initiated
- November 25, 2015
- Posted
- December 31, 2015
- Terminated
- February 29, 2016
- Recall Number
- Z-0565-2016
- Quantity
- 11 units
- Firm Location
- Los Altos, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect version of Instructions for Use were shipped to two US customers.
Distribution
US Distribution to the states of : CA and FL.
Lot / Code Info
Model number: MMRC120-DB-1111; Lot number: B2456974A; Expiry 2016-07. Lot B2457150A - all 72 units were either used or returned prior to initiation of recall.
Root Cause
Labeling Change Control
Action Taken
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.