RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: Th
FDA device recall Z-0565-2016 · posted 2015-12-31 · Terminated
Recall details
- Recalling firm
- RenovoRx, Inc.
- Reason for recall
- Incorrect version of Instructions for Use were shipped to two US customers.
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- MJN
- Quantity affected
- 11 units
- Distribution
- US Distribution to the states of : CA and FL.
- Date initiated
- 2015-11-25
- Date posted
- 2015-12-31
- Date terminated
- 2016-02-29
- Location
- Los Altos, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RENOVOCATH RC120 (K141175) | Renovorx, Inc. | 2014-10-24 |