FDA Enforcement
Class II
Terminated
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.
Recall: Z-0565-2016
·
Reported January 6, 2016
Enforcement
- Recall Number
- Z-0565-2016
- Event ID
- 72810
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- RenovoRx, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 6, 2016
- Initiation Date
- November 25, 2015
- Classification Date
- December 31, 2015
- Termination Date
- February 29, 2016
- Address
- 4546 El Camino Real Ste 282, N/A, Los Altos, CA, 94022-1068, United States
Description
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.
Reason
Incorrect version of Instructions for Use were shipped to two US customers.
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.
Distribution
US Distribution to the states of : CA and FL.
Quantity
11 units