Device product
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.
Z-0565-2016
Product summary
- Firm
- RenovoRx, Inc.
- Event
- Event 72810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 units
- Official record key
device-enforcement:Z-0565-2016
Official wording
Reason: Incorrect version of Instructions for Use were shipped to two US customers.
Code information: 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 pattern: US Distribution to the states of : CA and FL.
Derived failure modes
-
Unknown
Incorrect version of Instructions for Use were shipped to two US customers.