Recall Z-0565-2016— RenovoRx, Inc.
Class II · Terminated
Class II FDA medical device recall by RenovoRx, Inc., initiated 2015-11-25, terminated 2016-02-29. It names one FDA 510(k) clearance: K141175. 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.. Reason: Incorrect version of Instructions for Use were shipped to two US customers..
- Recalling firm
- RenovoRx, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-25
- Terminated
- 2016-02-29
- Firm location
- Los Altos, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
Incorrect version of Instructions for Use were shipped to two US customers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.