Reported Jan 6, 2016 · Terminated
RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular:…
RenovoRx, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RenovoRx, Inc. · 4546 El Camino Real Ste 282 · Los Altos, CA · 94022-1068
Is this the product you have?
- RenovoCath RC 120; Temporary Intravascular
- Occluding Catheter Model numberMMRC120-DB-1111; Rx only
- CardiovascularThe 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
- Lot codes and dates
- Model numberMMRC120-DB-1111
- Lot numberB2456974A; Expiry 2016-07. Lot B2457150A - all 72 units were either used or returned prior to initiation of recall
- Amount recalled
- 11 units
Where it was sold
Why it was recalled
Incorrect version of Instructions for Use were shipped to two US customers.
This product could cause temporary or reversible health problems — stop using it.
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