FDAFDA · Food and drugs·Recall number Z-0565-2016
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.
Published January 6, 2016 · Recall initiated: November 25, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect version of Instructions for Use were shipped to two US customers.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- RenovoRx, Inc.
- Distributor
- US Distribution to the states of : CA and FL.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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