Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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 perip

U.S. FDA — Device Enforcement · United States · 2015-11-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0565-2016
Date of alert: 2015-11-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: RenovoRx, Inc.
Product category: device
Product type: Devices

Reported risk: Incorrect version of Instructions for Use were shipped to two US customers.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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