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

Recall Z-1701-2016 — Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.

U.S. FDA — Device Enforcement · United States · 2016-03-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1701-2016
Date of alert
2016-03-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Angiodynamics Inc. (Navilyst Medical Inc.)
Product category
device
Product type
Devices
Reported risk: Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs.
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.

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