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

Recall Z-2192-2018 — Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882

U.S. FDA — Device Enforcement · United States · 2018-05-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2192-2018
Date of alert
2018-05-10
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: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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