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

Recall Z-1569-2013 — Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature

U.S. FDA — Device Enforcement · United States · 2013-05-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1569-2013
Date of alert
2013-05-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Terumo Cardiovascular Systems Corporation
Product category
device
Product type
Devices
Reported risk: Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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