Home / Recalls / Cincinnati Sub-Zero Products LLC / Z-0629-2018

Z-0629-2018 Class II Terminated

Recalled by Cincinnati Sub-Zero Products LLC — Cincinnati, OH

Recall Details

Product Type
Devices
Report Date
February 21, 2018
Initiation Date
November 27, 2017
Termination Date
July 2, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1355 units

Product Description

Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.

Reason for Recall

Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.

Distribution Pattern

US Nationwide Distribution

Code Information

none

Other recalls by Cincinnati Sub-Zero Products LLC

  • Z-1825-2017 Class II — Hemotherm CE, model 400CE, Heater-Cooling Device (March 9, 2017)
  • Z-0654-2017 Class II — The Hemotherm 400CE 115v, containing power board p/n 39945 (November 7, 2016)
  • Z-1129-2015 Class II — Cold Therapy Pad - cold water circulating pad, one unit per package. The pads (January 7, 2015)
  • Z-1679-2014 Class II — 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to (January 8, 2014)
  • Z-2209-2013 Class II — Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Most (September 3, 2013)
  • Z-0443-2014 Class II — Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Expo (May 15, 2013)