Cincinnati Sub-Zero Products LLC: Medical Device Recall in 2018 - (Recall #: Z-0629-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 27, 2017

Date Posted: February 21, 2018

Recall Number: Z-0629-2018

Event ID: 78173

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.

Status: Terminated

Product Quantity: 1355 units

Code Information:

none

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated