Cincinnati Sub-Zero Products Inc: Medical Device Recall in 2016 - (Recall #: Z-0654-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

The Hemotherm 400CE 115v, containing power board p/n 39945

Product Classification:

Class II

Date Initiated: November 7, 2016

Date Posted: November 30, 2016

Recall Number: Z-0654-2017

Event ID: 75641

Reason for Recall:

The device may not maintain water flow or temperature control.

Status: Terminated

Product Quantity: 50

Code Information:

154-10360CE 163-10502CE 163-10512CE 163-10527CE 164-10537CE 163-10491CE 163-10503CE 163-10513CE 163-10528CE 164-10538CE 163-10493CE 163-10504CE 163-10514CE 163-10529CE 164-10539CE 163-10495CE 163-10505CE 163-10515CE 163-10530CE 164-10540CE 163-10496CE 163-10506CE 163-10521CE 164-10531CE 164-10543CE 163-10497CE 163-10507CE 163-10522CE 164-10532CE 164-10544CE 163-10498CE 163-10508CE 163-10523CE 164-10533CE 164-10545CE 163-10499CE 163-10509CE 163-10524CE 164-10534CE 164-10547CE 163-10500CE 163-10510CE 163-10525CE 164-10535CE 164-10548CE 163-10501CE 163-10511CE 163-10526CE 164-10536CE 164-10549CE

Distribution Pattern:

US Distribution to the states of : CA, FL, GA, MA, MN, NC, NJ, OH, PA and SC.

Voluntary or Mandated:

Voluntary: Firm initiated