RecallRadar

FDA Device recall Z-0654-2017

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

On 2016-11-30 the FDA classified a Class II recall of The Hemotherm 400CE 115v, containing power board p/n 39945 by Cincinnati Sub Zero Products, citing the device may not maintain water flow or temperature control.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0654-2017
ClassificationClass II
Statusterminated
Initiated2016-11-07
Published2016-11-30
Last updated2026-09-13 11:54 UTC
CompanyCincinnati Sub Zero Products
DistributionCA, FL, GA, MA, MN, NC, NJ, OH, PA, SC

Product

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

Reason

The device may not maintain water flow or temperature control.

Identifiers

code_info
154-10360CE 163-10502CE 163-10512CE 163-10527CE 164-10537CE 163-10491CE 163-10503CE 163-10513CE 163…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0654-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.