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Recall Observatory FDA recall evidence

Device product

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

Z-0654-2017

November 07, 2016

Class II

Product summary

Firm
Cincinnati Sub-Zero Products Inc
Event
Event 75641
Status
Terminated
Classification
Class II
Quantity
50
Official record key
device-enforcement:Z-0654-2017

Official wording

Reason: The device may not maintain water flow or temperature control.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The device may not maintain water flow or temperature control.