Events

Recall of Device Recall HeaterCooler Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cincinnati Sub-Zero Products Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75641
  • Event Risk Class
    Class 2
  • Event Number
    Z-0654-2017
  • Event Initiated Date
    2016-11-07
  • Event Date Posted
    2016-11-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150976
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Instruments, surgical, cardiovascular - Product Code DWS
  • Reason
    The device may not maintain water flow or temperature control.
  • Action
    Cincinnati Sub-Zero sent an Urgent Medical Device Correction letter date November 7, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm has notified all customers to discontinue use and contact CSZ. Upon receipt of the new board, immediately remove and discard the affected power board and replace it with the newly provided power board. The complete and return the customer response form. For further questions, please call (513) 772-8810

Device

Device Recall HeaterCooler Device
  • Model / Serial
    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
  • Product Classification
    Cardiovascular Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : CA, FL, GA, MA, MN, NC, NJ, OH, PA and SC.
  • Product Description
    The Hemotherm 400CE 115v, containing power board p/n 39945
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • Manufacturer Address
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • Manufacturer Parent Company (2017)
    Gentherm, Inc.
  • Source
    USFDA