Events

Recall of Device Recall Hemotherm CE, model 400CE, HeaterCooling 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
    76718
  • Event Risk Class
    Class 2
  • Event Number
    Z-1825-2017
  • Event Initiated Date
    2017-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154013
  • 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
    Controller, temperature, cardiopulmonary bypass - Product Code DWC
  • Reason
    Improperly rated fuses were used in the manufacture of the device.
  • Action
    Letters were sent to customers and distributors instructing them to immediately cease use and/or further distribution of affected product, remove and discard the affected fuses and replace with the new fuses provided by CSZ, and complete and return the Field Action Response Form.

Device

Device Recall Hemotherm CE, model 400CE, HeaterCooling Device
  • Model / Serial
    151-10283CE, 151-10284CE, 151-10285CE, 151-10286CE, 151-10287CE, 151-10290CE, 151-10291CE, 151-10292CE, 151-10293CE, 151-10294CE, 151-10295CE, 151-10296CE, 151-10297CE, 151-10298CE, 151-10299CE, 152-10300CE, 152-10301CE, 152-10302CE, 152-10303CE, 152-10304CE, 152-10310CE, 152-10311CE, 152-10312CE, 152-10313CE, 152-10314CE, 153-10321CE, 153-10322CE, 153-10323CE, 153-10324CE, 154-10335CE, 154-10336CE, 154-10337CE, 154-10338CE, 154-10339CE, 154-10340CE, 154-10341CE, 154-10342CE, 154-10343CE, 154-10344CE, 154-10345CE, 154-10346CE, 154-10347CE, 154-10348CE, 154-10349CE, 154-10350CE, 154-10351CE, 154-10352CE, 154-10353CE, 154-10354CE, 154-10355CE, 154-10356CE, 154-10357CE, 154-10358CE, 154-10359CE, 154-10360CE, 154-10361CE, 154-10362CE, 154-10363CE, 154-10364CE, 154-10365CE, 154-10366CE, 154-10367CE, 154-10368CE, 154-10369CE, 154-10370CE, 154-10371CE, 154-10373CE, 154-10374CE, 154-10375CE, 161-10376CE, 161-10377CE, 161-10378CE, 161-10379CE, 161-10380CE, 161-10381CE, 161-10382CE, 161-10383CE, 161-10384CE, 161-10385CE, 161-10386CE, 161-10387CE, 161-10388CE, 161-10389CE, 161-10390CE, 161-10391CE, 161-10392CE, 161-10393CE, 161-10394CE, 161-10395CE, 161-10397CE, 161-10398CE, 161-10399CE, 161-10400CE, 161-10401CE, 161-10402CE, 161-10403CE, 161-10404CE, 161-10405CE, 161-10406CE, 161-10407CE, 161-10408CE, 161-10409CE, 161-10410CE, 161-10411CE, 161-10412CE, 161-10413CE, 161-10414CE, 161-10415CE, 161-10416CE, 161-10417CE, 161-10418CE, 161-10419CE, 161-10420CE, 162-10426CE, 162-10427CE, 162-10428CE, 162-10429CE, 162-10430CE, 162-10431CE, 162-10432CE, 162-10433CE, 162-10434CE, 162-10435CE, 162-10436CE, 162-10437CE, 162-10438CE, 162-10439CE, 162-10440CE, 162-10441CE, 162-10442CE, 162-10443CE, 162-10444CE, 162-10445CE, 163-10446CE, 163-10447CE, 163-10448CE, 163-10449CE, 163-10450CE, 163-10456CE, 163-10457CE, 163-10458CE, 163-10460CE, 163-10461CE, 163-10462CE, 163-10463CE, 163-10464CE, 163-10465CE, 163-10466CE, 163-10467CE, 163-10468CE, 163-10469CE, 163-10470CE, 163-10471CE, 163-10472CE, 163-10473CE, 163-10474CE, 163-10475CE, 163-10476CE, 163-10477CE, 163-10478CE, 163-10479CE, 163-10480CE, 163-10481CE, 163-10482CE, 163-10483CE, 163-10484CE, 163-10485CE, 163-10486CE, 163-10487CE, 163-10488CE, 163-10489CE, 163-10490CE, 163-10491CE, 163-10492CE, 163-10493CE, 163-10494CE, 163-10496CE, 163-10497CE, 163-10498CE, 163-10499CE, 163-10500CE, 163-10501CE, 163-10502CE, 163-10503CE, 163-10504CE, 163-10505CE, 163-10506CE, 163-10507CE, 163-10508CE, 163-10509CE, 163-10510CE, 163-10511CE, 163-10512CE, 163-10513CE, 163-10514CE, 163-10515CE, 163-10521CE, 163-10522CE, 163-10523CE, 163-10524CE, 163-10525CE, 163-10526CE, 163-10527CE, 163-10528CE, 163-10529CE, 163-10530CE, 163-10585CE, 164-10531CE, 164-10532CE, 164-10533CE, 164-10534CE, 164-10535CE, 164-10536CE, 164-10537CE, 164-10538CE, 164-10539CE, 164-10540CE, 164-10541CE, 164-10542CE, 164-10543CE, 164-10544CE, 164-10545CE, 164-10546CE, 164-10547CE, 164-10548CE, 164-10549CE, 164-10550CE, 164-10552CE, 164-10553CE, 164-10554CE, 164-10555CE, 164-10556CE, 164-10557CE, 164-10558CE, 164-10559CE, 164-10560CE, 164-10561CE, 164-10562CE, 164-10563CE, 164-10564CE, 164-10565CE, 164-10566CE, 164-10567CE, 164-10568CE, 164-10569CE, 164-10570CE, 164-10571CE, 164-10572CE, 164-10573CE, 164-10574CE, 164-10575CE, 164-10576CE, 164-10577CE, 164-10578CE, 164-10579CE, 164-10580CE, 164-10581CE, 164-10582CE, 164-10583CE, 164-10584CE, 164-10587CE, 164-10588CE, 164-10589CE, 164-10590CE, 164-10591CE, 164-10592CE, 164-10593CE, 164-10594CE, 164-10595CE, 164-10596CE, 164-10597CE, 164-10598CE, 164-10599CE, 164-10600CE, 164-10601CE, 164-10602CE, 164-10603CE, 164-10604CE, 164-10605CE, 164-10606CE, 164-10607CE, 164-10608CE, 164-10609CE, 164-10610CE, 164-10613CE, 164-10614CE, 164-10615CE, 164-10616CE, 164-10617CE, 164-10618CE, 164-10619CE, 164-10620CE, 164-10621CE, 164-10622CE, 164-10623CE, 164-10624CE, 164-10625CE, 164-10626CE, 164-10627CE, 164-10629CE, 164-10630CE, 164-10631CE, 164-10632CE, 164-10633CE, 164-10634CE, 164-10635CE, 164-10636CE, 164-10637CE, 164-10638CE, 164-10639CE, 164-10640CE, 164-10641CE, 164-10642CE, 164-10643CE, 164-10644CE, 164-10645CE, 164-10646CE, 164-10647CE, 164-10648CE, 164-10649CE, 164-10650CE, 164-10651CE, 164-10652CE, 164-10653CE, 164-10654CE, 164-10655CE, 164-10656CE, 164-10657CE, 164-10658CE, 164-10659CE, 164-10660CE, 164-10661CE, 164-10662CE, 164-10663CE, 164-10664CE, 164-10665CE, 164-10666CE, 164-10667CE, 164-10669CE, 164-10670CE, 164-10671CE, 171-10672CE, 171-10673CE, 171-10674CE, 171-10675CE, 171-10676CE, 171-10677CE, 171-10678CE, 171-10679CE, 171-10680CE, 171-10681CE, 171-10682CE, 171-10683CE, 171-10684CE, 171-10685CE, 171-10686CE, 171-10687CE, 171-10688CE, 171-10689CE, 171-10690CE, 171-10692CE, 171-10693CE, 171-10694CE, 171-10695CE, 171-10696CE, 171-10697CE, 171-10698CE, 171-10699CE, 171-10700CE, 171-10701CE, 171-10702CE, 171-10703CE, 171-10704CE, 171-10705CE, 171-10706CE, 171-10707CE, 171-10708CE, 171-10709CE, 171-10710CE, 171-10711CE, 171-10712CE, 171-10713CE, 171-10714CE, 171-10715CE, 171-10716CE, 171-10717CE, 171-10718CE, 171-10719CE, 171-10720CE, and 171-10721CE
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. The recalled product was distributed to the following states: AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, and WI. The recalled product was distributed to the following countries: Mexico, Taiwan. There are no Canada accounts for this recall. There is one (1) Mexico account for this recall: Koolfer S.A. DE C.V., San Isidro 168, Col. Pedregal De Santa Ursula Coapa, Del. Coyoacan, CP. Mexico D. F. 04600. There is one (1) government account for this recall: WRNMMC -PAA, 8965 Brown Dr, Bethesda, MD 20889.
  • Product Description
    Hemotherm CE, model 400CE, Heater-Cooling Device
  • 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