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FDAFDA · Food and drugs·Recall number Z-1825-2017

Hemotherm CE, model 400CE, Heater-Cooling Device

Published April 26, 2017 · Recall initiated: March 9, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Improperly rated fuses were used in the manufacture of the device.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Cincinnati Sub-Zero Products Inc
Distributor
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.
Lot
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, 164-10637
Risk classification
Class II
Area (FDA)
device
Country
United States

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