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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