FDAFDA · Alimentos y medicamentos·N.º oficial Z-1825-2017
Hemotherm CE, model 400CE, Heater-Cooling Device
Publicado el 26 de abril de 2017 · Inicio del retiro: 9 de marzo de 2017
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Improperly rated fuses were used in the manufacture of the device.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Cincinnati Sub-Zero Products Inc
- Distribuidor
- 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.
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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