Rappel de Thermophore Classic Moist Heat pads

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Battle Creek Equipment Co..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    73286
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0349-2017
  • Date de mise en oeuvre de l'événement
    2016-09-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2018-01-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Pad, heating, powered - Product Code IRT
  • Cause
    Products manufactured with the spt cord have a known failure mode of sparking,causing smoke, fire and burns.
  • Action
    All consumers for which Battle Creek has contact information and that purchased a recalled pad will be contacted via first class mail. Consumers will be asked to contact us by phone after verifying that the model number and lot code is part of the recall. Battle Creek plans to add information about the recall on its web site including a pdf of the consumer letter. All customer consignees (non-consumer) will be informed of the recall. Email will be the most effective method , and mail and telephone calls will be used as needed.

Device

  • Modèle / numéro de série
    Model F00055-055 Standard Thermophore Lot codes:  0552712, 0552812, 0552912, 0553012, 0553112, 0553212, 0553312, 0553412, 0553512 , 0553612, 0553712, 0553812, 0553912, 0554012, 0554112, 0554212, 0554312, 0554412, 0554512, 0554612, 0554712, 0554812, 0554912, 0555012, 0555112, 0555212, 0550112, 0550213, 0550313, 0550413, 0550513, 0550613, 0550713, 0550813, 0550913, 0551013, 0551113, 0551213, 0551313, 0551413, 0551513, 0551613, 0551713, 0551813, 0551913, 0552013, 0552113, 0552213, 0552313, 0552413, 0552513, 0552613, 0552713, 0552813, 0552913, 0553013, 0553113, 0553213, 0553313, 0553413, 0553513, 0553613, 0553713, 0553813, 0553913, 0554013, 0554113, 0554213, 0554313, 0554413, 0554513, 0554613, 0554713, 0554813, 0554913, 055013, 0555113, 0555213, 0550113, 0550214, 0550314, 0550414, 0550514, 0550614, 0550714, 0550814, 0550914, 0551014, 0551114   Model F00255-255 Standard Thermophore Plus Lot codes: 2552712, 2552812, 2552912, 2553012, 2553112, 2553212, 2553312, 2553412, 2553512, 2553612, 2553712, 2553812, 2553912, 2554012, 2554112, 2554212, 2554312, 2554412, 2554512, 2554612, 2554712, 2554812, 2554912, 2555012, 2555112, 2555212, 2550112, 2550213, 2550313, 2550413, 2550513, 2550613, 2550713, 2550813, 2550913, 2551013, 2551113, 2551213, 2551313, 2551413, 2551513, 2551613, 2551713, 2551813, 2551913, 2552013, 2552113, 2552213, 2552313, 2552413, 2552513, 2552613, 2552713, 2552813, 2552913, 2553013, 2553113, 2553213, 2553313, 2553413, 2553513, 2553613, 2553713, 2553813, 2553913, 2554013, 2554113, 2554213, 2554313, 2554413, 2554513, 2554613, 2554713, 2554813, 2554913, 2555013, 2555113, 2555213, 2550113, 2550214, 2550314, 2550414, 2550514, 2550614, 2550714, 2550814, 2550914, 2551014, 2551114  Model F80095-095 Standard CSA Thermophore Lot code: 0952712, 0952812, 0952912, 0953012, 0953112, 0953212, 0953312, 0953412, 0953512, 0953612, 0953712, 0953812, 0953912, 0954012, 0954112, 0954212, 0954312, 0954412, 0954512, 0954612, 0954712, 0954812, 0954912, 0955012, 0955112, 0955212, 0950112, 0950213, 0950313, 0950413, 0950513, 0950613, 0950713, 0950813, 0950913, 0951013, 0951113, 0951213, 0951313, 0951413, 0951513, 0951613, 0951713, 0951813, 0951913, 0952013, 0952113, 0952213, 0952313, 0952413, 0952513, 0952613, 0952713, 0952813, 0952913, 0953013, 0953113, 0953213, 0953313, 0953413, 0953513, 0953613, 0953713, 0953813, 0953913, 0954013, 0954113, 0954213, 0954313, 0954413, 0954513, 0954613, 0954713, 0954813, 0954913, 0955013, 0955113, 0955213, 0950113, 0950214, 0950314, 0950414, 0950514, 0950614, 0950714, 0950814, 0950914, 0951014, 0951114    Model F00077-077 Petite Thermophore Lot codes:  0772712, 0772812, 0772912, 0773012, 0773112, 0773212, 0773312, 0773412, 0773512, 0773612, 0773712, 0773812, 0773912, 0774012, 0774112, 0774212, 0774312, 0774412, 0774512, 0774612, 0774712, 0774812, 0774912, 0775012, 0775112, 0775212, 0770112, 0770213, 0770313, 0770413, 0770513, 0770613, 0770713, 0770813, 0770913, 0771013, 0771113, 0771213, 0771313, 0771413, 0771513, 0771613, 0771713, 0771813, 0771913, 0772013, 0772113, 0772213, 0772313, 0772413, 0772513, 0772613, 0772713, 0772813, 0772913, 0773013, 0773113, 0773213, 0773313, 0773413, 0773513, 0773613, 0773713, 0773813, 0773913, 0774013, 0774113, 0774213, 0774313, 0774413, 0774513, 0774613, 0774713, 0774813, 0774913, 0775013, 0775113, 0775213, 0770113, 0770214, 0770314, 0770414, 0770514, 0770614, 0770714, 0770814, 0770914, 0771014, 0771114, 0771214, 0771314, 0771414, 0771514, 0771614, 0771714, 0771814, 0771914, 0772014, 0772114, 0772214, 0772314, 0772414, 0772514, 0772614, 0772714  Model F00277-277 Petite Thermophore Plus lot codes: 2772712, 2772812, 2772912, 2773012, 2773112, 2773212, 2773312, 2773412, 2773512, 2773612, 2773712, 2773812, 2773912, 2774012, 2774112, 2774212, 2774312, 2774412, 2774512, 2774612, 2774712, 2774812, 2774912, 2775012, 2775112, 2775212, 2770112, 2770213, 2770313, 2770413, 2770513, 2770613, 2770713, 2770813, 2770913, 2771013, 2771113, 2771213, 2771313, 2771413, 2771513, 2771613, 2771713, 2771813, 2771913, 2772013, 2772113, 2772213, 2772313, 2772413, 2772513, 2772613, 2772713, 2772813, 2772913, 2773013, 2773113, 2773213, 2773313, 2773413, 2773513, 2773613, 2773713, 2773813, 2773913, 2774013, 2774113, 2774213, 2774313, 2774413, 2774513, 2774613, 2774713, 2774813, 2774913, 2775013, 2775113, 2775213, 2770113, 2770214, 2770314, 2770414, 2770514, 2770614, 2770714, 2770814, 2770914, 2771014, 2771114, 2771214, 2771314, 2771414, 2771514, 2771614, 2771714, 2771814, 2771914, 2772014, 2772114, 2772214, 2772314, 2772414, 2772514, 2772614, 2772714   Model F80097-097 Petite CSA Thermophore Lot codes: 0972712, 0972812, 0972912, 0973012, 0973112, 0973212, 0973312, 0973412, 0973512, 0973612, 0973712, 0973812, 0973912, 0974012, 0974112, 0974212, 0974312, 0974412, 0974512, 0974612, 0974712, 0974812, 0974912, 0975012, 0975112, 0975212, 0970112, 0970213, 0970313, 0970413, 0970513, 0970613, 0970713, 0970813, 0970913, 0971013, 0971113, 0971213, 0971313, 0971413, 0971513, 0971613, 0971713, 0971813, 0971913, 0972013, 0972113, 0972213, 0972313, 0972413, 0972513, 0972613, 0972713, 0972813, 0972913, 0973013, 0973113, 0973213, 0973313, 0973413, 0973513, 0973613, 0973713, 0973813, 0973913, 0974013, 0974113, 0974213, 0974313, 0974413, 0974513, 0974613, 0974713, 0974813, 0974913, 0975013, 0975113, 0975213, 0970113, 0970214, 0970314, 0970414, 0970514, 0970614, 0970714, 0970814, 0970914, 0971014, 0971114, 0971214, 0971314, 0971414, 0971514, 0971614, 0971714, 0971814, 0971914, 0972014, 0972114, 0972214, 0972314, 0972414, 0972514, 0972614, 0972714   Model F00056-056 Medium Thermophore Lot codes: 0562712, 0562812, 0562912, 0563012, 0563112, 0563212, 0563312, 0563412, 0563512, 0563612, 0563712, 0563812, 0563912, 0564012, 0564112, 0564212, 0564312, 0564412, 0564512, 0564612, 0564712, 0564812, 0564912, 0565012, 0565112, 0565212, 0560112, 0560213, 0560313, 0560413, 0560513, 0560613, 0560713, 0560813, 0560913, 0561013, 0561113, 0561213, 0561313, 0561413, 0561513, 0561613, 0561713, 0561813, 0561913, 0562013, 0562113, 0562213, 0562313, 0562413, 0562513, 0562613, 0562713, 0562813, 0562913, 0563013, 0563113, 0563213, 0563313, 0563413, 0563513, 0563613, 0563713, 0563813, 0563913, 0564013, 0564113, 0564213, 0564313, 0564413, 0564513, 0564613, 0564713, 0564813, 0564913, 0565013, 0565113, 0565213, 0560113, 0560214, 0560314, 0560414, 0560514, 0560614, 0560714, 0560814, 0560914, 0561014, 0561114, 0561214, 0561314, 0561414, 0561514, 0561614, 0561714, 0561814, 0561914,0562014, 0562114, 0562214, 0562314, 0562414, 0562514, 0562614, 0562714, 0562814, 0562914  Model-F00256-256 Medium thermophore Plus lot codes:  2562712, 2562812, 2562912, 2563012, 2563112, 2563212, 2563312, 2563412, 2563512, 2563612, 2563712, 2563812, 2563912, 2564012, 2564112, 2564212, 2564312, 2564412, 2564512, 2564612, 2564712, 2564812, 2564912, 2565012, 2565112, 2565212, 2560112, 2560213, 2560313, 2560413, 2560513, 2560613, 2560713, 2560813, 2560913, 2561013, 2561113, 2561213, 2561313, 2561413, 2561513, 2561613, 2561713, 2561813, 2561913, 2562013, 2562113, 2562213, 2562313, 2562413, 2562513, 2562613, 2562713, 2562813, 2562913, 2563013, 2563113, 2563213, 2563313, 2563413, 2563513, 2563613, 2563713, 2563813, 2563913, 2564013, 2564113, 2564213, 2564313, 2564413, 2564513, 2564613, 2564713, 2564813, 2564913, 2565013, 2565113, 2565213, 2560113, 2560214, 2560314, 2560414, 2560514, 2560614, 2560714, 2560814, 2560914, 2561014, 2561114, 2561214, 2561314, 2561414, 2561514, 2561614, 2561714, 2561814, 2561914, 2562014, 2562114, 2562214, 2562314, 2562414, 2562514, 2562614, 2562714, 2562814, 2562914  Model F80096-096 Medium CSA Thermophore Lot codes:  0962712, 0962812, 0962912, 0963012, 0963112, 0963212, 0963312, 0963412, 0963512, 0963612, 0963712, 0963812, 0963912, 0964012, 0964112, 0964212, 0964312, 0964412, 0964512, 0964612, 0964712, 0964812, 0964912, 0965012, 0965112, 0965212, 0960112, 0960213, 0960313, 0960413, 0960513, 0960613, 0960713, 0960813, 0960913, 0961013, 0961113, 0961213, 0961313, 0961413, 0961513, 0961613, 0961713, 0961813, 0961913, 0962013, 0962113, 0962213, 0962313, 0962413, 0962513, 0962613, 0962713, 0962813, 0962913, 0963013, 0963113, 0963213, 0963313, 0963413, 0963513, 0963613, 0963713, 0963813, 0963913, 0964013, 0964113, 0964213, 0964313, 0964413, 0964513, 0964613, 0964713, 0964813, 0964913, 0965013, 0965113, 0965213, 0960113, 0960214, 0960314, 0960414, 0960514, 0960614, 0960714, 0960814, 0960914, 0961014, 096111, 40961214, 0961314, 0961414, 0961514, 0961614, 0961714, 0961814, 0961914, 0962014, 0962114, 0962214, 0962314, 0962414, 0962514, 0962614, 0962714, 0962814, 0962914
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed within the United States, Canada, Mexico, Puerto Rico and Columbia
  • Description du dispositif
    Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", || Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", || Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 || Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" || Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", || Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", || Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 || Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" || Used for the temporary relief of joint and muscle pain.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Battle Creek Equipment Co., 702 S Reed Rd, Fremont IN 46737-2098
  • Société-mère du fabricant (2017)
  • Source
    USFDA