Events

Recall of Thermophore Classic Moist Heat pads

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Battle Creek Equipment Co..

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
    73286
  • Event Risk Class
    Class 2
  • Event Number
    Z-0349-2017
  • Event Initiated Date
    2016-09-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143763
  • 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
    Pad, heating, powered - Product Code IRT
  • Reason
    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

Thermophore Classic Moist Heat pads
  • Model / Serial
    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
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed within the United States, Canada, Mexico, Puerto Rico and Columbia
  • Product Description
    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
    Battle Creek Equipment Co.

Manufacturer

Battle Creek Equipment Co.
  • Manufacturer Address
    Battle Creek Equipment Co., 702 S Reed Rd, Fremont IN 46737-2098
  • Manufacturer Parent Company (2017)
    Battle Creek Equipment Co.
  • Source
    USFDA