ClearanceBrief
Recall Z-0349-2017 ยท IRT Pad, Heating, Powered

Battle Creek Equipment Co.

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 Mo

DateSep 15, 2016
StatusTerminated
ReasonProducts manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns.
Root causeDevice Design
ActionAll 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.
Quantity99,060
DistributionDistributed within the United States, Canada, Mexico, Puerto Rico and Columbia
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.