{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "190737", "product_res_number": "Z-0496-2022", "event_date_initiated": "2021-11-22", "event_date_created": "2022-01-13", "recall_status": "Terminated", "event_date_terminated": "2023-05-08", "res_event_number": "89193", "product_code": "ILO", "product_description": "Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193", "code_info": "UDI- 10613031861938;\n\nAffected Serial Numbers are: (164-76703084 Through 213-76703694)", "firm_fei_number": "1516825", "recalling_firm": "Gentherm Medical, LLC", "address_1": "12011 Mosteller Rd Fl 3 12011 Mosteller Rd", "address_2": "Fl 3", "city": "Blue Ash", "state": "OH", "postal_code": "45241-1528", "reason_for_recall": "This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.", "root_cause_description": "Device Design", "action": "URGENT Medical Device Recall notification letters dated 11/19/21 were sent to customers.\n\nPad Instructions:\n1. Read and understand operation manual before connecting paCI to Etectri-Cool II.\n2. Read and understand pad application instructions accompanying GENTHERM pad.\n3. Connect hose to unit by inserting connectors on hose into connectors on unit. Connectors should \"click\" as they lock together.\n4. Apply pad to patient and attach pad to hose by inserting connectors on pad into hose connectors. Normal use of the pad is to be applied in direct contact with the patient. Pad may be used over or under a patient, in the flat state or wrapped around patient.\n5. Turn unit \"ON\" and set to temperature.\n6. After pad has filled, check water level in unit. Add sterile water or water that has been passed through a filter less than or equal to 0.22 microns, only if necessary.\n7. When therapy needs to be paused, disconnect the pad from the Electri-Cool II and allow the unit to continue to run. NOTE: Reconnect the pad when ready to resume therapy.\n8. When therapy is no longer needed disconnect pad from hose by pressing metal clips. Dispose of pad.\n9. Tum unit \"OFF\" at the power switch and unplug the power cord from the outlet.\n\nINSTRUCTIONS TO CUSTOMERS:\n1) Immediately examine your inventory and add this letter and/or Appendix B to Electri-Cool II manual.\n2) Ensure that all users are informed of the contents of this letter. If you have further distributed this product, please provide those accounts with a copy of this notice.\n3) Please complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to inform Gentherm Medical, LLC that you have performed and completed the requested actions. Return the form by e-mail to FA2021-012@gentherm.com, or mail to:\nGentherm Medical, LLC\n12011 Mosteller Road\nCincinnati, OH 45241\nThis recall should be carried out to the user level. Your assistance is appreciated and necessary to reduce potent", "product_quantity": "484 devices", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.", "openfda": { "k_number": [ "K954095", "K945468", "K843146", "K935841", "K926151", "K964354", "K915196", "K882310", "K801301", "K912722", "K943844", "K961855", "K931843", "K900356", "K891152", "K902268", "K760527", "K083008", "K914434", "K073675", "K945067", "K942882", "K964057", "K921540", "K930634", "K973023", "K945399", "K890853", "K791162", "K961425", "K913729", "K900355", "K890852", "K891603", "K945853", "K962537", "K852495", "K832820", "K943497", "K883681", "K760804", "K911943", "K962983", "K936143", "K940160", "K964006", "K213097", "K955529", "K884255", "K963596", "K950711", "K964799", "K832819", "K930918", "K970533", "K893706", "K072152", "K040317", "K761254", "K904998", "K920581", "K833564", "K891092", "K955326", "K830757", "K940858", "K760910", "K931203", "K913026", "K902269", "K891151", "K964710", "K955057", "K945467", "K961621", "K944971", "K910061", "K940429", "K871962", "K070402", "K970197", "K950395", "K871963", "K780452", "K953532", "K891091", "K760782", "K963261", "K914182", "K925677", "K923643", "K934262", "K944447" ], "registration_number": [ "3007774549", "", "3004116008", "1723702", "3015004731", "3033511104", "3015501220", "3030446844", "3016171827", "3007582661", "3035374295", "3030387297", "3017866840", "3009125070", "9613793", "3030478415", "3019849074", "3038295706", "3030151584", "3011529836", "2028253", "3007353136", "3004713344", "1531264", "3021380980", "3016746289", "3014542717", "3014264913", "3015619973", "3011270181", "3037609256", "3009155756", "1835315", "3007543825", "3006416350", "3013180212", "3008395114", "3011767724", "3043709874", "3003855981", "3045077467", "3011684767", "3004605321", "3008236846", "1516825", "3005730446", "3025430561", "1055823", "3016969935", "3010675856", "3009437400", "3012157621", "3008523132", "3025034781", "3042284335", "3027643666", "3008724689", "3027500264", "8043817", "1648700", "3042254805", "3008570882", "3009142693", "2029275", "3011539161", "2011068", "9616086", "3015252349", "3017150671", "3011853381", "3017264244", "3030648824", "3031646688", "3011191255", "3015489752", "3032062344", "1043214", "1528161", "3013069546", "1649518", "3010160370", "3016915446", "1834003", "3003542872", "3011689956", "3007649424", "3003764610", "3042277508", "1060680", "3027328721", "1417592", "3033648890", "1000548922", "3014834638", "3043140701", "9680425", "3010251529", "3003890514", "3017555752", "3018269548", "3011491271", "3018109879", "3007309299", "3010960892", "3007109661", "3015960622", "1927395", "9611559", "3015907115", "2424387", "3015727296", "3013002868", "3016159364", "9616309", "1058584", "1054241", "2320762", "3010694026", "3017965926", "3033845665", "2030732", "3003619590", "3014386328", "3023876581", "3017202421", "3021282523", "3026294985", "3012841710" ], "fei_number": [ "3007774549", "", "3004116008", "3015004731", "3033511104", "1000208624", "3015501220", "3030446844", "3016171827", "3007582661", "3035374295", "3030387297", "3017866840", "3009125070", "1000306431", "3030478415", "3019849074", "3038295706", "3030151584", "3011529836", "3007353136", "3004713344", "1000111140", "3021380980", "3016746289", "3014542717", "3014264913", "3015619973", "3011270181", "3037609256", "3009155756", "3007543825", "3000204953", "3006416350", "3013180212", "3008395114", "3011767724", "3043709874", "3003855981", "3045077467", "3011684767", "3000215572", "3004605321", "3008236846", "1516825", "3005730446", "3025430561", "3000204260", "3016969935", "3010675856", "1000112877", "3009437400", "3012157621", "3008523132", "1000139922", "1000219637", "3025034781", "3042284335", "3027643666", "3008724689", "3027500264", "3003255513", "3042254805", "3009142693", "3006076154", "3011539161", "2011068", "3015252349", "3017150671", "3011853381", "2937446", "3017264244", "3030648824", "3031646688", "3011191255", "3015489752", "3032062344", "1043214", "3013069546", "3010160370", "3016915446", "1000125378", "3003542872", "3011689956", "3007649424", "3003750857", "3003764610", "3042277508", "3027328721", "1417592", "3033648890", "1000548922", "3001236277", "3014834638", "3043140701", "3003890514", "3010251529", "3017555752", "3007596547", "3018269548", "3003094575", "3011491271", "3018109879", "3007309299", "3010960892", "3006469671", "3007109661", "3015960622", "1927395", "3015907115", "2424387", "1000122747", "3015727296", "3013002868", "3016159364", "3010694026", "3017965926", "3033845665", "3002865632", "3003619590", "3014386328", "3023876581", "3017202421", "3021282523", "3026294985", "3003040625", "3000210417", "3012841710" ], "device_name": "Pack, Hot Or Cold, Water Circulating", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.5720", "device_class": "2" } } ] }