{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "171774", "product_res_number": "Z-1139-2019", "event_date_initiated": "2018-04-20", "event_date_created": "2019-04-12", "recall_status": "Completed", "res_event_number": "82531", "product_code": "DWJ", "k_numbers": [ "K113705" ], "product_description": "A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001\n\n indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol", "code_info": "Lot Number 27473 Quantity in lots 12 Part Number PIN-BH85, Lot Number 27590 Quantity in lots 6 Part Number PIN-SKY67-OS, Lot Number 27544 Quantity in lots 2 Part Number PIN-LG78-OS, Lot Number 27634 Quantity in lots 3 Part Number PIN-SUMMIT, and Lot Number 27498 Quantity in lots 1 Part Number PIN-PEDS", "firm_fei_number": "3009976772", "recalling_firm": "Pintler Medical LLC", "address_1": "701 W Broadway St", "city": "Philipsburg", "state": "MT", "postal_code": "59858", "additional_info_contact": "Maribeth Ellis\n406-859-0441", "reason_for_recall": "Malfunction warming pad.", "root_cause_description": "Nonconforming Material/Component", "action": "RECALL was isolated to the warming pads at this facility 100% of the pads were returned. Pintler Medical complaint logs- which includes reports from Field Reps, rework, customer feedback- calls/emails on site visits, show no previous occurrence of a like or similar event.\n\nPintler Medical principal has been in regular communication, phone, email and 2 facility visits with the reporting facilities identified point QA team. We have kept them informed to action taken, results of root cause analysis. All 24 warming pads are being replaced.\n\nIf you have any questions, contact Quality Assurance Principal at 406-859-0441 or email: Maribeth@pintlermedical.com.", "product_quantity": "24", "distribution_pattern": "US Distribution to state of: Wisconsin.", "openfda": { "k_number": [ "K902650", "K942599", "K181671", "K232502", "K913016", "K900186", "K881322", "K262089", "K001149", "K923104", "K071341", "K112488", "K950416", "K904690", "K952086", "K142702", "K913734", "K761087", "K242964", "K243942", "K232508", "K083662", "K102856", "K201779", "K140635", "K964377", "K261437", "K020604", "K942881", "K033021", "K031728", "K231211", "K123083", "K101148", "K002577", "K041686", "K981093", "K053645", "K952864", "K181699", "K920265", "K921920", "K200446", "K801253", "K113705", "K946196", "K083135", "K051336", "K180834", "K202197", "K131361", "K171373", "K023934", "K811742", "K092807", "K101589", "K992386", "K772015", "K180375", "K040632", "K040440", "K894980", "K051419", "K960511", "K231596", "K991684", "K232844", "K003349", "K161602", "K220941", "K022903", "K100585", "K914382", "K062794", "K072513", "K121669", "K140078", "K221669", "K093694", "K964673", "K083336", "K132454", "K963731", "K061902", "K141686", "K912051", "K210603", "K070112", "K920432", "K010338", "K890575", "K014121", "K080763", "K014210", "K071918", "K040911", "K200225", "K973705", "K171149", "K942790", "K232627", "K873745", "K820814", "K101092", "K203085", "K024128", "K812955", "K171234", "K251974", "K770839", "K152266", "K921165", "K011907", "K121720", "K190221", "K120849", "K960167", "K914805", "K052392", "K800812", "K093244", "K162679", "K061513", "K051278", "K120081", "K003368", "K110104", "K260903", "K162562", "K854856", "K102112", "K230866", "K940171", "K910327", "K882442", "K123946", "K260278", "K060865", "K132048", "K101705", "K001546", "K903360", "K873546", "K094056", "K073712", "K933764", "K210605", "K902756", "K771537", "K011859", "K232638", "K021473", "K811743", "K930345", "K051097", "K952329", "K970367", "K882035", "K914383", "K943276", "K252861" ], "registration_number": [ "2936999", "3005238200", "3013557562", "9680284", "1060680", "9614306", "3012494290", "8022590", "3005857264", "9610849", "3006240053", "3012972101", "3010476117", "1043572", "3021073836", "3036108847", "3012421607", "3014421917", "3010380518", "3004362278", "1836518", "1018233", "3005941719", "2133641", "3008879776", "3009746061", "1043214", "9617473", "3008727520", "2133810", "3007616088", "1725056", "2183744", "3007309299", "1055236", "3038241934", "2025816", "1722070", "1000484830", "9611590", "2032112", "9617604", "3003542872", "2432320", "1220351", "1054241", "3009609358", "3011059079", "1055823", "3044156918", "3012689738", "3013319212", "3010317211", "3034393266", "3013410562", "3010168054", "3009093866", "2183613", "1043644", "3010617000", "3030597679", "3031841433", "9616096", "2029015", "2530138", "3029871637", "3041276890", "3035108304", "3013041594", "3016844398", "3008352384", "3016507522", "3014426939", "1219702", "1417592", "9616567", "3018094310", "3013188547", "3012315097", "3043226252", "2320762", "1000122786", "3005997949", "3003857828", "3014263632", "3032911850", "1066427", "1516825", "3004491421", "3042272797", "2011171" ], "fei_number": [ "3003793491", "2936999", "3005238200", "3013557562", "1000208624", "1000112877", "3012494290", "3002963732", "3005857264", "3006240053", "3012972101", "3010476117", "1043572", "3021073836", "3007513035", "3036108847", "3002558692", "3012421607", "3014421917", "3010380518", "3004362278", "1018233", "3002807111", "3000203066", "3003329224", "3008879776", "3003040625", "3009746061", "1043214", "1000221205", "1000117260", "3008727520", "3003753496", "3007616088", "2183744", "3007309299", "3038241934", "2025816", "3495", "1000111140", "1000484830", "3003261020", "3003542872", "1220351", "3009609358", "3011059079", "3044156918", "3012689738", "3013319212", "1000237915", "3010317211", "3034393266", "3013410562", "3010168054", "3009093866", "2183613", "3002809016", "1043644", "3030597679", "3031841433", "1000160458", "3029871637", "3041276890", "3035108304", "3013041594", "3016844398", "3008352384", "3016507522", "1000112968", "3014426939", "1219702", "1417592", "3001733054", "3018094310", "3013188547", "3012315097", "3043226252", "1000122786", "3005997949", "3000203466", "3003857828", "3014263632", "3032911850", "3002807391", "1516825", "3004491421", "3042272797", "3003076831", "1000521377", "3003807323", "2011171" ], "device_name": "System, Thermal Regulating", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5900", "device_class": "2" } } ] }