Recall Z-0842-2025
Augustine Temperature Management, LLC · initiated March 14, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
Codes / lots: 1) UDI/DI 00850011479247, Serial Numbers: 20090015, 20090016, 20090017, 20090018, 20090020, 20090021, 20090022, 20090023, 20090024, 20090025, 20090026, 20090027, 20090028, 20090029, 20090030, 20090031, 20090032, 20090033, 20090034, 20090035, 20090036, 20090037, 20090038, 20090039, 20090040, 20090041, 20090042, 20090043, 20090044, 20100030, 20100031, 20100032, 20100033, 20100034, 20100035, 20100036, 20100037, 20100038, 20100040, 20100041, 20100042, 20100043, 20100044, 20100045, 20100046, 20100047, 20100048, 20100049, 20100050, 20100051, 20100052, 20100053, 20100054, 20100055, 20100056, 20100057, 20100058, 20100059, 20100091, 20100092, 20100093, 20100094, 20100095, 20100096, 20100097, 20100098, 20100099, 20100100, 20100101, 20100103, 20110000, 20110001, 20110002, 20110003, 20110004, 20110005, 20110006, 20110006, 20110007, 20110008, 20110009, 20110010, 20110011, 20110012, 20110013, 20110014, 20110015, 20110016, 20110017, 20110018, 20110019, 20110020, 20110021, 20110022, 20110023, 20110024, 20110025, 20110026, 20110027, 20110028, 20110029, 20110030, 20110031, 20110032, 20110033, 20110034, 20110035, 20110036, 20110037, 20110038, 20110039, 20110040, 20110041, 20110042, 20110043…
Reason for recall
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
FDA-determined cause: Device Design
Action taken
Augustine Temperature Management, LLC began correcting (installing ferrites and software updates) the affected devices February, 2022 and completed the actions in August 2023. The firm did not perform any notification to its consignees that corrections would be implemented.
Details
- Recall number
- Z-0842-2025
- Initiated
- March 14, 2022
- Posted by FDA
- January 10, 2025
- Product code
- DWJ – System, Thermal Regulating
- Quantity
- 2271 units
- Distribution
- Worldwide
- Recalling firm
- Augustine Temperature Management, LLC, Minnetonka, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0839-2025 Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller…HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model… | 03/14/2022Completed |
| Z-0840-2025 Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller…HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model… | 03/14/2022Completed |
| Z-0841-2025 Class II | Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with…HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model… | 03/14/2022Completed |
| Z-0843-2025 Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller…HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model… | 03/14/2022Completed |