Recall Z-1172-2025
Augustine Temperature Management, LLC · initiated February 15, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
Codes / lots: UDI-DI 00850011479674, Lot Number 2339
Reason for recall
Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
FDA-determined cause: Device Design
Action taken
Augustine Temperature Management contacted their consignees by visit beginning on 02/15/2024 to replace the affected cables. The firm collected email confirmation that the original cables had either been returned or destroyed. If you have any questions, contact the Product Manager at 952-465-3526 or email:
Details
- Recall number
- Z-1172-2025
- Initiated
- February 15, 2024
- Posted by FDA
- February 14, 2025
- Product code
- DWJ – System, Thermal Regulating
- Quantity
- 7 unit
- Distribution
- US distribution to states of: AL, TX, NV
- Recalling firm
- Augustine Temperature Management, LLC, Minnetonka, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1171-2025 Class II | Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136…Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact . | 02/15/2024Open, Classified |