Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming
FDA device recall Z-1172-2025 · posted 2025-02-14 · Open, Classified
Recall details
- Recalling firm
- Augustine Temperature Management, LLC
- Reason for recall
- Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
- 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:
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- DWJ
- Quantity affected
- 7 unit
- Distribution
- US distribution to states of: AL, TX, NV
- Date initiated
- 2024-02-15
- Date posted
- 2025-02-14
- Location
- Minnetonka, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HotDog Warming Mattress + Return Electrode (K230866) | Augustine Temperature Management, LLC | 2023-06-29 |
| HotDog Warming Mattress + Return Electrode (K210727) | Augustine Temperature Management, LLC | 2022-02-01 |