FDA Enforcement
Class II
Ongoing
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
Recall: Z-1172-2025
·
Reported February 26, 2025
Enforcement
- Recall Number
- Z-1172-2025
- Event ID
- 95914
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Augustine Temperature Management, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- February 26, 2025
- Initiation Date
- February 15, 2024
- Classification Date
- February 14, 2025
- Address
- 15305 Minnetonka Blvd, N/A, Minnetonka, MN, 55345-1512, United States
Description
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
Reason
Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
Code Info
UDI-DI 00850011479674, Lot Number 2339
Distribution
US distribution to states of: AL, TX, NV
Quantity
7 unit