Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
This recall has been completed (originally issued January 10, 2025).
- Recall Initiated
- March 14, 2022
- Posted
- January 10, 2025
- Recall Number
- Z-0839-2025
- Quantity
- 17 units
- Firm Location
- Minnetonka, MN
- Official Source
- View on FDA website ↗
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".
Distribution
Worldwide
Lot / Code Info
1) UDI-DI 00850011479018, Serial Numbers: 23060144, 22030085, 22030087, 22030088, 23060138, 23060139, 22030075, 22030076, 22030077, 22030079, 22030080, 22030081, 22030082, 22030083, 22030084, 23060141; 2) UDI-DI 00850011479285, Serial Numbers: 20080002
Root 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.