Recall Z-0701-2025
Augustine Temperature Management, LLC · initiated December 4, 2024
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, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
Codes / lots: 1) UDI-DI 00850011479025, Serial Numbers: 20080060-24060065; 2) UDI/DI 00850011479292, Serial Numbers: 20080060-24060065; 3) UDI-DI 00850011479308, Serial Numbers: 20080060-24060065
Reason for recall
Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".
FDA-determined cause: Device Design
Action taken
Augustine Temperature Management issued a Field Notification to its consignees on 12/04/2024 via email. The notice explained the issue, potential risk, and advised that there is an update to the User and Technical Manual to further clarify existing instructions for the device. If the device was further distributed, those distributing the device were directed to notify those to whom the device was distributed. Consignees are expected to respond via email. An optional power board update is available. For questions or concerns, contact: customercare@augsurg.com or by telephone, 952-465-3500, fax, 952-465-3501, 8AM - 5PM Central time.
Details
- Recall number
- Z-0701-2025
- Initiated
- December 4, 2024
- Posted by FDA
- December 18, 2024
- Product code
- DWJ – System, Thermal Regulating
- Quantity
- 1776 units
- Distribution
- US and Canada
- Recalling firm
- Augustine Temperature Management, LLC, Minnetonka, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0700-2025 Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller…Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature… | 12/04/2024Open, Classified |
| Z-0702-2025 Class II | Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with…Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature… | 12/04/2024Open, Classified |