The Recall Desk
ModerateFDA (Devices)·Z-0700-2025·Announced 2024-12-25

HOT DOG Temperature Management Controller Instructions for Use Update

Augustine Temperature Management is updating instructions for HOT DOG Patient Warming Controllers (Models WC71, WC71R) regarding a power-on self-test error code. The update affects 135 units distributed in the US and Canada.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II medical device recall with no reported injuries or illnesses. The recall consists of an update to instructions for use regarding a power-on self-test error code, representing a precautionary measure with no documented patient harm.

Plain-English summary

Augustine Temperature Management, LLC is issuing an update to the instructions for use for its HOT DOG Patient Warming Temperature Management Controllers, Models WC71 and WC71R (refurbished). The update addresses a power-on self-test error code designated as 'EA POST' that may occur when the device is powered on.

These controllers are used in conjunction with warming blankets and mattresses to manage patient body temperature during medical procedures. The self-test error code indicates a potential operational issue with the device.

Approximately 135 units have been distributed throughout the US and Canada. Affected devices have Serial Numbers 20080004 through 23060141 and are identified by UDI-DI 00850011479018 (Model WC71) and UDI-DI 00850011479285 (Model WC71R).

Healthcare facilities and medical professionals using these devices should review the updated instructions for use and follow the guidance provided regarding the EA POST error code. Contact Augustine Temperature Management directly for additional information or support.

The recalled product

Product
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.
Manufacturer
Augustine Temperature Management, LLC
Category
Medical Device — Patient Warming Device
Hazard
  • self-test-error
  • device-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • 1) UDI-DI 00850011479018
  • Serial Numbers: 20080004-23060141
  • 2) UDI-DI 00850011479285

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category