Hot Dog Patient Warming Mattress Connector Cable Deflection Recall
Augustine Temperature Management is recalling 4 units of the Hot Dog Patient Warming Mattress due to connector cable deflection that causes intermittent connection failures after approximately one year of use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported injuries or deaths. The hazard involves intermittent loss of warming function in a critical-care hypothermia treatment device, presenting a risk of harm. Per the rubric, this qualifies as 'High': risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Hot Dog Patient Warming Mattress is a medical device designed to prevent or treat hypothermia. It consists of an underbody warming mattress with a return electrode, measuring 82 cm (32 inches).
Augustine Temperature Management, LLC is recalling 4 units of the Hot Dog Patient Warming Mattress (REF US501, UDI-DI 00855913001817) due to a cable connection defect. The connector cable on the mattress can experience deflection after approximately one year of use, causing intermittent connection failures with the electronic control unit.
The recalled units were distributed in the United States (Texas, Alabama, and Nevada) and internationally (Australia and New Zealand). The affected serial numbers are 1304292, 1304293, 1304296, and 1304297.
If you have a recalled unit and experience intermittent function or connection issues, discontinue use and contact Augustine Temperature Management, LLC for repair or replacement instructions.
The recalled product
- Product
- Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
- Manufacturer
- Augustine Temperature Management, LLC
- Hazard
- cable-connection-failure
- intermittent-function
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 (5)
- UDI-DI UDI-DI 00855913001817
- Serial Numbers: 1304292
- 1304293
- 1304296
- 1304297
Distribution
Distributed nationwide across the United States.
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