Patient Warming Mattress Connector Cable Intermittent Connection Defect
Augustine Temperature Management is recalling Hot Dog Patient Warming Mattresses due to connector cable defects that may cause intermittent electrical connection after extended use, potentially affecting the device's heating function.
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 involving a connection defect with no reported injuries or illnesses. The defect meets the high-severity criterion as a risk-of-harm product where injury has not yet been reported—an intermittent electrical connection on a patient warming device could prevent proper function.
Plain-English summary
Augustine Temperature Management, LLC is recalling the Hot Dog PATIENT WARMING Underbody Warming Mattress (Model US502, 127 cm / 50 inches). The recall is due to a defect in the over-molding that stabilizes the connection between the cable and cable-entry point on the mattress. After approximately one year of use, this defect can cause the connector cable to experience deflection, resulting in intermittent electrical connection with the cables connected to the electrical safety unit (ESU).
The affected warming mattresses were distributed nationwide in Texas, Alabama, and Nevada, as well as in Australia and New Zealand. The recalled device is identified by Serial Number 1304283 (UDI-DI: 00855913001824, REF US502).
Users of the affected mattress should immediately discontinue use and contact Augustine Temperature Management for instructions regarding replacement or repair. An intermittent electrical connection could impair the device's ability to deliver proper warming function.
The recalled product
- Product
- Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
- Manufacturer
- Augustine Temperature Management, LLC
- Affected units
- 1
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 (2)
- UDI-DI UDI-DI 00855913001824
- Serial Numbers: 1304283
Distribution
Part of a larger recall action
This product is one of 3 recalled by Augustine Temperature Management, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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