Patient Warming Mattress Recalled for Cable Connection Defect
Augustine Temperature Management recalls 3 Hot Dog patient warming mattresses (US530) due to cable connector deflection that may cause intermittent connection failure, potentially occurring after 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: FDA Class II medical device used for critical patient warming and hypothermia prevention. Cable deflection could cause device malfunction and loss of therapeutic function, creating potential risk of harm. No injuries have been reported to date.
Plain-English summary
Augustine Temperature Management is recalling 3 Hot Dog PATIENT WARMING Underbody Warming Mattresses (Model US530, 35 inches) due to a cable connection defect. The mattresses are used to prevent or treat hypothermia.
The recall concerns over-molding at the cable-entry point on the mattress. After approximately one year of use, the connector cable may experience deflection that causes intermittent loss of connection between the mattress and the external warming unit (ESU). This loss of connection could result in the mattress failing to provide warming.
The recalled units are identified by UDI-DI 00855913001848 and serial numbers 1304384, 1304619, and 1304620. Affected units were distributed nationwide in Texas, Alabama, and Nevada, as well as to Australia and New Zealand.
Consumers and healthcare facilities should verify their serial numbers against the recall. Affected device users should contact Augustine Temperature Management for instructions on replacement or repair.
The recalled product
- Product
- Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
- Manufacturer
- Augustine Temperature Management, LLC
- Category
- Medical Device — Patient Warming
- Hazard
- cable-malfunction
- device-failure
- intermittent-connection
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 (4)
- UDI-DI UDI-DI 00855913001848
- Serial Numbers: 1304384
- 1304619
- 1304620
Distribution
Distributed nationwide across the United States.
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