Augustine HotDog Return Electrode connector cables trigger contact error
Augustine Surgical Inc. is recalling HotDog Return Electrode connector cables (Model A138) that display a 'Check Neutral Electrode Contact' error message. The recall affects 7 units distributed to Alabama, Texas, and Nevada.
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 classification with no reported illnesses, injuries, or deaths. The hazard—electrode contact failure—is theoretical, evidenced only by the error message appearing with no documented patient harm. Per the rubric, unconfirmed hazards without reported injury cap the score at 3 (High).
Plain-English summary
Augustine Temperature Management, LLC is recalling Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138, used with Warming Blankets and Mattresses. The recall involves 7 units distributed to healthcare facilities in Alabama, Texas, and Nevada (Lot Number 2339, UDI-DI 00850011479674).
Users have reported receiving an error message (M-0B-125) that states 'Check Neutral Electrode Contact.' This error indicates a potential issue with the electrode connector's contact function. While the error message serves as a warning system, the underlying contact failure could affect safe operation of the warming equipment.
The FDA classified this as a Class II recall. Affected users should discontinue use of affected connector cables and contact Augustine Temperature Management, LLC for replacement or repair instructions. Healthcare facilities should verify their equipment inventory to confirm whether Lot Number 2339 is present.
The recalled product
- Product
- Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
- Manufacturer
- Augustine Temperature Management, LLC
- Hazard
- electrode-contact
- electrical-safety
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 00850011479674
- Lot Number 2339
Distribution
Distributed in 3 states:
- AL
- NV
- TX
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