Augustine HotDog return electrode connector cables electrode contact error recall
Augustine Temperature Management is recalling HotDog return electrode accessory connector cables (Model A136) used with warming blankets and mattresses. Users reported error M-0B-125 indicating improper neutral electrode contact.
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 illnesses. The hazard—improper neutral electrode contact indicated by error message M-0B-125—represents a potential safety risk, but without documented harm, the severity is rated High per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Augustine Temperature Management, LLC is recalling Augustine Surgical Inc. HotDog Return Electrode accessory connector cables (Model A136, Lot Number 2122). These cables are used in conjunction with warming blankets and mattresses.
Users have reported receiving error message M-0B-125 with the instruction 'Check Neutral Electrode Contact.' This error indicates a potential malfunction related to electrode contact integrity.
The affected devices (20 units) were distributed to medical facilities in Alabama, Texas, and Nevada. The recalled cables are identified by UDI-DI 00855913001794.
If you have the recalled product, contact Augustine Temperature Management, LLC or your healthcare facility's clinical engineering or equipment management department for further instructions.
The recalled product
- Product
- Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.
- Manufacturer
- Augustine Temperature Management, LLC
- Hazard
- improper-electrode-contact
- electrical-safety-risk
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 00855913001794
- Lot Number 2122
Distribution
Distributed in 3 states:
- AL
- NV
- TX
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