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Recall Observatory FDA recall evidence

Device product

Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.

Z-1171-2025

February 15, 2024

Class II

Product summary

Firm
Augustine Temperature Management, LLC
Event
Event 95914
Status
Ongoing
Classification
Class II
Quantity
20 units
Official record key
device-enforcement:Z-1171-2025

Official wording

Reason: Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .

Code information: UDI-DI 00855913001794, Lot Number 2122

Distribution pattern: US distribution to states of: AL, TX, NV

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .