Augustine Temperature Management, LLC recalls Augustine Surgical Inc. HotDog Return Electrode accessory connector cables
Reason for recall
Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and MattressesUDIUDI-DI 00850011479674Affected lot2339
What the firm is doing
Augustine Temperature Management contacted their consignees by visit beginning on 02/15/2024 to replace the affected cables. The firm collected email confirmation that the original cables had either been returned or destroyed. If you have any questions, contact the Product Manager at 952-465-3526 or email:
DistributionShow detailsHide
US distribution to states of: AL, TX, NV
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1172-2025
- FDA 510(k) clearance · K210727The device's official FDA premarket clearance record
- FDA 510(k) clearance · K230866The device's official FDA premarket clearance record
- FDA device classification · DWJOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.5900The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Augustine Temperature Management, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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