Recall Z-1171-2025— Augustine Temperature Management, LLC
Class II · Ongoing
Class II FDA medical device recall by Augustine Temperature Management, LLC, initiated 2024-02-15. It names 2 FDA 510(k) clearances: K230866, K210727. Product: Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.. Reason: Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact ..
- Recalling firm
- Augustine Temperature Management, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-15
- Firm location
- Minnetonka, MN, United States
510(k) clearances named in this recall
2 on FDA's record- K230866 — HotDog Warming Mattress + Return Electrode
- K210727 — HotDog Warming Mattress + Return Electrode
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.
Reason for recall
Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
Data sourced from openFDA. This site is unofficial and independent of the FDA.