Recall Z-1197-2025— Augustine Temperature Management, LLC
Class II · Ongoing
Class II FDA medical device recall by Augustine Temperature Management, LLC, initiated 2024-12-16. It names one FDA 510(k) clearance: K230866. Product: Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia. Reason: There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU..
- Recalling firm
- Augustine Temperature Management, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-16
- Firm location
- Minnetonka, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
Reason for recall
There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
Data sourced from openFDA. This site is unofficial and independent of the FDA.