Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypo
Summary
The FDA issued a Class II for Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (3 by Augustine Temperature Management, LLC. 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, .
Details
Source
Device Recall
External ID
Z-1197-2025
Action Date
2025-02-26
Status
Ongoing
Category
device
Product Description
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
Lot/Code Info: UDI-DI UDI-DI 00855913001817, Serial Numbers: 1304292, 1304293, 1304296, 1304297
Quantity Affected: 4 units
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.
Distribution
US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-16
Company
Minnetonka, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Augustine Temperature Management, LLC has 15 FDA actions in our database, including 13 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Augustine Temperature Management, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Augustine Temperature Management, LLC have FDA actions?
Augustine Temperature Management, LLC has 15 FDA actions in our database, including 13 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1197-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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