Class 2 Device Recall Hot Dog PATIENT WARMING

• Date Initiated by Firm: December 16, 2024
• Date Posted: February 20, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1197-2025
• Recall Event ID: 96155
• 510(K)Number: K230866
• Product Classification: System, thermal regulating - Product Code DWJ
• Product: Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
• Code Information: UDI-DI UDI-DI 00855913001817, Serial Numbers: 1304292, 1304293, 1304296, 1304297
• Recalling Firm/ Manufacturer: Augustine Temperature Management, LLC; 15305 Minnetonka Blvd; Minnetonka MN 55345-1512
• For Additional Information Contact: Nic Raph; 952-465-3500
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: Augustine Temperature Management began notifying its consignees on 12/16/2024 via email and visit to exchange the affected product.
• Quantity in Commerce: 4 units
• Distribution: US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DWJ