Augustine Temperature Management, LLC: Device Recall

Recall Details

Recall Number

Z-0700-2025

Classification

Class II

Product Type

Device

Recalling Firm

Augustine Temperature Management, LLC

Status

Ongoing

Date Initiated

12/04/2024

Location

Minnetonka, MN, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

135 units

Reason for Recall

Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".

Product Description

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

Distribution Pattern

US and Canada

Other Recalls by Augustine Temperature Management, LLC

• Class II: Risk 12/16/2024
  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.
• Class II: Risk 12/16/2024
  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.
• Class II: Risk 12/16/2024
  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.
• Class II: Risk 12/04/2024
  Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".
• Class II: Risk 12/04/2024
  Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".

View all recalls by Augustine Temperature Management, LLC →