Reported Dec 25, 2024 · Ongoing

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models

Augustine Temperature Management, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Augustine Temperature Management, LLC · 15305 Minnetonka Blvd · Minnetonka, MN · 55345-1512

Is this the product you have?

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models

3 of 3 products

Products covered by this recall
Model / numberProduct as published
WC77
WC77D(Demo)
WC77R(Refurbished); used in conjunction with Warming Blankets and Mattresses.
Lot codes and dates
  • 1) UDI-DI 00850011479025
  • Serial Numbers
    • 20080060-24060065
    • 2) UDI/DI 00850011479292
  • Serial Numbers
    • 20080060-24060065
    • 3) UDI-DI 00850011479308
  • Serial Numbers20080060-24060065
Amount recalled
1776 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Why it was recalled

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".

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:53 PM UTC

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