FDA Medical devices recall ·
Augustine Surgical Inc recall
- Recall number
- Z-0700-2025
- Date
- (initiated December 4, 2024)
- Company / brand
- Augustine Temperature Management, LLC
15305 Minnetonka Blvd, Minnetonka, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 135 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it 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".
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) UDI-DI 00850011479018, Serial Numbers: 20080004-23060141; 2) UDI-DI 00850011479285, Serial Numbers: 20080004-23060141
Distribution
US and Canada
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0700-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.