Recall Z-0840-2025— Augustine Temperature Management, LLC
Class II · Completed
Class II FDA medical device recall by Augustine Temperature Management, LLC, initiated 2022-03-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.. Reason: HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST"..
- Recalling firm
- Augustine Temperature Management, LLC
- Classification
- Class II
- Status
- Completed
- Initiated
- 2022-03-14
- Firm location
- Minnetonka, MN, United States
Product description
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
Reason for recall
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
Data sourced from openFDA. This site is unofficial and independent of the FDA.