Z-0701-2025 Class II Ongoing
FDA device recall Z-0701-2025 was initiated by Augustine Temperature Management, LLC on December 4, 2024 and is designated Class II. 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"… The recall status is ongoing. Affected quantity: 1776 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2024
- Initiation Date
- December 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1776 units
Product Description
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
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".
Distribution Pattern
US and Canada
Code Information
1) UDI-DI 00850011479025, Serial Numbers: 20080060-24060065; 2) UDI/DI 00850011479292, Serial Numbers: 20080060-24060065; 3) UDI-DI 00850011479308, Serial Numbers: 20080060-24060065