Augustine HOT DOG Temperature Management Controller Instructions Update
Augustine Temperature Management is issuing an instructions for use update for its HOT DOG warming controllers (Models WC77, WC77D, WC77R) regarding a power-on self-test error code.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II device recall with no reported illnesses, injuries, or hospitalizations. The issue is an instructions for use update regarding a power-on self-test error code, representing a documentation correction or precautionary measure.
Plain-English summary
Augustine Temperature Management, LLC is updating the instructions for use for its HOT DOG patient warming controllers due to a power-on self-test error code issue.
The update pertains to Models WC77, WC77D (Demo), and WC77R (Refurbished), which are temperature management controllers used in conjunction with warming blankets and mattresses. A total of 1,776 units have been distributed in the US and Canada.
The instructions for use update specifically addresses the power-on self-test error code 'EA POST' in the affected models.
The recalled product
- Product
- 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.
- Manufacturer
- Augustine Temperature Management, LLC
- Affected units
- 1,776
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 1) UDI-DI 00850011479025
- Serial Numbers: 20080060-24060065
- 2) UDI/DI 00850011479292
- 3) UDI-DI 00850011479308
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Augustine Temperature Management, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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