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.
What this means for you
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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