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U.S. Department of Health and Human Services

Class 2 Device Recall Augustine Surgical

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 Class 2 Device Recall Augustine Surgicalsee related information
Date Initiated by FirmMarch 14, 2022
Date PostedJanuary 10, 2025
Recall Status1 Completed
Recall NumberZ-0839-2025
Recall Event ID 95913
510(K)NumberK201779 K220941 
Product Classification System, thermal regulating - Product Code DWJ
ProductAugustine 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.
Code Information 1) UDI-DI 00850011479018, Serial Numbers: 23060144, 22030085, 22030087, 22030088, 23060138, 23060139, 22030075, 22030076, 22030077, 22030079, 22030080, 22030081, 22030082, 22030083, 22030084, 23060141; 2) UDI-DI 00850011479285, Serial Numbers: 20080002
FEI Number 3005857264
Recalling Firm/
Manufacturer		 Augustine Temperature Management, LLC
15305 Minnetonka Blvd
Minnetonka MN 55345-1512
For Additional Information ContactNic Raph
952-465-3526
Manufacturer 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".
FDA Determined
Cause 2		Device Design
ActionAugustine Temperature Management, LLC began correcting (installing ferrites and software updates) the affected devices February, 2022 and completed the actions in August 2023. The firm did not perform any notification to its consignees that corrections would be implemented.
Quantity in Commerce17 units
DistributionWorldwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = DWJ
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