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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 FirmFebruary 15, 2024
Date PostedFebruary 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1171-2025
Recall Event ID 95914
510(K)NumberK210727 K230866 
Product Classification System, thermal regulating - Product Code DWJ
ProductAugustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.
Code Information UDI-DI 00855913001794, Lot Number 2122
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		Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
FDA Determined
Cause 2		Device Design
ActionAugustine Temperature Management contacted their consignees by visit beginning on 02/15/2024 to replace the affected cables. The firm collected email confirmation that the original cables had either been returned or destroyed. If you have any questions, contact the Product Manager at 952-465-3526 or email:
Quantity in Commerce20 units
DistributionUS distribution to states of: AL, TX, NV
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.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DWJ
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