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U.S. Department of Health and Human Services

Class 2 Device Recall Hillrom

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 Class 2 Device Recall Hillromsee related information
Date Initiated by FirmDecember 04, 2024
Date PostedDecember 18, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0702-2025
Recall Event ID 95703
510(K)NumberK201779 K220941 
Product Classification System, thermal regulating - Product Code DWJ
ProductHillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Code Information UDI-DI 00850011479582, Serial Numbers: 22120000-24030030
Recalling Firm/
Manufacturer		 Augustine Temperature Management, LLC
15305 Minnetonka Blvd
Minnetonka MN 55345-1512
For Additional Information ContactNic Raph
952-465-3500
Manufacturer 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".
FDA Determined
Cause 2		Device Design
ActionAugustine Temperature Management issued a Field Notification to its consignees on 12/04/2024 via email. The notice explained the issue, potential risk, and advised that there is an update to the User and Technical Manual to further clarify existing instructions for the device. If the device was further distributed, those distributing the device were directed to notify those to whom the device was distributed. Consignees are expected to respond via email. An optional power board update is available. For questions or concerns, contact: customercare@augsurg.com or by telephone, 952-465-3500, fax, 952-465-3501, 8AM - 5PM Central time.
Quantity in Commerce116 units
DistributionUS and Canada
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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