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U.S. Department of Health and Human Services

Class 2 Device Recall CritiCool

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  Class 2 Device Recall CritiCool see related information
Date Initiated by Firm July 20, 2021
Date Posted October 31, 2022
Recall Status1 Open3, Classified
Recall Number Z-0153-2023
Recall Event ID 90939
510(K)Number K083662  
Product Classification System, thermal regulating - Product Code DWJ
Product CritiCool, thermoregulation device
Code Information UDI-DI: 07290107581110 Serial Numbers: 9978580900011 99110698100043 99110698100044 9963715800012 9982077400003 9971040500004 9982294100006 9964294500006 9963715800008 9964294500007 9978580900008 9978580900009 9999186600019 99110008800035 99110008800036 99109321700020 99109321700026 99110992900020 99100663300011 99100663300014 99101637500005 99110698100048 9966227400007 9966227400012 9989990200008 9995915300007 9995915300014 9966227400008 9966227400011 9969231000003 9969231000004 9969231000005 9969570100004 9969570100014 9969570100018 99108208900030 99109321700010 9989990200012 99110992900011 9974072400005 99102316800013 9974085100011 9995355700003 99108208900023 99108208900025 996622740007 9969570100016 99104180900007 99107291500013 99107291500016 9983874900002 99108208900022 99109321700004 9978471200014 99100663300013 99100663300023 9995355500001 9995355500001 9995355500003 9995355500003 9996480200001 99104183000019 99104183000021 99110698100028 99110698100029 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Recalling Firm/
Manufacturer		 Belmont Instrument Corporation
780 Boston Rd
Billerica MA 01821-5925
For Additional Information Contact Lida Reed
978-663-0212
Manufacturer Reason
for Recall		 Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue.
FDA Determined
Cause 2		 Component design/selection
Action On September 28, 2022, the firm issued Urgent Medical Device Recall letters to affected customers. If the device is operating properly, customers may continue to use the device as intended with increased oversight during use while awaiting inspection and repair. The customer was provided with actions to take if a HALT 4 message is displayed on the device. While customers wait for their devices to be inspected and repaired, Belmont Medical Technologies recommends that you evaluate your clinical needs and consider planning for alternative methods of thermoregulation in case of failure. Belmont Medical Technologies will dispatch service technicians to customer sites to inspect and repair affected CritiCool devices. Customers will be contacted by the service technician to schedule a convenient time for the inspection and repair of customer devices. For any questions regarding this action, technical assistance or to report an adverse event or product complaint, please contact Belmont Medical Technologies using the following information: 1-855-387-4547 TECHSUPPORT@BELMONTMEDTECH.COM
Quantity in Commerce 158 (US); 803 (OUS)
Distribution Domestic distribution nationwide. Foreign distribution worldwide.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DWJ and Original Applicant = MTRE ADVANCED TECHNOLOGY LTD.
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