Recall Z-0153-2023
Belmont Instrument Corporation · initiated July 20, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CritiCool, thermoregulation device
Codes / lots: 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 9982315400005 9982315400007 99110992900003 99110992900004 99110992900005 9964294500014 99102316800010 9999186600018 9999186600020 99100663300024 9974085100004 9989990200007 9995355500007 9974085100001 9974085100005…
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: Component design/selection
Action taken
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
Details
- Recall number
- Z-0153-2023
- Initiated
- July 20, 2021
- Posted by FDA
- October 31, 2022
- Product code
- DWJ – System, Thermal Regulating
- Quantity
- 158 (US); 803 (OUS)
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Recalling firm
- Belmont Instrument Corporation, Billerica, MA