Product Wiki · Recalls · Health Canada — Medical Devices

Stockert Heater Cooler System 3T (2018-10-28) — recall 58482

Health Canada — Medical Devices · Canada · 2018-11-15 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
58482
Date of alert
2018-11-15
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: LivaNova is providing updated instructions to monitor the concentration of hydrogen peroxide in the water circuit of the 1T and 3T Heater-Cooler devices, to verify that sufficient concentration of hydrogen peroxide is present to limit microbial growth, and to adjust the concentration of hydrogen peroxide if it drops below 100 ppm. This regimen enhances the water maintenance regimen outlined in Section 6.4 of the operating instructions.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/stockert-heater-cooler-system-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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