Product Wiki · Recalls · Health Canada — Medical Devices

VentStar Helix heated, dual heated (2019-03-27) — recall 59328

Health Canada — Medical Devices · Canada · 2019-04-09 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
59328
Date of alert
2019-04-09
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Several cases have come to Draeger's attention in which cracks have formed in the breathing hose during ventilation. If a crack forms in the breathing hose during operation, a leak will result that can negatively affect ventilation of the patient. If the breathing circuit is used with devices listed as compatible in the Instructions for Use, any leakages will be detected and the device will give an alarm.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ventstar-helix-heated-dual-hea

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