Health Products

CombiStar, Safestar and TwinStar Filters/ HMEs

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Anaesthesiology
Product: CombiStar, Safestar and TwinStar Filters/ HMEs
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Filter/HME TwinStar PlusAll lots.MP05801
Filter SafeStar 90 PlusAll lots.MP05785
Filter SafeStar 55 PlusAll lots.MP05790
CombiStar Plus Filter + HME Hepa FlexAll lots.MP12062
Filter SafeStar 60A PlusAll lots.MP05795

Issue

Users have reported a slow increase of the CO2-curve when the gas sample line of the gas measurement of a Dräger anesthesia machine is connected to the gas sampling port of the affected filters/HME. The comparatively slower increase in the CO2-curve only occurs when the gas sample line is connected to the gas sampling port of an affected filter/HME. Other setups are not affected. Recall start date: May 23, 2025

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