CombiStar, SafeStar and TwinStar Filters/ HMEs
Brand(s)
Last updated
Summary
Product
CombiStar, SafeStar and TwinStar Filters/ HMEs
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products | Lot or serial number | Model or catalogue number |
---|---|---|
Filter/HME TwinStar Plus | All lots. | MP05801 |
Filter SafeStar 90 Plus | All lots. | MP05785 |
Filter SafeStar 55 Plus | All lots. | MP05790 |
CombiStar Plus Filter + HME Hepa Flex | All lots. | MP12062 |
Filter SafeStar 60A Plus | All 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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Draegerwerk Ag & Co. Kgaa |
Moislinger Allee 53-55, Lubeck, Germany, 23542 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77579
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