Health product recall

CombiStar, SafeStar and TwinStar Filters/ HMEs

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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