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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