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Filter hme twinstar plus
Official notice
4 Aug 2023
Last checked
4 Aug 2023
An official Health Canada notice concerns Filter hme twinstar plus. Manufacturer's market surveillance activities revealed cases of increased inspiratory resistance resulting in insufficient ventilation, which may be related to formation of condensate in the filter housing. Device is intended exclusively for single patient use no longer than 24 hours. Excessive condensation can significantly shorten the period of use of the device and require the product to be replaced latest after 24 hours. Increased resistance carries the risk of desaturation for the patient. Should this hazardous situation encounter, consider the possibility that it may be related to the occlusion of the filter due to condensate. The current instructions for use contain warnings related to condensate. However, manufacturer has determined that the instructions can be further improved. Until the revised instructions for use are available customers may continue using the device as long as both airway pressure and volume are permanently monitored and alarm limits for each patient are suitably selected. Change of filter is required in the case of resistance increase. Recall start date: July 24, 2023 Published 2023-08-04.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74068
Official notice
2023-08-04
The hazard
The hazard
Manufacturer's market surveillance activities revealed cases of increased inspiratory resistance resulting in insufficient ventilation, which may be related to formation of condensate in the filter housing. Device is intended exclusively for single patient use no longer than 24 hours. Excessive condensation can significantly shorten the period of use of the device and require the product to be replaced latest after 24 hours. Increased resistance carries the risk of desaturation for the patient. Should this hazardous situation encounter, consider the possibility that it may be related to the occlusion of the filter due to condensate. The current instructions for use contain warnings related to condensate. However, manufacturer has determined that the instructions can be further improved. Until the revised instructions for use are available customers may continue using the device as long as both airway pressure and volume are permanently monitored and alarm limits for each patient are suitably selected. Change of filter is required in the case of resistance increase. Recall start date: July 24, 2023
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
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Affected area 1
Company & contacts
Company & contacts
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Manufacturer
Phone
Brand: Draegerwerk Kgaa, Filter Hme Twinstar Plus.
Source & status
Source & status
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Tier
Category
Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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