Draeger, Inc. is recalling approximately 11,949,459 SafeStar and TwinStar breathing system filters because the carbon dioxide (CO2) monitoring function may fail. The affected products include SafeStar 90 Plus, SafeStar 55 Plus, SafeStar 60A Plus, and HME TwinStar HEPA Plus models. When gas samples are taken from the filter's sampling port, the CO2 curve may increase too slowly, resulting in inaccurate readings for patients. No injuries have been reported in connection with this defect, and Draeger is notifying customers by letter.
A slow increase in the CO2 curve can lead to inaccurate monitoring of a patient's respiratory status. This could cause healthcare providers to misinterpret carbon dioxide levels, potentially leading to delayed medical interventions or improper treatment.
Recall #: Z-2158-2025; Quantity: 669,838 units.
Recall #: Z-2159-2025; Quantity: 9,885,139 units.
Recall #: Z-2160-2025; Quantity: 1,019,782 units.
Recall #: Z-2161-2025; Quantity: 374,700 units.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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