Draeger recalls HME TwinStar HE:PA Plus filters due to slow CO2 curve increases in gas samples. Affected units include all lots of model MP05801. No remedy specified in recall notice.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Draeger is recalling all HME TwinStar HEPA Plus filters (model MP05801) because gas samples from the filter show a slow increase in CO2 levels. This could lead to inaccurate breathing measurements in medical devices, potentially affecting patient safety.
The filter may cause a slow rise in CO2 levels when gas is sampled, leading to inaccurate readings. This could result in improper treatment decisions for patients on ventilators. The hazard occurs during routine gas sampling procedures.
Healthcare professionals using the filter in medical ventilators or breathing systems are most at risk. Patients using these devices could be affected if the filter malfunctions.
Check for the model number MP05801 on the filter. All lots of this filter are affected. The unique device identifier (UDI) is 04048675665823.
Look for the model number MP05801 on the filter to confirm it is affected.
The recall notice does not specify any remedy.
Check for the model number MP05801 on the filter. All lots of this filter are affected.
The recall notice does not specify any action steps.
We’ve drafted a message you can send Draeger to request your refund or repair — edit it as you like.
Subject: Recall Z-2160-2025 — Draeger Draeger Hello, I own a Draeger that is covered by recall Z-2160-2025 from Draeger. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
