HME TwinStar HEPA Plus filters show a slow rising CO2 curve
HME TwinStar HEPA Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 1,019,782 units affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.
Plain-English summary
The HME TwinStar HEPA Plus Filter, a bidirectionally breathing system filter, model number MP05801, UDI 04048675665823, is being recalled across all lots. The action covers 1,019,782 units.
The stated reason is reports of a slow increase of the CO2 curve when the gas sample is taken from the gas sampling port of the filters. The FDA classified the action as Class I, its most serious classification.
Distribution was worldwide, including nationwide in the United States across Alaska, Arizona, California and Colorado among other states. The filters are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model number and UDI above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
- Manufacturer
- Draeger, Inc.
- Hazard
- co2-monitoring
- gas-sampling
- capnography
- class-i
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. MP05801
- UDI: 04048675665823
- All Lots.
Distribution
Distributed nationwide across the United States.
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