SafeStar 55 Plus breathing filters recalled for CO2 monitoring defect
Draeger SafeStar 55 Plus breathing system filters are being recalled due to reports of slow CO2 curve increases when gas samples are taken from the filter's sampling port.
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 medical device recall with no reported illnesses or injuries. The hazard involves a monitoring defect in a critical respiratory support device. Classification as Class I requires a minimum score of 4.
Plain-English summary
Draeger, Inc. has initiated a recall of the SafeStar 55 Plus Filter, a bidirectionally breathing system filter used in respiratory applications. Approximately 9.9 million units are affected globally, with distribution across the United States and internationally.
The recall follows reports of slow increase of CO2-curve readings when gas samples are taken from the gas sampling port of the filters. All lot numbers of the product are included in this recall.
The affected product is identified by Mode Number MP05790 and UDI 04048675558736. Healthcare facilities and providers currently using this filter should contact Draeger, Inc. for further information and guidance regarding verification, inspection, and replacement options.
The recalled product
- Product
- SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
- Manufacturer
- Draeger, Inc.
- Hazard
- measurement-delay
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)
- Mode No. MP05790
- UDI: 04048675558736
- All Lots.
Distribution
Distributed nationwide across the United States.
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