SafeStar 90 Plus Filter devices recalled for CO2 measurement defect
Draeger is recalling 669,838 SafeStar 90 Plus breathing filters due to a defect causing slow CO2 curve increases when gas samples are taken from the filter's sampling port.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, the agency's most serious classification. FDA Class I indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
Draeger, Inc. is recalling approximately 669,838 SafeStar 90 Plus Filter devices, bidirectionally breathing system filters distributed worldwide, including throughout the United States.
The filters are being recalled due to reports of slow increase of CO2-curve when gas samples are taken from the gas sampling port of the filters. This measurement defect could affect the accurate monitoring of respiratory function.
The affected devices are identified by Model No. MP05785 and UDI 04048675665762 (all lots). Healthcare facilities and other users should discontinue use of affected filters and contact Draeger, Inc. for replacement or return instructions.
The recalled product
- Product
- SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
- Manufacturer
- Draeger, Inc.
- Hazard
- co2-measurement-defect
- respiratory-monitoring-failure
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. MP05785
- UDI: 04048675665762
- All Lots.
Distribution
Distributed nationwide across the United States.
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