SafeStar 90 Plus breathing filters show a slow rising CO2 curve
SafeStar 90 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 gas sampling port. 669,838 units affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 SafeStar 90 Plus Filter, a bidirectionally breathing system filter, model number MP05785, UDI 04048675665762, is being recalled across all lots. The action covers 669,838 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
- SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
- Manufacturer
- Draeger, Inc.
- Affected units
- 669,838
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
Part of a larger recall action
This product is one of 4 recalled by Draeger, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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