SafeStar 60A Plus Filter recall for inaccurate CO2 gas sampling readings
Draeger's SafeStar 60A Plus Filter may display slow CO2 curve increases during gas sampling, potentially causing inaccurate ventilation monitoring. The FDA is recalling 374,700 units distributed worldwide.
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. Per the severity rubric, FDA Class I recalls are classified as Critical. Class I indicates a serious potential hazard where use of the product could cause serious adverse health consequences. The malfunction affects CO2 gas sampling accuracy during patient monitoring in respiratory equipment, which is critical for safe clinical decision-making.
Plain-English summary
SafeStar 60A Plus Filter is a bidirectional breathing system filter manufactured by Draeger, Inc. This recall affects approximately 374,700 units distributed worldwide, including across all US states and numerous countries. All lots of Model No. MP05795 (UDI: 04048675665786) are included in this FDA Class I recall.
Reports indicate that when gas samples are taken from the gas sampling port of these filters, there is a slow increase in the CO2 curve reading. This malfunction may result in inaccurate CO2 measurements during patient monitoring, which could affect clinical decision-making for ventilation management.
Healthcare facilities and clinical settings using these filters should immediately discontinue use and contact Draeger, Inc. for guidance on inspection, replacement, or removal of affected units from service. Users should verify their equipment serial numbers and lot codes against the recall notice to determine whether they have received affected units.
The recalled product
- Product
- SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
- Manufacturer
- Draeger, Inc.
- Hazard
- gas-sampling-error
- measurement-error
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. MP05795
- UDI: 04048675665786
- All Lots.
Distribution
Distributed nationwide across the United States.
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