Drager SafeStar 55 Medical Devices Recalled for Possible Filter Occlusion
Draeger Medical is recalling approximately 35,950 Drager SafeStar 55 medical devices due to a manufacturing error that may cause occlusion of the device's filters, potentially preventing proper device function.
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: This recall is classified FDA Class I, the highest priority medical device recall classification. FDA Class I mandates a minimum severity score of 4 per the rubric. No deaths or reported illnesses have been documented in the source material.
Plain-English summary
Draeger Medical, Inc. is recalling approximately 35,950 Drager SafeStar 55 medical devices (Catalog No. MP01790) due to a manufacturing error that may cause occlusion of the device's filters. This could prevent the device from functioning properly.
The recalled devices have been distributed worldwide and across 23 U.S. states, including Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, North Dakota, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington, and West Virginia. The affected lot number is LT2103 (UDI-DI: 04048675026785).
Affected customers and healthcare facilities should contact Draeger Medical, Inc. for information regarding their recalled devices.
The recalled product
- Product
- Drager SafeStar 55, Catalog No. MP01790
- Manufacturer
- Draeger Medical, Inc.
- Category
- Medical Device
- Affected units
- 35,950
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 (2)
- UDI-DI: 04048675026785
- Lot No. LT2103.
Distribution
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