Fresenius Medical Care Recalls Honeywell Pressure Transducers for Hemodialysis Systems
Fresenius Medical Care is recalling 3,561 Honeywell pressure transducers used in hemodialysis delivery systems due to lower long-term reliability.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text cites increased customer complaints regarding reliability without reporting specific injuries, illnesses, or hospitalizations, aligning with the criteria for a moderate severity score.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 3,561 units of the Honeywell Pressure Transducer, Part Number 370506-22. This component is used in several hemodialysis delivery systems, including the 2008T, 2008T HD SYS. BLUE STAR, 2008K2, and 2008K@home. The affected units were distributed nationwide in the United States.
The recall was initiated because the firm identified an increase in customer complaints regarding the lower long-term reliability of the part. As a result, the firm is replacing the pressure transducers with an improved design.
Healthcare facilities and users of the affected hemodialysis systems should check their equipment for the specific serial numbers listed in the recall notice. If a unit is affected, it should be replaced with the improved design provided by the manufacturer.
The recalled product
- Product
- Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hemodialysis Delivery Equipment; 2008K@home, Common Name: Hemodialysis Delivery System
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 3,561
Distribution
Distributed nationwide across the United States.
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