FDA-Device2020-04-01Class II
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
Fresenius Medical Care Holdings, Inc.
Hazard
The firm is replacing pressure transducers with an improved design due to an increase in customer complaints regarding lower long-term reliability of the part.
Sold states
US Nationwide distribution.
Affected count
3561 units
Manufactured in
920 Winter St Bld 950, N/A, Waltham, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1529-2020Don't want to check this manually?
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