PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 1, 2020 Initiated: January 29, 2020 #Z-1529-2020

Product Description

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

Reason for Recall

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.

Details

Units Affected
3561 units
Distribution
US Nationwide distribution.
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
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. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 3561 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 1, 2020. Severity: Moderate. Recall number: Z-1529-2020.