FDA recall Z-1529-2020

Fresenius Medical Care Holdings, Inc. · Class II · device

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

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.

Distribution

US Nationwide distribution.

Key facts

Status: Terminated
Initiation date: 2020-01-29
Report date: 2020-04-01
Termination date: 2021-01-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1529-2020