Medical device recalls Moderate risk

Fresenius Medical Care Holdings, Inc. recalls Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Deliv…

Recall date
January 29, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1529-2020
FDA classification
Class II
Brand / firm
Fresenius Medical Care Holdings, Inc.
Sold / distributed
US Nationwide distribution.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

Get recall alerts

Free email alert whenever Fresenius Medical Care Holdings, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Fresenius Medical Care Holdings, Inc.