Recall Z-1529-2020— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-1529-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-29

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2020-01-29, terminated 2021-01-06. It names 2 FDA 510(k) clearances: K173972, K153449. 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: 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..

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-01-29
Terminated: 2021-01-06
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K173972 — 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC·cleared 2018-05-10
K153449 — 2008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC·cleared 2016-04-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.