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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

FDA Recall Z-1529-2020 · Posted None

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2020-01-29
Date Terminated2021-01-06
Product Quantity3561 units

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.

Firm Action

Starting October 7, 2019, the firm began implementing the improved Pressure Transducers into machine production. On January 29, 2020, the firm's Technical Services began contacting clinics via phone call on to set up appointments for transducer replacements for 2008T and 2008T Blue Star machines affected by the recall. Customers may also contact FMCRTG Technical Service at 800-227-2572.

Root Cause

Component design/selection

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2018-05-10K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC · 2016-04-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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