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U.S. Department of Health and Human Services

Class 2 Device Recall Honeywell Pressure Transducer

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  Class 2 Device Recall Honeywell Pressure Transducer see related information
Date Initiated by Firm January 29, 2020
Create Date March 20, 2020
Recall Status1 Terminated 3 on January 06, 2021
Recall Number Z-1529-2020
Recall Event ID 84945
510(K)Number K153449  K173972  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
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
Code Information Serial numbers 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Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 950
Waltham MA 02451-1521
For Additional Information Contact Fresenius Medical Care Technical Service
800-227-2572
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
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.
Quantity in Commerce 3561 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
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