Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Fresenius see related information
Date Initiated by Firm May 29, 2019
Create Date August 05, 2019
Recall Status1 Terminated 3 on November 19, 2020
Recall Number Z-2151-2019
Recall Event ID 83164
510(K)Number K173718  
Product Classification System, peritoneal, automatic delivery - Product Code FKX
Product Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows:
(1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212
(2) LIBERTY Line Cycler Set with Stay-safe connectors (Single Patient Connector) Part Number: 050-87215
(3) LIBERTY Integrated Cycler Set with single Stay-safe patient connector and extended drain line Part Number: 050-87216
Code Information All lots
Recalling Firm/
Manufacturer		 Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St
Waltham MA 02451-1521
Manufacturer Reason
for Recall		 Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler and is a potential risk for contamination.
FDA Determined
Cause 2		 Use error
Action Fresenius issued on 05/29/19 The IMPORTANT MEDICAL DEVICE INFORMATION notification explains to the Home Therapy Nurses/Clinics to review the new flyer with each of their APD patients who use a Liberty Cycler. For the patient notification, it will encourage them to use and follow the attached instructional flyer during set up for their daily dialysis treatment. The notification will have a copy of the new step-by-step instructional flyer. Included is a Reply Form for confirmation the consignee read and understands the notice sent to them.
Quantity in Commerce 33732973 Cassettes; 18,674 Liberty Cyclers
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 = FKX and Original Applicant = Fresenius Medical Care Renal Therapies Group, LLC
-
-