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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius NaturaLyte

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  Class 2 Device Recall Fresenius NaturaLyte see related information
Date Initiated by Firm May 20, 2015
Date Posted June 22, 2015
Recall Status1 Open3, Classified
Recall Number Z-1827-2015
Recall Event ID 71160
510(K)Number K071387  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle
Catalog Number: 08-4000-LB
This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Code Information Affected lots begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB.  
Recalling Firm/
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
Manufacturer Reason
for Recall
Bacterial contamination.
FDA Determined
Cause 2
Process control
Action Fresenius Medical Care sent an Urgent Medical Device Recall letter dated May 15, 2015, to all affected customers. Users were requested to Immediately examine stock to determine whether they have any Naturalyte¿ Liquid Bicarbonate Concentrate of the lots. " If any product of these lots is found, discontinue use immediately. " Place all units in a secure, segregated area. " If affected product was on the machine prior to patient treatment, perform a [Heat Disinfect] program. " Your dialysis schedule should not be interrupted. If interruption of your dialysis schedule is expected, please discuss your options with your health care provider. " Contact FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product. " Promptly fill out and return the attached reply form Additional medical concerns or questions, please contact Medical Information and Communication: 855-616-2309 or Website: www.fresenius-medinfo.com. For questions regarding this recall call 800-662-1237.
Quantity in Commerce 1,856,619 Bottles
Distribution 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KPO and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA