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 NaturaLyte

  • 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 NaturaLytesee related information
Date Initiated by FirmMay 20, 2015
Date PostedJune 22, 2015
Recall Status1 Terminated 3 on November 03, 2026
Recall NumberZ-1827-2015
Recall Event ID 71160
510(K)NumberK071387 
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
ProductNaturaLyte 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.  
FEI Number 3001451489
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
800-662-1237
Manufacturer Reason
for Recall		Bacterial contamination.
FDA Determined
Cause 2		Process control
ActionFresenius 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 Commerce1,856,619 Bottles
DistributionNationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KPO
-
-