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U.S. Department of Health and Human Services

Class 1 Device Recall Naturalyte Liquid Bicarbonate Concentrate

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  Class 1 Device Recall Naturalyte Liquid Bicarbonate Concentrate see related information
Date Initiated by Firm April 10, 2014
Date Posted May 22, 2014
Recall Status1 Open3, Classified
Recall Number Z-1639-2014
Recall Event ID 67922
510(K)Number K071387  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle
Part Number: 08-4000-LB

The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates
Code Information Lot Numbers (49 lots) recalled on 4/10/14:, 13KMLB001, 13LMLB001, 14AMLB002, 13KMLB002, 13LMLB002, 14AMLB003, 13KMLB003, 13LMLB003, 14AMLB004, 13KMLB004, 13LMLB004, 14AMLB005, 13KMLB005, 13LMLB005, 14AMLB006, 13KMLB006, 13LMLB006, 14AMLB007, 13KMLB007, 13LMLB007, 14AMLB008, 13KMLB008, 13LMLB008, 14AMLB009, 13KMLB009, 13LMLB009, 14AMLB010, 13KMLB010, 13LMLB010, 14AMLB012, 13KMLB011, 13LMLB011, 13JMLB005, 13KMLB012, 13LMLB012, 13JMLB008, 13KMLB013, 13LMLB013, 13JMLB006, 13KMLB014, 13LMLB014, 13JMLB007, 13KMLB015, 13LMLB015, 13JMLB004, 13KMLB016, 13LMLB016, 13KMLB017, 14AMLB001, Expanded Recall (9 lots):, 13LMLB005, 13LMLB006, 14AMLB011, 14AMLB013, 14AMLB014, 14AMLB015, 14AMLB016, 14AMLB017, 14BLMB001
Recalling Firm/
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
Manufacturer Reason
for Recall
Naturalyte Liquid Bicarbonate maybe contaminated
FDA Determined
Cause 2
Under Investigation by firm
Action Fresenius Medical Care North America issued an Urgent Medical Device Recall Letter dated April 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their stock immediately and determine whether they have any of the affected parts on hand. If customers have the affected product, they were instructed to discontinue use and place all Naturalyte Liquid Bicarbonate Concentrate in a secure area for return to Fresenius Medical Care Renal Therapies Group, LLC (FMC-RTG). Customers will be instructed to contact their Fresenius Medical Care Technical Services Team for instructions on how to return the recalled product. Firm will also conduct 100% telephone calls. If you have any additional questions, please contact your FMCNA Customer Service Team at 1-800-323-5188. Fresenius Medical Care sent an Urgent Expanded Medical Device Recall letter on May 1, 2014 for 9 additional lots. Customers were instructed to complete and return the attached FAX BACK FORM to confirm that they have received the notice and to indicate whether or not they have the affected product in their possession. For questions regarding this recall call 800-662-1237. Firm issued Press on 5/21/14.
Quantity in Commerce 672,784 units
Distribution Worldwide Distribution - USA (nationwide) and Canada.
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