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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius Naturalyte Liquid Acid Concentrate

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  Class 2 Device Recall Fresenius Naturalyte Liquid Acid Concentrate see related information
Date Initiated by Firm January 18, 2016
Date Posted February 25, 2016
Recall Status1 Terminated 3 on August 14, 2017
Recall Number Z-0887-2016
Recall Event ID 73077
510(K)Number K070177  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product Fresenius Naturalyte Liquid Acid Concentrate
Catalog Number: 08-2301-3

Intended Use: Acid Concentrate for Bicarbonate Dialysis
Code Information Lot Number: 15STAC072 Exp Date: 2017-12-31
Recalling Firm/
Manufacturer		 Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
781-699-9000
Manufacturer Reason
for Recall		 On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.
FDA Determined
Cause 2		 Error in labeling
Action The firm, Fresenius Medical Care, issued an "URGENT-MEDICAL DEVICE RECALL" letter dated 1/14/2015 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your stock for the product; if found, discontinue use immediately; place all units in a secure, segregated area; contact your FMCNA Customer Service Team at 1-800-323-5188 for instructions how to return the affected lot (lot# 15STAC072), and promptly complete and return the attached reply form by Fax to: 781-699-9796 Attn: Quality Department or scan and email to: NOTIFYRA@fmc-na.com. Fresenius will pick up and replace your product. If you have any additional medical concerns or questions, please contact Medical Information and Communication at 855-816-2309 or Website: www.fresenius-medinfo.com. Further information or support concerning this issue, contact the Customer Service Care Team at 800-323-5188 and reference the and Support Field Action Number.
Quantity in Commerce 848 (212 cases)
Distribution US Distribution to states of: KS, LA, MS, OK, and TX.
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 = KPO and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
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