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U.S. Department of Health and Human Services

Class 2 Device Recall NaturaLyte Liquid Acid Concentrate

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  Class 2 Device Recall NaturaLyte Liquid Acid Concentrate see related information
Date Initiated by Firm May 02, 2018
Create Date June 07, 2018
Recall Status1 Terminated 3 on May 13, 2020
Recall Number Z-2110-2018
Recall Event ID 80101
510(K)Number K070177  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1

Product Usage:
This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used.
Code Information Lot Code: 18CXAC095
Recalling Firm/
Manufacturer		 Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
800-227-2572
Manufacturer Reason
for Recall		 The bottles are mislabeled with an incorrect part number.
FDA Determined
Cause 2		 Employee error
Action Phone calls and Urgent Medical Device Recall notification letters were issued on 5/2/18. Customers were instructed to do the following: Immediately examine your stock to determine whether you have any NaturaLyte Liquid Acid from the lot listed above. If any products of this lot is found, discontinue use immediately. Place all units in a secure, segregated area. Contact your FMCRTG, LLC Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product and arrange for replacement product. Promptly fill out and return the attached reply form.
Quantity in Commerce 1060 cases (4240 bottles)
Distribution Worldwide Distribution - US Nationwide in the states: CA, IA, IL, IN, KS, MD, MI, MN, MS, NE, NJ, NV, OK, PA, SD, TX, and WI.
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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