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U.S. Department of Health and Human Services

Class 2 Device Recall NaturaLyte Liquid Acid

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  Class 2 Device Recall NaturaLyte Liquid Acid see related information
Date Initiated by Firm September 29, 2017
Create Date March 14, 2018
Recall Status1 Terminated 3 on August 09, 2018
Recall Number Z-1010-2018
Recall Event ID 79236
510(K)Number K070177  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0
3.43 liter bottle

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.
Code Information Lot # 17KTAC076; UDI-00840861101696
Recalling Firm/
Manufacturer		 Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact Beth St.Germain
800-227-2572
Manufacturer Reason
for Recall		 The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.
FDA Determined
Cause 2		 Release of Material/Component prior to receiving test results
Action The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated 10/4/2017 to its Consignees. The letter described the product, problem and actions to be taken. The Consignees are instructed to: " Immediately examine your stock to determine whether you have any Naturalyte¿ Liquid Acid Concentrate from the lot listed. " If any product 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. " Promptly fill out and return the attached Reply Form via fax to: 781-699-9796 ATTN: Quality Department or SCAN and email to: NOTIFYRA@fmc-na.com.' and "Route the letter to others in your organization that may have any of the affected product that is subject to this recall. Please note that the Naturalyte¿ Liquid Acid Concentrate matching the Lot Number listed in the notification is the only lot subject to this recall. If you have any additional medical concerns or questions, please contact Medical Information and Communication: 855-616-2309 or Website: www.fresenius-medinfo.com.
Quantity in Commerce 598 cases
Distribution US Distribution to states of: CA, FL, KS, LA, 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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