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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 June 01, 2022
Create Date July 01, 2022
Recall Status1 Completed
Recall Number Z-1311-2022
Recall Event ID 90419
510(K)Number K192017  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Code Information UDI: (01)00840861101702 (17) 230131 (10) 21AGAC009 Lot 21AGAC009
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 950
Waltham MA 02451-1521
For Additional Information Contact Fresenius Medical Care Customer Service
800-323-5188
Manufacturer Reason
for Recall		 The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.
FDA Determined
Cause 2		 Under Investigation by firm
Action On June 1, 2022, the firm reached out to its affected customers via telephone to explain the product issue. Customers were instructed to identify and segregate the affected product immediately and remove the product from inventory. If customers had any product to return, the recalling firm would have a customer service representative follow up with the customer. Customers were reminded to always inspect packaging for leaks.
Quantity in Commerce 3 cases
Distribution US Nationwide distribution in the states of Texas and Louisiana.
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.
510(K) Database 510(K)s with Product Code = KPO and Original Applicant = Fresenius Medical Care Renal Therapies Group, LLC
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