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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 concentratesee related information
Date Initiated by FirmOctober 04, 2022
Date PostedNovember 04, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0181-2023
Recall Event ID 90947
510(K)NumberK070177 
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
ProductNaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Code Information UDI-DI: 00840861101610 Lots: 20LTAC076 20PTAC094 21ATAC046 21BTAC082 21CTAC029 21KTAC072 21PTAC023 21STAC094 22DTAC036
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 950
Waltham MA 02451-1521
For Additional Information ContactFresenius Medical Care Technical Service
800-227-2572
Manufacturer Reason
for Recall		The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.
FDA Determined
Cause 2		Error in labeling
ActionOn October 4, 2022, the firm notified affected customers via Important Medical Device Information letters. Customers were reassured that the product was manufactured according to specification and remains potassium-free. Customers may continue to use the product. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have further questions.
Quantity in Commerce17700
DistributionDomestic distribution to AL AZ CA DC FL GA HI IL IN MD MI MO MS NE NJ NY OH PA SD TX VA No foreign distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KPO
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