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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius Medical Care

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 Class 2 Device Recall Fresenius Medical Caresee related information
Date Initiated by FirmDecember 17, 2020
Create DateFebruary 01, 2021
Recall Status1 Terminated 3 on January 05, 2023
Recall NumberZ-0942-2021
Recall Event ID 87006
510(K)NumberK070177 
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
ProductFresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
Code Information Lot code: 20NTAC040
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		Bottles Missing Product Label
FDA Determined
Cause 2		Packaging change control
ActionFresenius Medical Care (FMCRTG isssued URGENT MEDICAL DEVICE RECALL on 12/17/20 ia First Class Mail, letter states reason for recall, health risk and action to take: RETURN ONLY BOTTLES WITH NO LABEL OPEN AND CHECK ALL BOTTLES IN CASES of Lot Number 20NTAC040. " If you find any bottles from this lot with no labels, place the product in a secure, segregated area. Please contact FMCRTG Customer Service at 1-800-323-5188 for instructions on how to return the product and receive credit. o If returning single bottles, please place affected product in a box for pick up. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have unique circumstances or an urgent need concerning product delivery.
Quantity in Commerce2,280 cases (9,120 bottles)
DistributionNationwide
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KPO
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