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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius

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  Class 2 Device Recall Fresenius see related information
Date Initiated by Firm May 31, 2022
Create Date July 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-1371-2022
Recall Event ID 90438
510(K)Number K192017  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure
Part Number: 08-3301-2
Code Information UDI-DI: (01) 10840861101757  (17) 240331  (10) 22CTAC102  Lot Number: 22CTAC102 Exp Date: 2024-03-31
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 950
Waltham MA 02451-1521
For Additional Information Contact SAME
781-6999580
Manufacturer Reason
for Recall		 Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
FDA Determined
Cause 2		 Under Investigation by firm
Action Fresenius Medical Care issued Urgent Medical Device Recall letter (FA-2022-11-T) dated 6/2/22. Letter states reason for recall, health risk and action to take: These instructions apply only to clinics directly contacted by the Fresenius Medical Care Corrections and Removals Department. " Immediately examine your stock to determine whether you have NaturaLyte¿ Liquid Acid concentrate with the part and lot numbers listed below. " Only bottles with sealed for your protection on the bottle cap foil are affected (see picture below). " Remove the affected product from your inventory. " FMCRTG, LLC will contact you regarding product return. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have any further questions.
Quantity in Commerce 163 cases
Distribution Natiowide
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 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) Database 510(K)s with Product Code = KPO and Original Applicant = Fresenius Medical Care Renal Therapies Group, LLC
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