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U.S. Department of Health and Human Services

Class 2 Device Recall Bicarby Dialysate

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 Class 2 Device Recall Bicarby Dialysatesee related information
Date Initiated by FirmMay 07, 2026
Date PostedJune 11, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2401-2026
Recall Event ID 98892
510(K)NumberK243786 
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
ProductBicarby Dialysate; Model number: RFP-400-G;
Code Information Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;
FEI Number 3001451489
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 920
Waltham MA 02451-1521
For Additional Information ContactFresenius Customer Service Team
800-323-5188
Manufacturer Reason
for Recall		There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
FDA Determined
Cause 2		Process control
ActionOn 5/7/2026 an URGENT MEDICAL DEVICE RECALL letters were sent to customers. At this time, FMCRTG is providing this recall notice to alert you of the potential risks associated with the labeling error, and to ask that you identify, segregate, and discontinue use of affected lots, 25SG06026 and 25SG06027, of RFP-400-G Bicarby Dialysate. FMCRTG is requiring the return of the affected Bicarby Dialysate lots. FMCRTG will replace all remaining stock of affected product lots. For product technical questions or concerns, please contact Technical Support at 1-800-323-2732 or Customer Support at 1-800-323-5188 between 8:30AM 4:30PM Eastern Daylight Time. For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.
Quantity in Commerce4752
DistributionDomestic: TX.
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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