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U.S. Department of Health and Human Services

Class 2 Device Recall Citric Complete Dry Citric Acid Concentrate

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 Class 2 Device Recall Citric Complete Dry Citric Acid Concentratesee related information
Date Initiated by FirmNovember 22, 2024
Date PostedJanuary 08, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0820-2025
Recall Event ID 95878
510(K)NumberK171750 
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
ProductCitric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
Code Information Model Number: DCA+225-25. Lot Numbers: NDC4F001, NDC4G006, NDC4H009, NDC4H010.
Recalling Firm/
Manufacturer		 Nipro Renal Soultions USA, Corporation
509 Fishing Creek Rd
Lewisberry PA 17339-9517
For Additional Information ContactJessica Oswald-McLeod
717-938-8391
Manufacturer Reason
for Recall		The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
FDA Determined
Cause 2		Process control
ActionNipro notified their distributor on 11/22/2024 via email. Direct customers were notified via email on 11/25/2024. The firm sent a "Medical Device Recall" letter dated 11/11/2024 to its customers. The letter instructed customers to place any affected units in inventory on hold and return them immediately. They were also instructed to complete the quantity in stock column on the attached response form and return to USorders@nipromed.com for processing. Nipro Partner Solutions team will coordinate the return of all recalled products from your facility back to Nipro. If you have any questions, contact Director QA/RA at 717-938-8391.
Quantity in Commerce2,810 units
DistributionUS distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, 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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