Class 2 Device Recall Diasol Acid Concentrate

• Date Initiated by Firm: July 27, 2022
• Date Posted: October 23, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0207-2025
• Recall Event ID: 95334
• 510(K)Number: K851431
• Product Classification: Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
• Product: Diasol Acid Concentrate REF G100325-10Dex 100
• Code Information: Catalog Number: G100325-10Dex100 UDI code: B467100325101004 Lot Number:PHS06011/061722
• Recalling Firm/ Manufacturer: Diasol, Inc; 310 S 43rd Ave Ste B; Phoenix AZ 85009-4606
• For Additional Information Contact: Monica Abeles; 602-442-7640
• Manufacturer Reason for Recall: Due to labeling issue. The box label is different that the gallon label in that gallon label shows a lower Calcium concentration than the box label.
• FDA Determined Cause: Labeling mix-ups
• Action: On 07/26/2022, the firm communicated via email with customer that 2 case were incorrectly labeled. Cases marked 3K 2.5ca have inside box label as 3K 2.0ca. Customer was instructed not to use the product and the firm picked up mislabeled product.
• Quantity in Commerce: 852 gallon bottles
• Distribution: U.S. Nationwide distribution in the state of AZ.
• 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