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U.S. Department of Health and Human Services

Class 2 Device Recall Diasol Acid Concentrate

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 Class 2 Device Recall Diasol Acid Concentratesee related information
Date Initiated by FirmApril 30, 2020
Create DateJune 18, 2020
Recall Status1 Terminated 3 on May 28, 2024
Recall NumberZ-2402-2020
Recall Event ID 85695
510(K)NumberK851431 
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
ProductDIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
Code Information Model Number: 100225-10-DEX100 Gallons Unique Device Identifier (UDI): B467100225101004 and B4671000225101004 Lot codes if applicable: PHQ03041/030920 
Recalling Firm/
Manufacturer		 Diasol, Inc
310 S 43rd Ave Ste B
Phoenix AZ 85009-4606
For Additional Information ContactMonica Abeles
602-442-7670
Manufacturer Reason
for Recall		Incorrect labeling of dialysate concentration for hemodialysis.
FDA Determined
Cause 2		Labeling design
ActionOn 04/30/2020, the firm called customers informing them of the labeling error and instructed customers to: -Check if they have any remaining stock -Discontinue use of the specific lot -See if there have been any adverse events if used On 05/01/2020 the firm sent an "URGENT: MEDICAL DEVICE RECALL" to customers via certified mail informing them of the above and to contact customer service at (602) 442-7670 to arrange pickup of any stock of this lot number and replacement of a different lot number will be provided. For questions, contact Customer Service at (602) 442-7670.
Quantity in Commerce212 Cases of 4 gallons each
DistributionU.S.: CA O.U.S.:None
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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