CLASS II Device recall · Reported 24 Jun 2020 · FDA Enforcement Report
1000225-10-dex100 Liquid Acid Concentrate For Bicarbonate Dialysis recalled
Diasol is recalling 1000225-10-dex100 Liquid Acid Concentrate For Bicarbonate Dialysis, distributed in California. The recall was initiated on 30 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2402-2020
- FDA event ID
- 85695
- Recalling firm
- Diasol, Phoenix, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2020
- FDA classified
- 18 Jun 2020
- Reported
- 24 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 30 Apr 2020 | Recall initiated by company | |
| 18 Jun 2020 | Classified by FDA | +49 days |
| 24 Jun 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect labeling of dialysate concentration for hemodialysis.
Product as listed by the FDA
DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
Where it was distributed
U.S.: CA O.U.S.:None
Questions about this recall
Why was it recalled?
Incorrect labeling of dialysate concentration for hemodialysis.
Which lots are affected?
Model Number: 100225-10-DEX100 Gallons Unique Device Identifier (UDI): B467100225101004 and B4671000225101004 Lot codes if applicable: PHQ03041/030920
Where was it sold?
U.S.: CA O.U.S.:None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Diasol
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 100230-10-DEX100, Liquid Concentrate recalled by Diasol | Diasol | Other | Nationwide |
| Device | CLASS II | 100125-10-DEX100, Liquid Concentrate recalled by Diasol | Diasol | Other | Nationwide |
| Device | CLASS II | 100325-10-DEX100, Liquid Concentrate recalled by Diasol | Diasol | Other | Nationwide |
| Device | CLASS II | 100220-10-DEX100, Liquid Concentrate recalled by Diasol | Diasol | Other | Nationwide |
| Device | CLASS II | 100225-10-DEX100, Liquid Concentrate recalled by Diasol | Diasol | Other | Nationwide |
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