CLASS II ONGOING Device recall · Reported 30 Oct 2024 · FDA Enforcement Report
Acid Concentrate recalled by Diasol
Diasol is recalling Acid Concentrate, distributed nationwide in the US. The recall was initiated on 27 Jul 2022 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-0207-2025
- FDA event ID
- 95334
- Recalling firm
- Diasol, Phoenix, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Jul 2022
- FDA classified
- 23 Oct 2024
- Reported
- 30 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 27 Jul 2022 | Recall initiated by company | |
| 23 Oct 2024 | Classified by FDA | +819 days |
| 30 Oct 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Diasol Acid Concentrate REF G100325-10Dex 100
Where it was distributed
U.S. Nationwide distribution in the state of AZ.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Catalog Number: G100325-10Dex100 UDI code: B467100325101004 Lot Number:PHS06011/061722
Where was it sold?
U.S. Nationwide distribution in the state of AZ.
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 |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |