Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA,
FDA device recall Z-0992-2026 · posted 2025-12-23 · Open, Classified
Recall details
- Recalling firm
- Diasol, Inc
- Reason for recall
- Safety and efficacy of dialysis acid concentrate cannot be assured
- Action taken
- On November 5, 2025, Diasol issued a "Urgent Medical Device Recall Notification to affected consignees. In addition to informing consignees about the recall, Diasol asked consignees to take the following actions: 1. Please return all product you have at your facility. 2. Please complete the attached acknowledgement form. 3. If product has been further distributed to other distributors, customer or sites, notify those consignees and provide them with a copy of the recall notification. 4. The notice should be provided to all staff members who use the product. 5. In the event you have not received adequate products from Rockwell you may continue to use Diasol Products at risk.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- KPO
- Quantity affected
- 2200 gallons
- Distribution
- US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
- Date initiated
- 2025-11-05
- Date posted
- 2025-12-23
- Location
- Phoenix, AZ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMODIALYSIS CONCENTRATE ADDITIVES (K851431) | Dana Laboratories | 1985-06-12 |