Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Recall
- Recall Number
- Z-0992-2026
- Event Number
- 97989
- Firm
- Diasol, Inc
- FEI Number
- 3007137482
- Product Code
- KPO
- Status
- Open, Classified
- Root Cause
- Process design
- Initiated
- November 5, 2025
- Posted
- December 23, 2025
- Address
- 310 S 43rd Ave, Ste B, Phoenix, AZ, 85009-4606
Description
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Safety and efficacy of dialysis acid concentrate cannot be assured
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.
US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
2200 gallons