Recall Z-0991-2026 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Diasol, Inc
Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
| Date | Dec 23, 2025 (initiated Nov 5, 2025) |
| Status | Open, Classified |
| Reason | Safety and efficacy of dialysis acid concentrate cannot be assured |
| Root cause | Process design |
| Action | 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 rec |
| Quantity | 74,400 gallons |
| Distribution | US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851431 | HEMODIALYSIS CONCENTRATE ADDITIVES Dana Laboratories, Jun 12, 1985 |