Recall Z-3134-2026 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Nipro Renal Soultions USA, Corporation
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
| Date | Sep 10, 2026 (initiated Aug 5, 2026) |
| Status | Open, Classified |
| Reason | Hemodialysis concentrates contain high endotoxin levels |
| Root cause | Process control |
| Action | On August 6, 2026 Nipro Medical Corporation issued a Urgent Medical Device Recall notification via Email. Nipro asked consignees to take the following actions: 1. Immediately examine your inventory for the affected product codes and lot numbers listed on the Recall response form. 2. Immediately segregate, quarantine, and discontinue use or distribution of any affected product in your possession. 3. Do not use, sell, transfer, or distribute affected products. 4. Complete the enclosed Recall Response Form within 10 business days, even if you do not have affected product on hand. 5. Contact Nip |
| Quantity | 2,327 cases |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131202 | MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X Dialysis Medical Solutions, LLC, Apr 3, 2014 |