Recall Z-0207-2025 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Diasol, Inc
Diasol Acid Concentrate REF G100325-10Dex 100
| Date | Oct 23, 2024 (initiated Jul 27, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Labeling mix-ups |
| Action | On 07/26/2022, the firm communicated via email with customer that 2 case were incorrectly labeled. Cases marked 3K 2.5ca have inside box label as 3K 2.0ca. Customer was instructed not to use the product and the firm picked up mislabeled product. |
| Quantity | 852 gallon bottles |
| Distribution | U.S. Nationwide distribution in the state of AZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851431 | HEMODIALYSIS CONCENTRATE ADDITIVES Dana Laboratories, Jun 12, 1985 |