Recall Z-1370-2022 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care Holdings, Inc.
NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0
| Date | May 31, 2022 |
| Status | Open, Classified |
| Reason | Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use |
| Root cause | Under Investigation by firm |
| Action | Fresenius Medical Care issued Urgent Medical Device Recall letter (FA-2022-11-T) dated 6/2/22. Letter states reason for recall, health risk and action to take: These instructions apply only to clinics directly contacted by the Fresenius Medical Care Corrections and Removals Department. " Immediately examine your stock to determine whether you have NaturaLyte Liquid Acid concentrate with the part and lot numbers listed below. " Only bottles with sealed for your protection on the bottle cap foil are affected (see picture below). " Remove the affected product from your inventory. " FMCRTG, LLC |
| Quantity | 656 cases |
| Distribution | Natiowide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate Fresenius Medical Care Renal Therapies Group, LLC, Apr 24, 2020 |