Recall Z-0181-2023 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
| Date | Nov 4, 2022 (initiated Oct 4, 2022) |
| Status | Open, Classified |
| Reason | The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free. |
| Root cause | Error in labeling |
| Action | On October 4, 2022, the firm notified affected customers via Important Medical Device Information letters. Customers were reassured that the product was manufactured according to specification and remains potassium-free. Customers may continue to use the product. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have further questions. |
| Quantity | 17700 |
| Distribution | Domestic distribution to AL AZ CA DC FL GA HI IL IN MD MI MO MS NE NJ NY OH PA SD TX VA No foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070177 | FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES Fresenius Medical Care North America, Mar 29, 2007 |