Recall Z-0837-2021 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
| Date | Jan 11, 2021 (initiated Nov 23, 2020) |
| Status | Open, Classified |
| Reason | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Recall notification letter dated 11/23/20 was sent to customers. Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) previously issued Urgent Medical Device Alerts on November 7, 2020 and November 14, 2020 alerting you to issues pertaining to the sodium level in the Naturalyte Liquid Acid concentrate and Citrasate Liquid Acid concentrate products impacting 105 lots, manufactured at the Oregon, Ohio facility between September 9, 2020 and October 29, 2020. After further testing, FMCRTG is now voluntarily recalling 28 of the 105 lots for one or both of the followi |
| Quantity | 5079 cases |
| Distribution | US Nationwide 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 |