Fresenius Medical Care Holdings, Inc. Recall 86855
Description: NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Fresenius Medical Care Holdings, Inc. Recall 86855 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0823-2021 |
| Event ID | 86855 |
| Event Description | NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 51 drums |
| Recall Reason | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. |
| Device Classification | 20210120 |
| Device Code Info | Lot Numbers: 20LXAC034 20LXAC069 20NXAC040 |
| Center Classification Date | 20210111 |
| Recall Initiation Date | 20201107 |
| Recalling Firm | Fresenius Medical Care Holdings, Inc. |
| Initial Notification | Letter |
| Similar To |