Fresenius Medical Care Holdings, Inc. Recall 86939
Description: Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - 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 86939 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0832-2021 |
| Event ID | 86939 |
| Event Description | Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - 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 | 2246 cases |
| Recall 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. |
| Device Classification | 20210120 |
| Device Code Info | Lot Numbers: 20LXAC086 20LXAC099 20NXAC014 Additional Affected lots as of 3/17/21: 20LXAC061 20LXAC062 20LXAC099 20LXAC086 20NXAC014 |
| Center Classification Date | 20210111 |
| Recall Initiation Date | 20201123 |
| Recalling Firm | Fresenius Medical Care Holdings, Inc. |
| Initial Notification | Letter |
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