Fresenius Medical Care Holdings, Inc. Recall 87998
Description: Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
Fresenius Medical Care Holdings, Inc. Recall 87998 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2086-2021 |
| Event ID | 87998 |
| Event Description | Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis. |
| Product Type | Devices |
| Distribution | US Distribution to: TX only |
| Quantity | (1) 1 case (2) 4 cases (3) 5 cases |
| Recall Reason | Exposed to freezing temperatures due to refrigerated truck malfunctions |
| Device Classification | 20210728 |
| Device Code Info | Lot Number/UDI: (1)21BTAC004 UDI: (01)00840861101535 (2)21AGAC026 UDI: (01)00840861101696 (3)21BTAC008 UDI: (01)00840861101740 |
| Center Classification Date | 20210716 |
| Recall Initiation Date | 20210428 |
| Recalling Firm | Fresenius Medical Care Holdings, Inc. |
| Initial Notification | Telephone |
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