Device product
Citrasate Dry Acid Concentrate and GranuFlo Dry 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.
Z-2084-2021
Product summary
- Event
- Event 87998
- Status
- Terminated
- Classification
- Class II
- Quantity
- (1) 40 cases (2) 3 cases (3) 4 cases
- Official record key
device-enforcement:Z-2084-2021
Official wording
Reason: Exposed to freezing temperatures due to refrigerated truck malfunctions
Code information: Lot Number/UDI: (1) 21ATGF013 (01)00884086110135 0FD3251-3B (2) 20SXGF010 (01)00840861101597 0FD3251-3B (3) 20SXGF013 (01)00840861101597
Distribution pattern: US Distribution to: TX only
Derived failure modes
-
Unknown
Exposed to freezing temperatures due to refrigerated truck malfunctions