Device product
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.
Z-2086-2021
Product summary
- Event
- Event 87998
- Status
- Terminated
- Classification
- Class II
- Quantity
- (1) 1 case (2) 4 cases (3) 5 cases
- Official record key
device-enforcement:Z-2086-2021
Official wording
Reason: Exposed to freezing temperatures due to refrigerated truck malfunctions
Code information: Lot Number/UDI: (1)21BTAC004 UDI: (01)00840861101535 (2)21AGAC026 UDI: (01)00840861101696 (3)21BTAC008 UDI: (01)00840861101740
Distribution pattern: US Distribution to: TX only
Derived failure modes
-
Unknown
Exposed to freezing temperatures due to refrigerated truck malfunctions