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Recall Observatory FDA recall evidence

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

April 28, 2021

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
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

    reason.no_named_rule · v1.0.0

    Exposed to freezing temperatures due to refrigerated truck malfunctions