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Recall Observatory FDA recall evidence

Device product

NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is 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-2087-2021

April 28, 2021

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 87998
Status
Terminated
Classification
Class II
Quantity
120 Bags
Official record key
device-enforcement:Z-2087-2021

Official wording

Reason: Exposed to freezing temperatures due to refrigerated truck malfunctions

Code information: Lot Number: 21ATBC004 UDI: (01)00840861101955

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