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Recall Observatory FDA recall evidence

Device product

Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Z-0828-2021

November 07, 2020

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 86855
Status
Ongoing
Classification
Class II
Quantity
198 drums
Official record key
device-enforcement:Z-0828-2021

Official wording

Reason: The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Code information: Lot Numbers: 20LXAC031 Additional affected lots as of 3/17/21: 20NXAC004 20LXAC033 20NXAC003 20LXAC032

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.