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Recall Observatory FDA recall evidence

Device product

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Z-0813-2021

November 07, 2020

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 86855
Status
Ongoing
Classification
Class II
Quantity
5765 cases
Official record key
device-enforcement:Z-0813-2021

Official wording

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

Code information: Lot Numbers: 20LXAC061 20NXAC036 20LXAC062 Additional affected lots as of 3/17/21: 20LXAC099 20LXAC086 20NXAC014

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.