Skip to content
Recall Observatory FDA recall evidence

Device product

Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis

Z-0887-2016

January 18, 2016

Class II

Product summary

Firm
Fresenius Medical Care Renal Therapies Group, LLC
Event
Event 73077
Status
Terminated
Classification
Class II
Quantity
848 (212 cases)
Official record key
device-enforcement:Z-0887-2016

Official wording

Reason: On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.

Code information: Lot Number: 15STAC072 Exp Date: 2017-12-31

Distribution pattern: US Distribution to states of: KS, LA, MS, OK, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.