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Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000 Series

by Fresenius Medical Care North America

510(k) K070177

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

31 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK070177 Date29 Mar 2007ClearedStatusActive

Recalls

35 recalls · 31 ongoing · FDA

    • Ongoing Z-0181-2023 FDA Class II initiated 4 Oct 2022

    The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.

  • 11 recalls, same reason

    • Ongoing Z-0837-2021 FDA Class II initiated 23 Nov 2020
    • Ongoing Z-0834-2021 FDA Class II initiated 23 Nov 2020
    • Ongoing Z-0835-2021 FDA Class II initiated 23 Nov 2020
    • Ongoing Z-0832-2021 FDA Class II initiated 23 Nov 2020
    • Ongoing Z-0833-2021 FDA Class II initiated 23 Nov 2020
    • Ongoing Z-0831-2021 FDA Class II initiated 23 Nov 2020
    • Ongoing Z-0839-2021 FDA Class II initiated 23 Nov 2020
    • Ongoing Z-0840-2021 FDA Class II initiated 23 Nov 2020
    • Ongoing Z-0836-2021 FDA Class II initiated 23 Nov 2020
    • Ongoing Z-0838-2021 FDA Class II initiated 23 Nov 2020
    • Ongoing Z-0841-2021 FDA Class II initiated 23 Nov 2020

    The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.

  • 19 recalls, same reason

    • Ongoing Z-0815-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0814-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0821-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0826-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0822-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0829-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0816-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0819-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0820-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0818-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0825-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0811-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0813-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0823-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0817-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0812-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0827-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0824-2021 FDA Class II initiated 7 Nov 2020
    • Ongoing Z-0828-2021 FDA Class II initiated 7 Nov 2020

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

    • Terminated Z-0942-2021 FDA Class II initiated 17 Dec 2020

    Bottles Missing Product Label

    • Terminated Z-2110-2018 FDA Class II initiated 2 May 2018

    The bottles are mislabeled with an incorrect part number.

    • Terminated Z-1010-2018 FDA Class II initiated 29 Sep 2017

    The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.

    • Terminated Z-0887-2016 FDA Class II initiated 18 Jan 2016

    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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KPO
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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