Drugs & medicalClass II

Fresenius Medical Care Holdings, Inc. recalls NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for…

Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

Read the official notice →
Date
2022-07-20
Country
United States
Brand
Fresenius Medical Care Holdings
Product
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic…
Classification
Class II
Units
Natiowide
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Fresenius Medical Care Holdings recalls

  1. 2022-10-26
  2. US
    Drugs & medicalClass II

    Fresenius Medical Care Holdings, Inc. recalls 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs,…

    Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

    FDA · DrugFresenius Medical Care Holdings, Inc.Nationwide in the USAOfficial notice →
  3. 2022-09-28
  4. US
    Drugs & medicalClass II

    Fresenius Medical Care Holdings, Inc. recalls AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius…

    Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured

    FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV,…Official notice →
  5. 2022-08-03
  6. US
    Drugs & medicalClass II

    Fresenius Medical Care Holdings, Inc. recalls AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US

    Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on…

    FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution.Official notice →
  7. 2022-07-20
  8. US
    Drugs & medicalClass II

    Fresenius Medical Care Holdings, Inc. recalls AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ…

    AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device.…

    FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of NC and WV.Official notice →
  9. 2022-07-13
  10. US
    Drugs & medicalClass II

    Fresenius Medical Care Holdings, Inc. recalls NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3

    The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream…

    FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of Texas and Louisiana.Official notice →
  11. 2022-07-06
  12. US
    Drugs & medicalClass II

    Fresenius Medical Care Holdings, Inc. recalls Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E

    Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.

    FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the state of Pennsylvania.Official notice →
All 33 Fresenius Medical Care Holdings recalls →

Other drugs & medical recalls in the United States

  1. 2022-07-20
  2. US
    Drugs & medicalClass II

    Ventana Medical Systems Inc recalls Ventana HE 600 System, automated slide preparer, for use in laboratories.

    There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire

    FDA · DeviceVentana Medical Systems IncUS: AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD MI MN MO MS MT NC NE NJ…Official notice →
  3. US
    Drugs & medicalClass II

    Alcon Research, LLC recalls Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL…

    Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.

    FDA · DeviceAlcon Research, LLCU.S.: AZ, CA, MO, and NY O.U.S.: NoneOfficial notice →
  4. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics Inc recalls epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or…

    Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.

    FDA · DeviceSiemens Healthcare Diagnostics IncAL CA CO FL IA ID KS NM OK TXOfficial notice →
  5. US
    Drugs & medicalClass III

    Invacare Corporation recalls Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)

    Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.

    FDA · DeviceInvacare CorporationDomestic distribution to the following states: ALASKA ARIZONA CALIFORNIA…Official notice →
  6. US
    Drugs & medicalClass II

    Ultradent Products, Inc. recalls Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill,…

    SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.

    FDA · DeviceUltradent Products, Inc.Worldwide distribution - US Nationwide distribution in the states of Florida,…Official notice →
  7. US
    Drugs & medicalClass II

    Ortho-Clinical Diagnostics, Inc. recalls Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿…

    On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).

    FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Colombia, India,…Official notice →
See all drugs & medical recalls →