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.…

Read the official notice →
Date
2022-07-20
Country
United States
Brand
Fresenius Medical Care Holdings
Product
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA…
Classification
Class II
Units
US Nationwide distribution in the states of NC and WV.
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2022-09-28
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    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

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  3. 2022-08-03
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    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…

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  5. 2022-07-20
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    Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

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  7. 2022-07-13
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    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 →
  9. 2022-07-06
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    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 →
  11. 2022-02-16
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    Fresenius Medical Care Holdings, Inc. recalls Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours)…

    Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted…

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All 33 Fresenius Medical Care Holdings recalls →

Other drugs & medical recalls in the United States

  1. 2022-07-20
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    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 →
  3. US
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    Wright Medical Technology, Inc. recalls Wright EVOLVE TRIAD Plate Cutter, REF 49510120

    The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use

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    The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.

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    Potential for stent dislodgement and associated failures related to two specific sizes of the device.

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    Cook Incorporated recalls Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

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