Drugs & medicalClass II

Iradimed Corporation recalls Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,

Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which…

Read the official notice →
Date
2023-04-05
Country
United States
Brand
Iradimed Corporation
Product
Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
Classification
Class II
Units
Worldwide distribution - US Nationwide and the countries of Austria, Canada,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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.

Other drugs & medical recalls in the United States

  1. 2023-04-05
  2. US
    Drugs & medicalClass II

    Fujifilm Irvine Scientific, Inc. recalls Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305

    Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.

    FDA · DeviceFujifilm Irvine Scientific, Inc.U.S.: AZ, AR, CA, CT, DC, FL, HI, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO,…Official notice →
  3. US
    Drugs & medicalClass II

    Defibtech, LLC recalls DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest

    A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.

    FDA · DeviceDefibtech, LLCUS Nationwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material #…

    In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution.Official notice →
  5. US
    Drugs & medicalClass II

    Elekta Instrument AB recalls Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund…

    The incorrect IFU was distributed with the devices.

    FDA · DeviceElekta Instrument ABUS Nationwide distribution in the states of AZ, CA, CO, FL, GA, ID, IL, KS,…Official notice →
  6. US
    Drugs & medicalClass II

    Quidel Corporation recalls MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037,…

    Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.

    FDA · DeviceQuidel Corporationnot yet availableOfficial notice →
  7. US
    Drugs & medicalClass II

    Instrumentation Laboratory recalls ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or…

    Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments

    FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide and the countries of Canada, Albania,…Official notice →
See all drugs & medical recalls →