Drugs & medicalClass II

Baxter Healthcare Corporation recalls Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to…

There is a potential for foreign matter.

Read the official notice →
Date
2022-05-11
Country
United States
Brand
Baxter Healthcare
Product
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide…
Classification
Class II
Units
Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Baxter Healthcare recalls

  1. 2022-06-08
  2. US
    Drugs & medicalClass II

    Baxter Healthcare Corporation recalls 3,65 m Extension Set with Luer-lock Connector

    Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

    FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.Official notice →
  3. US
    Drugs & medicalClass I

    Baxter Healthcare Corporation recalls In-Line ventilator adaptor

    There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.

    FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL,…Official notice →
  4. 2022-05-25
  5. US
    Drugs & medicalClass II

    Baxter Healthcare Corporation recalls Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and…

    Firm discovered a firmware memory leak with a supplier-manufactured component.

    FDA · DeviceBaxter Healthcare CorporationUS Distribution to states of: NC and VA.Official notice →
  6. 2022-05-04
  7. US
    Drugs & medicalClass II

    Baxter Healthcare Corporation recalls PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701

    This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit…

    FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Mexico, Brazil,…Official notice →
  8. 2022-04-27
  9. US
    Drugs & medicalClass II

    Baxter Healthcare Corporation recalls Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.

    Product is mislabeled as self-righting Luer slip tip caps, yellow.

    FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide distribution in the states of FL, GA,…Official notice →
  10. 2022-04-06
  11. US
    Drugs & medicalClass II

    Baxter Healthcare Corporation recalls MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484

    Devices distributed lacked regulatory clearance.

    FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of California, Colorado, District of…Official notice →
All 123 Baxter Healthcare recalls →

Other drugs & medical recalls in the United States

  1. 2022-05-11
  2. US
    Drugs & medicalClass II

    restor3d Inc. recalls Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument

    During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.

    FDA · Devicerestor3d Inc.US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.Official notice →
  3. US
    Drugs & medicalClass II

    restor3d Inc. recalls Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual…

    Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.

    FDA · Devicerestor3d Inc.US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.Official notice →
  4. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN:…

    Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice →
  5. US
    Drugs & medicalClass II

    Becton Dickinson & Co. recalls BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10

    When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.

    FDA · DeviceBecton Dickinson & Co.Worldwide distribution US Nationwide distribution in the states of CA, IL, MI,…Official notice →
  6. US
    Drugs & medicalClass I

    SML Distribution, LLC recalls Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

    The product was distributed without FDA authorization or clearance for marketing and distribution in the US.

    FDA · DeviceSML Distribution, LLCUS Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.Official notice →
  7. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion systems with software release R1.x

    In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.US Nationwide and Worldwide DistributionOfficial notice →
See all drugs & medical recalls →