Skip to main content

HSAG ESRD Alerts, Recalls, and Notices

Diverse Support Group Inside Hospital with Busy Nurses
Top
  • Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL Due to Potential Lack of Sterility Assurance

    Monday, March 15, 2021
    Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL). This product was manufactured by Indoco Remedies Ltd. and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of...

    Read More
  • Combat Medical Systems, LLC, Recalls Valkyrie LTOWB Collection, Valkyrie LTOWB Administration, Low Titer Type O FWB Transfusion Set, Fresh Whole Blood Transfusion Set, Fresh Whole Blood Donor Set for Possible Broken or Bent Needles

    Monday, March 15, 2021
    Combat Medical is recalling the convenience kits because the needle in the blood pack may bend or disconnect from the blood bag. The possible needle damage only occurs during the packaging process before being received by the user. However, a user will not be able to identify if the needle is...

    Read More
  • Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Spironolactone 25 mg and 50 mg Tablets Due to Mislabeling with the Incorrect Strength

    Wednesday, March 10, 2021
    Bryant Ranch Prepack is voluntarily recalling 4 lots of Spironolactone tablets to the consumer level. The products have been found to be mislabeled, displaying the incorrect strength. Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets and prepackaged bottles...

    Read More
  • Why You Should Not Use Ivermectin to Treat or Prevent COVID-19

    Monday, March 8, 2021
    COVID-19. We’ve been living with it for what sometimes seems like forever. Given the number of deaths that have occurred from the disease, it’s perhaps not surprising that some consumers are looking at unconventional treatments, not approved or authorized by the Food and Drug...

    Read More
  • Improper Use of Thermal Imaging Devices: FDA Safety Communication

    Monday, March 8, 2021
    The U.S. Food and Drug Administration (FDA) is alerting consumers, health care providers and other users of thermal imaging systems intended to measure human body temperature that improper use of these systems may provide inaccurate temperature readings. These devices are also known as...

    Read More
  • Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart After the Pump is Stopped

    Wednesday, March 3, 2021
    Medtronic is recalling the HVAD Pump Implant Kit because the device may fail to initially start, restart, or have a delay in restarting after the pump was stopped. These delays or failures to start or restart have occurred during preimplant testing, during the implant, or in a variety of...

    Read More
  • FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

    Monday, March 1, 2021
    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be...

    Read More
  • Boston Scientific Corporation Recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit

    Monday, February 22, 2021
    Boston Scientific is recalling the EMBLEM S-ICD because a manufacturing process may allow moisture to get inside the defibrillator and cause a short-circuit when it tries to deliver high voltage shocks. If this happens during use, patients may experience less shock than intended or may not receive...

    Read More
  • Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures

    Tuesday, February 16, 2021
    Boston Scientific is recalling the EMBLEM S-ICD Subcutaneous Electrode because of increased risk of fractures at a specific point (distal to the proximal sense ring) shown in Figure 1. If the device fractures during use, it could become unable to deliver therapy to slow very fast heartbeats from...

    Read More
  • Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error

    Thursday, February 11, 2021
    Smiths Medical is recalling specific software versions of the Medfusion 3500 and 4000 Syringe Pumps because of a software error that may lead to over-delivery or under-delivery of fluids or medication. Over- or under-delivery can occur if the following specific sequence of events occur: a bolus or...

    Read More