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HSAG ESRD Alerts, Recalls, and Notices

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  • Abbott (formally known as “St. Jude Medical”) Recalls Assurity™ and Endurity™ Pacemakers for Potential Moisture Ingress Causing Electrical Short and Reduced Battery Life

    Friday, May 14, 2021
    Abbott (formally known as “St. Jude Medical”) is recalling a subset of Assurity and Endurity pacemakers built using specific manufacturing equipment, that were then distributed from April 2015 to February 2019. A small number of devices from that time frame have experienced problems...

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  • Magnets in Cell Phones and Smart Watches May Affect Pacemakers and Other Implanted Medical Devices

    Friday, May 14, 2021
    Some consumer electronic devices, such as certain cell phones and smart watches, include high field strength magnets. Recent studies have shown that consumer electronic devices with high field strength magnets may cause certain implanted medical devices to switch to “magnet mode” and...

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  • Novo Nordisk Issues Voluntary Nationwide Recall of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® Product Samples Due to Improper Storage Temperature Conditions

    Wednesday, May 12, 2021
    Novo Nordisk is voluntarily recalling 1,468 product samples listed in the table below of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy®, to the consumer level. These products are being recalled because they were stored at temperatures below storage requirements. This recall...

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  • Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic

    Wednesday, May 12, 2021
    Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15...

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  • Medtronic, Inc. Recalls Instructions for Use and Patient Manual for HeartWare HVAD System to Update Information about Carrying Case, Driveline Cover, and Controller Power-Up Issues

    Wednesday, May 12, 2021
    Medtronic is recalling their HeartWare HVAD System to provide updated Instructions for Use (IFU) and Patient Manual (PM) due to safety issues with (1) Carrying Cases, (2) Driveline Cover Orientation and; (3) Controller Power-Up Sequence.

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  • Hospira Issues A Voluntary Nationwide Recall for One Lot of Sterile Water for Injection, USP, Due to the Potential Presence of Visible Particulate

    Friday, May 7, 2021
    Hospira, Inc., a Pfizer company, is voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, to the hospital/institution level due to a confirmed customer report for a single vial with a visible particulate.

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  • Hospira Issues A Voluntary Nationwide Recall for One Lot of 0.5% Bupivacaine Hydrochloride Injection, USP and One Lot of 1% Lidocaine HCl Injection, USP Due to Mislabeling

    Wednesday, May 5, 2021
    Hospira, Inc., a Pfizer company, is voluntarily recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCl Injection, USP 30 mL, to the hospital/institution level due to mislabeling whereby a portion of each lot was incorrectly labeled as the...

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  • Hospira Issues A Voluntary Nationwide Recall for One Lot of Sterile Water for Injection, USP, Due to the Potential Presence of Visible Particulate

    Wednesday, May 5, 2021
    Hospira, Inc., a Pfizer company, is voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, to the hospital/institution level due to a confirmed customer report for a single vial with a visible particulate.

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  • Acella Pharmaceuticals, LLC, Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Sub Potency

    Wednesday, May 5, 2021
    Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots listed in the Tables 1 and 2 below of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because routine...

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  • Pacific Medical Group (DBA Avante Health Solutions) Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts

    Tuesday, May 4, 2021
    Pacific Medical Group (DBA Avante Health Solutions) is recalling the affected products and devices because the front bezel components may crack or separate, leading to inaccurate delivery of fluids to patients. The separation of one or more bezel posts may result in: free flow of fluids to...

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