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April 2021

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  • FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review

    Monday, April 26, 2021
    Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson &...

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  • BD Announces the Voluntary Recall of Specified Lots of ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator in the United States and U.S. Territories Due to Defective Applicator

    Thursday, April 22, 2021
    BD (Becton, Dickinson and Company), a leading global medical technology company, is voluntarily recalling specified lots of the ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator (2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) to the user level due to a defective...

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  • Medtronic Perfusion Systems Recalls Bio-Console 560 Extracorporeal Blood Pumping Console for Possible Electrical Failure Causing the Pump to Stop

    Tuesday, April 20, 2021
    Medtronic is recalling the Bio-Console 560 Extracorporeal Blood Pumping Console due to reports of electrical failure causing the device to stop. Other issues observed by users include the interface going blank, smoke coming from the device and a burning odor during use.

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  • Tenacore Recalls Alaris Pump Bezel Assembly and Alaris Infusion Pumps repaired with Bezel Assembly Due to Possible Cracked or Separated Bezel Repair Posts

    Monday, April 19, 2021
    Tenacore is recalling the Alaris Pump because the bezel repair posts may crack or separate leading to inaccurate delivery of fluids to patients. The separation of one or more bezel repair posts may result in: free flow of fluids to patient over delivery or under delivery of fluids delivered to a...

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  • Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab

    Monday, April 19, 2021
    Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients....

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  • CareFusion 303, Inc. Recalls BD Alaris Pump Module Model 8100 Due to Risk of Stuck or Unresponsive Keys

    Friday, April 16, 2021
    CareFusion 303 Inc is recalling the Alaris Pump Module because of the risk of the keypad lifting up due to fluid entry. This could lead to keys that become unresponsive or stuck (See Figure 1). This may lead to an infusion delay or interruption or prevent clinicians from changing fluid or...

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  • Medtronic Recalls HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Due to Risk of Damage to Controller Ports

    Friday, April 16, 2021
    Medtronic is recalling the HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports because of risk of wear and tear of the connector plugs (power sources, data cable, and alarm adapter) which could cause damage to the Controller port metal pins (for example, bent pins).

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  • Janssen COVID-19 Vaccine Frequently Asked Questions

    Thursday, April 15, 2021
    On February 27, 2021, 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 Janssen COVID-19 Vaccine to...

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  • Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Receipt of the Johnson & Johnson COVID-19 Vaccine

    Wednesday, April 14, 2021
    As of April 12, 2021, approximately 6.85 million doses of the Johnson & Johnson (J&J) COVID-19 vaccine (Janssen) have been administered in the United States. The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are reviewing data involving six...

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  • Smisson-Cartledge Biomedical, LLC Recalls ThermaCor 1200 Disposable Sets for Risk of Patient Contact to Aluminum

    Tuesday, April 13, 2021
    Smisson-Cartledge Biomedical is recalling their ThermaCor 1200 Rapid Thermal Infusion System Disposable Sets because a part of the ThermaCor 1200 Disposable Set, the cassette (See Figure 1), which warms fluids directly with an aluminum plate may leak aluminum into the fluids and expose patients to...

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