Summary Company Announcement Date: April 29, 2022 FDA Publish Date: May 02, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential contamination with Burkholderia gladioli Company Name: Fagron Inc. Brand Name: Brand Name(s) Product Description: Product Description SyrSpend SF 500mL and 4L Company Announcement FOR IMMEDIATE RELEASE – 04/29/2022 – St. Paul, Minnesota,…
Philips Respironics Issues Voluntary Recall Notification/Field Safety Notice* for the V60 Ventilator Product Family
Summary Company Announcement Date: April 22, 2022 FDA Publish Date: May 02, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description A potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm Company Name: Philips Respironics Brand Name: Brand Name(s) Philips Respironics Product…
Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, Non-CLIA-Certified Users
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Celltrion DiaTrust COVID-19 Ag Rapid Test Product Codes: 83QKP Lot Numbers: See recall database entry Distribution Dates: December 2021 to February 2022 Devices Recalled in…
Potential for Internal Pump Malfunction in the Medtronic HVAD System – Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting health care providers to the possibility that patients who have the Medtronic Heartware Ventricular Assist Device (HVAD) System and appear to present with pump thrombosis may have a welding defect in the internal pump causing the pump to malfunction. This week, Medtronic issued an Urgent Medical…
Potential Risk of Airway Obstruction When Using Certain Electromyogram Endotracheal Tubes – Letter to Health Care Providers
April 27, 2022 The U.S. Food and Drug Administration (FDA) is evaluating the potential risk of airway obstruction when using silicone-based electromyogram (EMG) endotracheal tubes (Medtronic NIM Standard Reinforced EMG Endotracheal Tube and Medtronic NIM Contact Reinforced EMG Endotracheal Tube). The FDA has received reports describing serious adverse events and deaths for these devices after…
FDA D.I.S.C.O. Burst Edition: FDA approval of Vijoice (alpelisib) for adult and pediatric patients two years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum who require systemic therapy
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide another quick update on a recent FDA cancer drug approval. On April 5, 2022, the FDA granted accelerated approval to…
Medtronic Recalls Harmony Delivery Catheter, Part of Transcatheter Pulmonary Valve (TPV) System, for Risk of Capsule Break During Use
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Harmony Delivery Catheter System Product Codes and Batch Numbers: See database entry. Distribution Dates: April 7, 2021 to January 26, 2022 Devices Recalled in the…
Pfizer Voluntary Nationwide Recall of Lots of ACCUPRIL® (Quinapril HCl) Due to N-Nitroso-Quinapril Content
Summary Company Announcement Date: April 22, 2022 FDA Publish Date: April 22, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to N-Nitroso-Quinapril Content Company Name: Pfizer Brand Name: Brand Name(s) Product Description: Product Description Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg Company Announcement FOR IMMEDIATE RELEASE – NEW YORK, NY., April…
FDA D.I.S.C.O. Burst Edition: FDA approval Yescarta (axicabtagene ciloleucel) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer therapeutic approval. On April 1, 2022, the FDA approved axicabtagene ciloleucel (brand…
Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication
Discuss the results of genetic prenatal screening tests with a genetic counselor or other health care provider. Date Issued: April 19, 2022 The U.S. Food and Drug Administration (FDA) is warning patients and health care providers about the risks of false results with genetic non-invasive prenatal screening (NIPS) tests, sometimes called noninvasive prenatal testing or…