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 Names: Arrow AutoCAT 2, AutoCAT 2 Refurbished, AeroautoCAT 2, AutoCAT 2 Wave, AutoCAT 2 Wave refurbished, AeroautoCAT 2 Wave, AeroautoCAT 2 Wave refurbished, AC3 NA/EMEA, AC3…
Teleflex and Arrow International, LLC Recall Arrow MAC Two-Lumen Central Venous Access and Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter (CVC) Kits
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: Arrow MAC Two-Lumen Central Venous Access Kits; Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter (CVC) Kits Product Models: See Recall Database entry…
FDA D.I.S.C.O. Burst Edition: FDA approval of Adcetris (brentuximab vedotin) in combination with chemotherapy for pediatric patients with classical Hodgkin lymphoma
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 drug approval. On November 10, 2022, the FDA approved brentuximab vedotin brand…
Actualización de los sistemas endovasculares de injerto de AAA Endologix AFX y el riesgo de endofuga de tipo III: Comunicado de seguridad de la FDA
English Fecha de emisión: 6 de diciembre de 2022 La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) está actualizando nuestro comunicado de seguridad de enero de 2022 (en inglés) sobre el uso de los injertos endovasculares Endologix AFX utilizados para tratar a pacientes con aneurisma aórtico abdominal…
Voluntary Recall of Three Detect Covid-19 Test Lots
Summary Company Announcement Date: December 08, 2022 FDA Publish Date: December 12, 2022 Product Type: Medical Devices Laboratory Tests Reason for Announcement: Recall Reason Description There is an increased chance that the tests from the lot numbers listed below may give false negative results Company Name: Detect, Inc. Brand Name: Brand Name(s) Product Description: Product…
Remel, Inc Recalls Thermo Scientific Gram Negative IVD AST Sensititre Plate for risk of potential false susceptible results
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: Thermo Scientific Gram Negative IVD AST Sensititre Plate Catalog Number: GN2F, GN3F, GN4F, GN6F, GN7F, HPB1, ESB1F, CMC5VGNF, CMC7AFLF, MDRGN3F, STP6F, STP7F Lot Numbers: See…
Dewei Medical Equipment Co. Recalls DNA/RNA Preservation Kits That Are Not Authorized, Cleared, or Approved by the FDA
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: Dewei Medical Equipment Co. DNA/RNA Preservation Kits Product Catalog Number: DW-80005-1B Distribution Dates: May 2020 to January 2022 Devices Recalled in the U.S.: 250,000 Date…
FDA D.I.S.C.O. Burst Edition: FDA approval of Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) and platinum-based chemotherapy for metastatic non-small cell lung cancer
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 November 10, 2022, the FDA approved tremelimumab (brand name…
Update on Endologix AFX Endovascular AAA Graft Systems and Risk of Type III Endoleak: FDA Safety Communication
Date Issued: December 6, 2022 The U.S. Food and Drug Administration (FDA) is updating our January 2022 safety communication on the use of Endologix AFX endovascular grafts used to treat patients with abdominal aortic aneurysm (AAA). On December 6, 2022, the FDA approved new labeling for the currently available product, the AFX2 Endovascular AAA System…
FDA D.I.S.C.O. Burst Edition: FDA approval of Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for non-small cell lung cancer
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 November 8, 2022, the FDA approved cemiplimab-rwlc (brand name…