Summary Company Announcement Date: December 21, 2022 FDA Publish Date: December 21, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of nitrosamine impurity, N-Nitroso-Quinapril Company Name: Lupin Pharmaceuticals Inc. Brand Name: Brand Name(s) Product Description: Product Description Quinapril 20 and 40 mg tablets Company Announcement Baltimore, Maryland, December 21, 2022: Lupin Pharmaceuticals…
Arrow International, LLC, subsidiary of Teleflex, Inc Recalls Arrow AutoCAT 2, AC3 Intra-Aortic Balloon Pumps for Unexpectedly Short Battery Run Times
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…
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…
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…
UPDATE: Impella RP System Post-Approval Study Results and Updated Labeling – Letter to Health Care Providers
December 5, 2022 The U.S. Food and Drug Administration (FDA) is issuing this update to our previous letter to health care providers to inform the health care community of the final post-approval study (PAS) results and updated labeling for the Impella RP System manufactured by Abiomed. The final PAS results show that the survival rate…
Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) Shortage – Letter to Health Care Providers
December 2, 2022 The U.S. Food and Drug Administration (FDA) is alerting health care facilities and providers of a shortage of Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including limited supplies of IAB catheters, new Cardiosave IABPs, and Cardiosave IABP parts. Recommendations The FDA recommends that health care facilities and providers who use Getinge Maquet/Datascope…