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 Angiographic Guidewire Component Model Numbers: WIRE ANGIO 107042 PNS .035X145 3MMJ PTFE; Part No: 107042 WIRE ANGIO 107044 PNS .038X145 3MMJ PTFE; Part No: 107044 WIRE ANGIO…
Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low 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. Recalled Product LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Lot codes: LeadCare II: 2013M, 2014M, 2015M, 2016M, 2017M, 2101M, 2103M, 2105M, 2106M, and 2107M LeadCare Plus and LeadCare…
Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
Date Issued: June 30, 2021 The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to…
Stop Using Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication
Date Issued: June 10, 2021 The U.S. Food and Drug Administration (FDA) is warning the public to stop using the Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health. In addition, labeling…
Perro bueno, alimento malo: alimentos para las personas que son malos para su perro
English Si considera al perro de la familia, pues, como de la familia—y no duda en arrojarle un trozo de su plato de vez en cuando, tenga cuidado. Algunos alimentos destinados para consumo humano pueden ser peligrosos, e incluso mortales, para su perro. ¿En qué sentido son las personas y los animales diferentes en lo…
Flexible Bronchoscopes and Updated Recommendations for Reprocessing: FDA Safety Communication
Date Issued: June 25, 2021 The U.S. Food and Drug Administration (FDA) is providing updated information about medical device adverse event reports and recommendations for health care providers on bronchoscopes. This is a supplement to the 2015 safety communication on reprocessed flexible bronchoscopes. Recommendations for Patients and Caregivers The recommendations have not changed from the…
Smiths Medical Recalls Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes for Skewed Graduated Marks on Syringe Barrel That May Cause Insulin Overdose or Underdose
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 Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes Models and Lot Model Number Name Lot Number 4428-1 Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 28Gx1/2” 1CC 4046543, 4062235…
Avid Medical Recalls Medical Convenience Kits for Risk of Fungal Contamination
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 Adult Chest Tube Tray Fistula On-Off Kit Fistula (On/Off All in One bag) Dialysis Access Part and Lot Numbers: See “Full List of Affected Devices” Distribution Dates:…
DeRoyal Industries Recalls Surgical Procedure Packs for Mislabeled Lidocaine
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 DeRoyal Pacemaker Tray Pgybk Lot Number 54239375, exp. 02/01/2022 DeRoyal Heart Cath Procedure Pack Lot Numbers: 54310362, exp. 01/01/2022; 54366825, exp. 01/01/2022 DeRoyal Angio Cath Removal Tray…
FDA D.I.S.C.O. Burst Edition: FDA approval of Ayvakit (avapritinib) for adult patients with advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, and mast cell leukemia
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 have another quick update on a recent FDA cancer drug approval. On June 16, 2021, the FDA approved avapritinib (brand name…