Categories
Dimension Vista System – A1-Antitrypsin Assay (2018-05-22)
Dimension Vista System – A1-Antitrypsin Assay (2018-05-22)
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/66980r-eng.php
Categories
N Latex CDT (Carbohydrate-Deficient Transferrin) Kit (2018-05-24)
N Latex CDT (Carbohydrate-Deficient Transferrin) Kit (2018-05-24)
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/66982r-eng.php
Categories
Endo GIA Reload w/Tri-Staple Technology Med/Thick, Endo GIA Curved Tip Reload w/Tri-Staple Technology Vascular and Vascular/Medium, and Endo GIA Gray Articulating Reload Extra Thin/Vascular (2018-05-23)
Endo GIA Reload w/Tri-Staple Technology Med/Thick, Endo GIA Curved Tip Reload w/Tri-Staple Technology Vascular and Vascular/Medium, and Endo GIA Gray Articulating Reload Extra Thin/Vascular (2018-05-23)
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/66988r-eng.php
Categories
Revisão da RDC 185 inova no processo de participação social
Formulário e-participa permitirá a instituições e à sociedade em geral o envio de contribuições durante todo o período de reformulação da resolução.
http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4501140
Categories
Agência cria novo canal para participação social
Formulário e-participa permite o envio de contribuições pela sociedade durante processos de revisão de normas. Inovação será usada na reformulação da RDC 185.
http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4498950
Categories
Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers – New Labeling About Potential Risks
FDA has approved new labeling for the Orbera and ReShape balloon systems with more information about possible death associated with the use of these devices.
Categories
Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall – Due to the Potential Presence of Particulate Matter
The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.
Categories
Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall – Due to the Potential Presence of Particulate Matter
The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.
