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 HawkOne Directional Atherectomy System Product Codes and Lot Numbers: See Recall Database Entry Devices Recalled in the United States: 95,110 Distribution Date: January 22, 2018 to October…
Florida Study Coordinator Sentenced in Scheme to Falsify Clinical Drug Trial Data
U.S. Department of Justice FOR IMMEDIATE RELEASEThursday, January 20, 2022 A federal judge sentenced a Florida man to 30 months in prison today in connection with his participation in a conspiracy to falsify clinical drug trial data. U.S. District Judge Robert N. Scola Jr. of the Southern District of Florida entered the sentence against Duniel Tejeda,…
UPDATE: Blood Specimen Collection Tube Conservation Strategies – Letter to Health Care and Laboratory Personnel
January 19, 2022 The U.S. Food and Drug Administration (FDA) is aware the United States is experiencing significant interruptions in the supply of several blood specimen collection (blood draw) tubes because of an increase in demand during the COVID-19 public health emergency and recent vendor supply challenges. The FDA is expanding the medical device shortage…
Problems with E-Cigarettes, Vape Products, Hookah, Cigarettes or Other Tobacco Products? Tell FDA
Español Have you used an e-cigarette, cigar, cigarette, hookah, smokeless tobacco or other tobacco product that you believe is not working properly or that is causing an unexpected health problem? Does the product have a strange taste or smell; has your vape battery exploded; or is there some other problem or concern? The U.S. Food…
Chiropractor Sentenced for Unlawful Distribution of Steroid-like Drugs
Department of JusticeU.S. Attorney’s OfficeWestern District of Virginia FOR IMMEDIATE RELEASEMonday, January 10, 2022 ABINGDON, Va. – A New Jersey chiropractor was sentenced to eight months of imprisonment for distributing steroid-like drugs as purported dietary supplements, the Department of Justice announced today. Nicholas Andrew Puccio, 41, of Columbus, New Jersey, pleaded guilty in June 2021…
Frozen Food Development Recalls Lidl Branded Chopped Spinach Because of Possible Health Risk
Summary Company Announcement Date: January 19, 2022 FDA Publish Date: January 19, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Listeria Monocytogenes Company Name: Frozen Food Development Brand Name: Brand Name(s) Product Description: Product Description Frozen Chopped Spinach Company Announcement Frozen Food Development is voluntarily recalling specific lots of Lidl branded…
Getinge USA Sales, LLC Recalls the Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems Due to a Risk of Harmful Chemical Exposure
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: Vaporizer Sevoflurane, Maquet Filling for Flow Family Anesthesia Systems Model Number: Model 6886601 Manufacturing Dates: December 15, 2020 to July 21, 2021 Distribution Dates: February…
Amy’s Kitchen Voluntarily Issues Allergy Alert on Undeclared Milk in a Single Lot of Vegan Organic Rice Mac & Cheeze
Summary Company Announcement Date: January 19, 2022 FDA Publish Date: January 19, 2022 Product Type: Food & Beverages Organic Food / Home Grown Allergens Reason for Announcement: Recall Reason Description Undeclared Milk Company Name: Amy’s Kitchen Brand Name: Brand Name(s) Product Description: Product Description Amy’s Vegan Organic Rice Mac & Cheese Company Announcement Petaluma, California…
FDA D.I.S.C.O. Burst Edition: FDA approval of Orencia (abatacept) for prophylaxis of acute graft versus host disease
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 December 15, 2021, the FDA approved abatacept (brand name…
Oscor Inc. Issues Voluntary Worldwide Recall of Destino Twist Steerable Guiding Sheath Due to the Risk of the Device Hub Cap and Seal on the Proximal End of the Device Handle Detachment During Use
Summary Company Announcement Date: January 12, 2022 FDA Publish Date: January 12, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Hub cap and seal on the proximal end of the device handle may detach during use Company Name: Oscor Inc. Brand Name: Brand Name(s) Product Description: Product Description Destino Twist 14F model…