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: iCast Covered Stent Product Lot Numbers: See recall database entry Distribution Dates: December 31, 2018, to March 31, 2022 Devices Recalled in the U.S.: 68,812…
Urban Remedy Recalls Urban Remedy Organic Revitalizing Tea Tonic – Strawberry Hibiscus Rose Due to Possible Hepatitis A Contamination
Summary Company Announcement Date: June 03, 2022 FDA Publish Date: June 05, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to be contaminated with Hepatitis A. Company Name: Urban Remedy Brand Name: Brand Name(s) Urban Remedy Product Description: Product Description Organic Revitalizing Tea Tonic Strawberry Hibiscus Rose Company Announcement Urban…
Illumina Cybersecurity Vulnerability May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers
June 2, 2022 The U.S. Food and Drug Administration (FDA) is informing laboratory personnel and health care providers about a cybersecurity vulnerability affecting software in the Illumina NextSeq 550Dx, the MiSeqDx, the NextSeq 500, NextSeq 550, MiSeq, iSeq, and MiniSeq, next generation sequencing instruments. These instruments are medical devices that may be specified either for…
Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms
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: Philips Respironics V60 and V60 Plus Ventilator Product Codes and Serial Numbers See recall database entries: Distribution Dates: May 1, 2009 to December 22, 2021…
FDA D.I.S.C.O. Burst Edition: FDA approval of Vidaza (azacytidine) for pediatric patients with newly diagnosed juvenile myelomonocytic 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’ll provide another quick update on a recent FDA cancer drug approval. On May 20, 2022, the FDA approved azacitidine (brand name…
Former Malden Firefighter Charged with Possession and Distribution of Controlled Substances
Department of JusticeDistrict of Massachusetts FOR IMMEDIATE RELEASEWednesday, June 1, 2022 BOSTON – A former Malden firefighter has been charged and has agreed to plead guilty in connection with conspiring to distribute controlled substances including oxycodone, suboxone, Klonopin and Adderall. Joshua Eisnor, 43, of North Reading, was charged by an Information with conspiracy to distribute and…
Irvington Seafood Recalls “Crabmeat: Jumbo, Lump, Finger, and Claw Meat” Because of Possible Health Risk
Summary Company Announcement Date: June 02, 2022 FDA Publish Date: June 03, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes Company Name: Irvington Seafood Inc. Brand Name: Brand Name(s) Irvington Seafood Product Description: Product Description Crabmeat: Jumbo, Lump, Finger, and Claw meat Company Announcement…
Baxter Issues Urgent Medical Device Correction to Reinforce Important Safety Information Regarding Possible Risk of Oxygen Desaturation While Using Volara Device in Line With Ventilator in a Home Care Environment
Summary Company Announcement Date: June 01, 2022 FDA Publish Date: June 02, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Possible risk of oxygen desaturation Company Name: Baxter International Inc. Brand Name: Brand Name(s) Product Description: Product Description Volara System (home care) Company Announcement Deerfield, Ill. – 2022-06-01 – Baxter International Inc….
Pittsfield Nurse Pleads Guilty to Stealing Fentanyl from Critical Care Patient
Department of JusticeDistrict of Massachusetts FOR IMMEDIATE RELEASETuesday, May 31, 2022 BOSTON – A Pittsfield woman pleaded guilty today in federal court in Springfield to stealing fentanyl being administered to a patient in the critical care unit. Jessica Lotto, 36, pleaded guilty to one count of acquiring a controlled substance by fraud, deceit or subterfuge. U.S….
Doctor Selling COVID-19 “Cure” Sentenced to Prison
Department of JusticeSouthern District of California FOR IMMEDIATE RELEASEFriday, May 27, 2022 SAN DIEGO – Jennings Ryan Staley, a physician who attempted to profit from the pandemic by marketing what he described as a “miracle cure” for COVID-19, was sentenced today to 30 days of custody and one year of home confinement for trying to smuggle…