The U.S. Food and Drug Administration (FDA) is emphasizing to physicians and other health care providers the importance of lifelong surveillance, including imaging, for patients with abdominal aortic aneurysm (AAA) endovascular aortic repair (EVAR). Regular imaging surveillance, within 30-days of EVAR and annually thereafter, may help identify adverse events such as endoleaks, device migration, loss…
Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Percutaneous Thrombolytic Device Due to Risk of Tip Damage During Use
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-Trerotola Percutaneous Thrombolytic Device (PTD) Model Number: See Recall Database Entry Manufacturing Dates: January 1, 2020 to December 31, 2021 Distribution Dates: February 1, 2020…
BASE10 Genetics Recalls RNAstill MTM Specimen Collection Kits That Are Not Authorized, Cleared, or Approved by the FDA, May Give False Results, and Require Special Training for Safe Handling
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: RNAstill MTM specimen collection kits Product Codes: See Recall Database Entry Distribution Dates: September 16, 2020 to December 1, 2021 Devices Recalled in the U.S.:…
E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False 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 (Include the following information) Product Names: E25Bio COVID-19 Direct Antigen Rapid Test; Trade Name: E25Bio SARS-CoV-2 Antigen Test Kit Product Codes and Model Numbers: See Recall Database…
Baxter Issues Urgent Safety Communication to Reinforce Important Safety Information Regarding Upstream Occlusion Alarms for all Spectrum V8 and Spectrum IQ Infusion Pumps
Summary Company Announcement Date: February 17, 2022 FDA Publish Date: February 18, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for alarm malfunction Company Name: Baxter International Inc. Brand Name: Brand Name(s) SIGMA Spectrum V8 and Spectrum IQ Product Description: Product Description Spectrum V8 and Spectrum IQ infusion pumps Company Announcement…
Vyaire Medical Recalls bellavista 1000 and 1000e Series Ventilators Due to Issues with Software Configurations
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: Vyaire Medical Bellavista 1000 and 1000e Series Ventilators Product Codes: See Recall Database Entry Catalog Numbers: 301.100.030; 301.100.130 Distribution Dates: January 26, 2017 to December…
TCP HOT Acquisition LLC dba HRB Brands Issues Voluntary Nationwide Recall of Sure and Brut Aerosol Sprays Due to the Presence of Benzene
Summary Company Announcement Date: February 16, 2022 FDA Publish Date: February 16, 2022 Product Type: CosmeticsDrugs Deodorant Reason for Announcement: Recall Reason Description Presence of benzene Company Name: TCP HOT Acquisition LLC dba HRB Brands Brand Name: Brand Name(s) Sure, Brut Product Description: Product Description Aerosol deodorant and antiperspirant sprays Company Announcement FOR IMMEDIATE RELEASE…
FDA D.I.S.C.O. Burst Edition: FDA approves tebentafusp-tebn for unresectable or metastatic uveal melanoma
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 January 25, 2022, the FDA approved tebentafusp-tebn (brand name…
ABC SALES 1 INC Issues Voluntary Nationwide Recall of MAC DADDY RED and MAC DADDY PURPLE Capsules Due to the Presence of Undeclared Sildenafil and Tadalafil
Summary Company Announcement Date: February 08, 2022 FDA Publish Date: February 08, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and/or Tadalafil Company Name: ABC SALES 1 INC Brand Name: Brand Name(s) Product Description: Product Description MAC DADDY RED and PURPLE DIETARY SUPPLEMENTS Company Announcement FOR IMMEDIATE RELEASE – 2/8/22 –…
Positive-Health Issues Voluntary Nationwide Recall of RISE UP RED EDITION Capsules Due to the Presence of Undeclared Tadalafil
Summary Company Announcement Date: February 10, 2022 FDA Publish Date: February 10, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil Company Name: Positive-Health Brand Name: Brand Name(s) Positive-Health Product Description: Product Description Rise Up Red Edition Capsules Company Announcement FOR IMMEDIATE RELEASE – 2/10/22 – Wilmington DE, Positive-Health is voluntarily recalling…