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: Tablo Hemodialysis Device Product Codes: See Recall Database Entry Devices Recalled in the U.S.: 879 Dates Distributed: August 25, 2018 to December 4, 2023 Date…
InfuTronix, LLC Recalls Nimbus and Nimbus II Infusion Pump Systems for Multiple Device Failures That May Cause Severe Injury and Death
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: Nimbus: Administration Set, Flex, PainPro, also known as the Halo Ambulatory Infusion System Nimbus II: PainPRO, Flex, Plus, EpiD, and EMS Product Codes: See Recall…
Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA
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: Stay-Safe Catheter Extension Sets, Stay-Safe/Luer Lock Adapter Product Codes: See Recall Database Entries: Devices Recalled in the U.S.: 2,192,535 Dates Distributed: March 5, 2003 to…
Tama Corporation Recalls Product Because of Possible Health Risk
Summary Company Announcement Date: April 25, 2024 FDA Publish Date: April 26, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes Company Name: TAMA Corporation Brand Name: Brand Name(s) Product Description: Product Description Queso de Mano PAISA Company Announcement Tama Corporation of Doral FL is…
FDA D.I.S.C.O. Burst Edition: FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-positive solid tumors
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 April 5, 2024, the FDA granted accelerated approval to…
Elekta Instrument AB Recalls Disposable Biopsy Needle Kit for Leksell Stereotactic System for Possibly Containing Microscopic Stainless Steel Debris on the Inside of the Biopsy Needle
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: Disposable Biopsy Needles (911933) Product Codes: HAW Lot Number: 837838839 Distribution Dates: August 29, 2023 to January 5, 2024 Devices Recalled in the U.S.: 10…
Draeger, Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power
Please be aware, this recall is a correction, not a product removal. 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: Perseus A500 Product Codes: See Recall Database Entry Devices Recalled in the U.S.:…
DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley Under Recall by Nurse Assist
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: GeoMed Custom Tracecarts Product Codes: LRO Model Numbers: 53-1829 Laminectomy Tracecart 53-1831 Ortho Total Joint Tracecart 53-1836 General Surgery Tracecart Distribution Dates: August 25, 2022…
Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency
Summary Company Announcement Date: April 23, 2024 FDA Publish Date: April 23, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Decreased Potency Company Name: Dr. Reddy’s Laboratories Inc Brand Name: Brand Name(s) Dr. Reddy’s Product Description: Product Description Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Company Announcement FOR IMMEDIATE RELEASE Hyderabad India…
Dallas Anesthesiologist Convicted of Tampering with IV Bags Linked to Cardiac Emergencies During Routine Surgeries
Department of JusticeOffice of Public Affairs FOR IMMEDIATE RELEASEFriday, April 12, 2024 A Dallas anesthesiologist was convicted today for injecting dangerous drugs into patient IV bags, leading to one death and numerous cardiac emergencies, the Justice Department announced. Raynaldo Riviera Ortiz Jr., 60, was charged by criminal complaint in September 2023 and indicted the following…