Summary Company Announcement Date: October 08, 2024 FDA Publish Date: October 16, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Unapproved Drug Company Name: C&A Naturistics Brand Name: Brand Name(s) Product Description: Product Description AK Forte Dietary Supplement Company Announcement FOR IMMEDIATE RELEASE – 10/8/24 – National City,…
Infusion Pump Recall: Zyno Medical Removes Z-800, Z-800F, Z-800W, and Z800WF Infusion Pumps due to an Air-in-Line Software Defect That May Allow Larger than Expected Air Bubbles to Enter Patients
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Pump Model Unique Device Identifier (UDI-DI) Software Revision Z-800 00814377102006 6.1.01 and 6.1.07z Z-800W 00814371020020…
FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause. Stop Medicine if Signs and Symptoms of Liver Injury Occur – Drug Safety Communication
[Posted 9/12/2024] AUDIENCE: Patient, Health Professional, OBGYN, Endocrinology ISSUE: The FDA is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury and potentially return liver function to normal….
Infusion Pump Administration Set Recall: Fresenius Kabi USA Removes Certain Ivenix Large Volume Pump Primary Administration Sets
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Names: Ivenix LVP Primary Administration Sets Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25) Unique…
Philips Respironics Issues Additional Usage Instructions for Trilogy Evo Ventilators Related to Use of In-Line Nebulizers
Summary Company Announcement Date: October 07, 2024 FDA Publish Date: October 07, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description The use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this occur, there is a possibility of inaccurate flow…
Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitators due to Risk of Inline Controller Detachment that May Impact Ventilation
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Name: Neo-Tee T-Piece Resuscitator with manometer and controller with pressure relief valve Part Number…
Infusion Pump Correction: B. Braun Medical Inc. Issues Correction for lnfusomat Space Infusion System/Large Volume Pump, in addition to Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK, Due to Faulty Occlusion Alarm
This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Product Names: lnfusomat Space Infusion System/Large Volume…
Tracheostomy Tube Recall: Smiths Medical Removes Certain Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes due to Manufacturing Defect that May Cause Tracheostomy Displacement or Decannulation
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Image of torn flange due to manufacturing defect. Product Names: Bivona Aire-Cuf, TTS, Uncuffed, Mid-Range…
Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination
Summary Company Announcement Date: September 17, 2024 FDA Publish Date: September 18, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Product found to be contaminated with Cohnella bacteria Company Name: Bionpharma Inc. Brand Name: Brand Name(s) BionPharma Product Description: Product Description Atovaquone Oral Suspension, 750 mg/mL Company Announcement FOR IMMEDIATE RELEASE – September…
Related Recalls – Plastic Syringes Made in China for Potential Device Failures
Cypress Medical Products General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson… Sol-Millennium Medical Inc. Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/… Sol-Millennium Medical Inc. Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w… Sol-Millennium…