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Early Alert: Infusion Set Performance Issue from BD
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.
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Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone Peeling or Detaching During Use
HemoPro EVH Systems have updated instructions related to bent/detached heater wires and peeling/detaching silicone during minimally invasive surgery.
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Safety and Availability Concerns with VasoView HemoPro Endoscopic Vessel Harvesting Systems – Letter to Health Care Providers
The FDA is alerting health care providers to the recall of certain VasoView HemoPro devices due to risk of silicone detachment during use, and supply concerns.
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FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3
FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3
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Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry
Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfa
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A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: 100 Days of Embracing Gold-Standard Science, Transparency and Common Sense
A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: 100 Days of Embracing Gold-Standard Science, Transparency and Common Sense
http://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph-100-days-embracing-gold-standard-science-transparency
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FDA Embraces Radical Transparency by Publishing Complete Response Letters
FDA Embraces Radical Transparency by Publishing Complete Response Letters
http://www.fda.gov/news-events/press-announcements/fda-embraces-radical-transparency-publishing-complete-response-letters
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Closed Suction Catheter Recall: Avanos Medical, Inc. Removes Ballard Closed Suction Systems Due to Risk of Non-Sterility
Select Ballard Closed Suction Systems lots may not be sterilized, increasing risk of infection, airway injury, prolonged inflammation, sepsis, or death if used.
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FDA Encourages Industry Leaders to Streamline, Enhance Product Recall Communications to Safeguard Foods for Infants and Children
FDA Encourages Industry Leaders to Streamline, Enhance Product Recall Communications to Safeguard Foods for Infants and Children
http://www.fda.gov/news-events/press-announcements/fda-encourages-industry-leaders-streamline-enhance-product-recall-communications-safeguard-foods
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Infant Breathing System Recall: AirLife/Vyaire Removes Infant Heated Wire Circuits Due to Risk for Inadvertent Adapter Disconnection During Ventilation
AirLife Infant Heated Wire Circuits heat up gas during ventilation. An included adapter may disconnect when the device reaches operating temperature.
