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The HeartMate 3 Left Ventricular Assist System may allow blood to leak out or air to enter the system during implant of the LVAD device.
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BioMérieux Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations
BioMérieux is recalling their VITEK 2 AST cards, used for testing bacterial sensitivity to antibiotics, due to excessive Ceftriaxone in two wells.
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Draeger, Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power
The Perseus A500 that provides anesthesia and/or ventilation during surgical or diagnostic procedures may unexpectedly shutdown while using battery power.
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FDA Roundup: May 14, 2024
FDA Roundup: May 14, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-may-14-2024
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Philips Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction
Philips Respironics is recalling their Trilogy Evo ventilators due to a software-related possible power malfunction, leading to a sudden loss of ventilation.
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FDA Roundup: May 10, 2024
FDA Roundup: May 10, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-may-10-2024
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MEGADYNE™ Initiates Global Discontinuation and Voluntary Recall of MEGA SOFT™ Pediatric Patient Return Electrode
MEGADYNE™ is initiating a voluntary recall of all MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrodes. The product is being removed because Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used. A root cause investigation on
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Route 92 Medical Inc. Recalls Catheter due to Distal Tip Separation at the Proximal Marker Band
Route 92 Medical is recalling certain products that include Tenzing 7 Delivery Catheters due to instances of the catheter tip separating near the marker band.
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FDA Issues Final Guidance to Clarify “Remanufacturing” of Devices that Need Maintenance or Repair
FDA Issues Final Guidance to Clarify “Remanufacturing” of Devices that Need Maintenance or Repair
http://www.fda.gov/news-events/press-announcements/fda-issues-final-guidance-clarify-remanufacturing-devices-need-maintenance-or-repair
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EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology
EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology
http://www.fda.gov/news-events/press-announcements/epa-fda-and-usda-issue-joint-regulatory-plan-biotechnology