Murilo Freitas – Page 49

BioMérieux Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations

Murilo Freitas - 04:00, 14 de May de 2024598

BioMérieux is recalling their VITEK 2 AST cards, used for testing bacterial sensitivity to antibiotics, due to excessive Ceftriaxone in two wells.

http://www.fda.gov/medical-devices/medical-device-recalls/biomerieux-inc-recalls-vitek-2-ast-kit-due-incorrect-ceftriaxone-concentrations

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Draeger, Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power

Murilo Freitas - 04:00, 14 de May de 2024294

The Perseus A500 that provides anesthesia and/or ventilation during surgical or diagnostic procedures may unexpectedly shutdown while using battery power.

http://www.fda.gov/medical-devices/medical-device-recalls/draeger-inc-recalls-perseus-a500-anesthesia-system-risk-sudden-unexpected-shutdown-when-used-battery

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FDA Roundup: May 14, 2024

Murilo Freitas - 17:51, 13 de May de 2024565

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

Murilo Freitas - 04:00, 12 de May de 2024466

Philips Respironics is recalling their Trilogy Evo ventilators due to a software-related possible power malfunction, leading to a sudden loss of ventilation.

http://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-inc-recalls-trilogy-evo-continuous-ventilators-due-software-related-possible

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FDA Roundup: May 10, 2024

Murilo Freitas - 20:00, 9 de May de 2024398

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

Murilo Freitas - 04:00, 9 de May de 2024406

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

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/megadynetm-initiates-global-discontinuation-and-voluntary-recall-mega-softtm-pediatric-patient

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Route 92 Medical Inc. Recalls Catheter due to Distal Tip Separation at the Proximal Marker Band

Murilo Freitas - 04:00, 9 de May de 2024268

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.

http://www.fda.gov/medical-devices/medical-device-recalls/route-92-medical-inc-recalls-catheter-due-distal-tip-separation-proximal-marker-band

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FDA Issues Final Guidance to Clarify “Remanufacturing” of Devices that Need Maintenance or Repair

Murilo Freitas - 13:59, 8 de May de 2024360

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

Murilo Freitas - 18:36, 7 de May de 2024427

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

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Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion

Murilo Freitas - 04:00, 7 de May de 2024485

Tandem Diabetes Care, Inc. recalls t:connect mobile app (v2.7) for t:slim X2 insulin pump due to software issue that may cause app to crash and deplete pump battery

http://www.fda.gov/medical-devices/medical-device-recalls/tandem-diabetes-care-inc-recalls-version-27-apple-ios-tconnect-mobile-app-used-conjunction-tslim-x2