Blog – Page 66 – PRAIS 2.0

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 2024218

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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PAHO Director Concludes Visit to Jamaica

admin - 17:42, 8 de May de 2024309

PAHO Director Concludes Visit to Jamaica

Cristina Mitchell

9 May 2024

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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 2024305

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 2024347

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 2024380

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

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Safety and Quality Concerns with Getinge Cardiovascular Devices – Letter to Health Care Providers

Murilo Freitas - 04:00, 7 de May de 2024240

Health care providers and facilities should begin to transition away from these devices and seek alternatives.

http://www.fda.gov/medical-devices/letters-health-care-providers/safety-and-quality-concerns-getinge-cardiovascular-devices-letter-health-care-providers