Blog – Page 33 – PRAIS 2.0

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.

http://www.fda.gov/medical-devices/letters-health-care-providers/safety-and-availability-concerns-vasoview-hemopro-endoscopic-vessel-harvesting-systems-letter-health

rss

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

Murilo Freitas - 04:00, 14 de July de 2025496

HemoPro EVH Systems have updated instructions related to bent/detached heater wires and peeling/detaching silicone during minimally invasive surgery.

http://www.fda.gov/medical-devices/medical-device-recalls/endoscopic-vessel-harvesting-evh-system-correction-getinge-and-maquet-cardiovascular-update-use

rss

FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3

Murilo Freitas - 12:59, 13 de July de 2025299

FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3

http://www.fda.gov/news-events/press-announcements/fda-approves-gardenia-genipin-blue-color-additive-while-encouraging-faster-phase-out-fdc-red-no-3

rss

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry

Murilo Freitas - 04:00, 13 de July de 2025292

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

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-issues-voluntary-nationwide-recall-sucralfate-tablets-usp-1-gram-within

rss

A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: 100 Days of Embracing Gold-Standard Science, Transparency and Common Sense

Murilo Freitas - 15:03, 9 de July de 2025345

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

rss

FDA Embraces Radical Transparency by Publishing Complete Response Letters

Murilo Freitas - 12:17, 9 de July de 2025322

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