Blog – Page 20 – 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

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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

Murilo Freitas - 04:00, 14 de July de 2025390

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

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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 2025195

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

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

Murilo Freitas - 04:00, 13 de July de 2025195

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

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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

Murilo Freitas - 15:03, 9 de July de 2025222

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

Murilo Freitas - 12:17, 9 de July de 2025258

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

Murilo Freitas - 04:00, 9 de July de 2025245

Select Ballard Closed Suction Systems lots may not be sterilized, increasing risk of infection, airway injury, prolonged inflammation, sepsis, or death if used.

http://www.fda.gov/medical-devices/medical-device-recalls/closed-suction-catheter-recall-avanos-medical-inc-removes-ballard-closed-suction-systems-due-risk