Murilo Freitas – Page 6

FDA Roundup: February 28, 2025

Murilo Freitas - 20:44, 27 de February de 2025130

FDA Roundup: February 28, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-february-28-2025

Regard Newborn Kit Recall: ROi CPS, LLC Removes Certain Newborn Kits Due to a Recalled Component, the Neo-Tee T-Piece Resuscitator With An Undersized Controller Spring

Murilo Freitas - 05:00, 27 de February de 2025111

ROi newborn kits include Neo-Tee T-Piece Resuscitators. The Neo-Tee may have an undersized controller spring that could affect patient breathing support.

http://www.fda.gov/medical-devices/medical-device-recalls/regard-newborn-kit-recall-roi-cps-llc-removes-certain-newborn-kits-due-recalled-component-neo-tee-t

rss rss-es rss-pt

Endoscope Instrument Recall: Olympus Removes Single Use Guide Sheath Kits Due to Risk for Radiopaque Guide Sheath Tip Detaching During Procedures

Murilo Freitas - 05:00, 27 de February de 2025144

Olympus Guide Sheath Kits collect samples from breathing organs through an endoscope. The tip of the guide sheath may detach during a procedure.

http://www.fda.gov/medical-devices/medical-device-recalls/endoscope-instrument-recall-olympus-removes-single-use-guide-sheath-kits-due-risk-radiopaque-guide

rss

Patient Table Correction: Philips Updates Use Instructions for Allura and Azurion Systems due to Patient Fall Risk from Incorrectly Positioned Mattresses

Murilo Freitas - 05:00, 27 de February de 202566

Philips Allura and Azurion interventional fluoroscopy systems are used in operating rooms. Incorrectly positioned mattresses may cause patient falls and injuries.

http://www.fda.gov/medical-devices/medical-device-recalls/patient-table-correction-philips-updates-use-instructions-allura-and-azurion-systems-due-patient

rss

Ablation Catheter Correction: Biosense Webster Updates Use Instructions for Varipulse due to High Rate of Stroke or Transient Ischemic Attack

Murilo Freitas - 05:00, 27 de February de 202575

Biosense Webster updated Instructions for Use for Varipulse due to higher-than-anticipated incidence of peri-procedural stroke or transient ischemic attack.

http://www.fda.gov/medical-devices/medical-device-recalls/ablation-catheter-correction-biosense-webster-updates-use-instructions-varipulse-due-high-rate

rss

Natural Dior LLC Issues Voluntary Nationwide Recall of Vitafer-L Gold Liquid Due to Presence of Undeclared Tadalafil

Murilo Freitas - 05:00, 25 de February de 2025170

February 25, 2025 – Natural Dior LLC, is voluntarily recalling the affected lots of Vitafer-L Gold Liquid, a dietary supplement with iron and vitamins, to the consumer level. The product has been found to contain undeclared tadalafil, an ingredient in FDA approved products for treatment of male erec

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/natural-dior-llc-issues-voluntary-nationwide-recall-vitafer-l-gold-liquid-due-presence-undeclared

rss

Ascent Consumer Products Inc. Issues Voluntary Nationwide Recall of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System Due to Microbial Contamination

Murilo Freitas - 05:00, 24 de February de 2025206

02/25/2025 Melville, NY. Ascent Consumer Products Inc. is voluntarily recalling one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System to the consumer level. The recall is being initiated due to a confirmed test result of microbial contamination of the product with Staphylococcus aureus (S

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ascent-consumer-products-inc-issues-voluntary-nationwide-recall-sinucleanse-soft-tip-squeeze-bottle

rss

Central Admixture Pharmacy Services (CAPS) Issues Nationwide Recall of Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags Due to Visible Black Particulate Matter in a Single-Sealed Vial

Murilo Freitas - 05:00, 24 de February de 2025149

February 24, 2025 – Bethlehem, PA. Central Admixture Pharmacy is recalling three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags (NDC: 71285-6092-1) to the hospital level. The product is being recalled because CAPS was notified by their raw material supplier of

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/central-admixture-pharmacy-services-caps-issues-nationwide-recall-phenylephrine-40-mg-added-09

rss

FDA Approves First Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disease

Murilo Freitas - 16:47, 20 de February de 2025123

FDA Approves First Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disease
http://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-cerebrotendinous-xanthomatosis-rare-lipid-storage-disease

rss

Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement – FDA Safety Communication

Murilo Freitas - 05:00, 20 de February de 2025150

Read the FDA’s recommendations related to Accolade pacemaker devices by Boston Scientific and a potential need for early device replacement.

http://www.fda.gov/medical-devices/safety-communications/accolade-pacemaker-devices-boston-scientific-and-potential-need-early-device-replacement-fda-safety