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Endovascular System Recall: Philips Removes and Discontinues Distribution of Tack Endovascular System Due to User Challenges That Caused Additional Procedures to Reposition or Remove Implant

Murilo Freitas - 05:00, 2 de March de 202563
Tack Endovascular System is used to repair artery dissection after angioplasty but ongoing user issues led Philips to discontinue use and distribution.

http://www.fda.gov/medical-devices/medical-device-recalls/endovascular-system-recall-philips-removes-and-discontinues-distribution-tack-endovascular-system

 
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Vaporizer Recall: Getinge Removes Vaporizer Sevoflurane Quick-Fil and Expands Recall of Vaporizer Sevoflurane Maquet Filling due to Risk of Patient and Health Care Professional Exposure to Toxic Chemical Hydrogen Fluoride

Murilo Freitas - 05:00, 2 de March de 2025126
Vaporizers Sevoflurane Quick-Fil and Maquet Filling mix oxygen and sevoflurane for anesthesia. This sevoflurane may degrade to toxic hydrogen fluoride.

http://www.fda.gov/medical-devices/medical-device-recalls/vaporizer-recall-getinge-removes-vaporizer-sevoflurane-quick-fil-and-expands-recall-vaporizer

 
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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 2025117
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

 
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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 2025156
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

 
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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 202574
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

 
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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 202583
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

 
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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 2025185
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

 
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