Murilo Freitas – Page 2

Ventilator Correction: Baxter Updates Use Instructions for Volara Single-Patient Use Circuits

Murilo Freitas - 04:00, 8 de April de 2026120

When the Volara system is used in a home setting, there is a risk for oxygen desaturation or barotrauma if it is used in-line with a ventilator. 

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/ventilator-correction-baxter-updates-use-instructions-volara-single-patient-use-circuits

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Early Alert: Sizing Catheter Issue from Cook Medical

Murilo Freitas - 04:00, 8 de April de 2026116

When the sizing catheters are used during angiographic procedures the marker bands may be at an increased risk of cracking/breakage.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-sizing-catheter-issue-cook-medical

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Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination

Murilo Freitas - 04:00, 7 de April de 2026131

Santa Fe Springs, California – April 07, 2026 – Blaine Labs, Inc. is voluntarily recalling three (3) lot numbers of Wound Care Gel products, 1 oz. & 3 oz. (0.1% Benzalkonium Chloride) to the consumer level due to microbial contamination.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blaine-labs-inc-issues-voluntary-nationwide-recall-wound-care-gel-products-due-microbial

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Purge Cassette Recall: Abiomed Removes Impella Heart Pump Purge Cassettes

Murilo Freitas - 04:00, 2 de April de 2026190

Impella Generation 1 Purge Cassettes have an increased risk of purge leaks. Purge leaks can lead to low pump pressure and pump stops.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/purge-cassette-recall-abiomed-removes-impella-heart-pump-purge-cassettes

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Heart Pump Correction: Abiomed Updates Use Instructions for Impella RP with SmartAssist Devices

Murilo Freitas - 04:00, 2 de April de 202699

The differential pressure sensor in certain Impella devices may malfunction and cause sensor values to drift.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/heart-pump-correction-abiomed-updates-use-instructions-impella-rp-smartassist-devices

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FDA Approves First New Molecular Entity Under National Priority Voucher Program

Murilo Freitas - 15:23, 31 de March de 2026180

FDA Approves First New Molecular Entity Under National Priority Voucher Program
http://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program

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Aphreseller (Buy-herbal.com) Issues Voluntary Nationwide Recall of Kian Pee Wan Capsules Due the Presence of Undeclared Dexamethasone and Cyproheptadine

Murilo Freitas - 04:00, 31 de March de 202672

FOR IMMEDIATE RELEASE – 03/30/2026 – Flushing, New York, Aphreseller (Ebay seller ID), Buy-herbal.com is recalling all lots of Kian Pee Wan capsules to the consumer level. FDA analysis has found that the product contains the undeclared drug ingredients dexamethasone and cyproheptadine. Products cont

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aphreseller-buy-herbalcom-issues-voluntary-nationwide-recall-kian-pee-wan-capsules-due-presence

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