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NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonates

Murilo Freitas - 04:00, 12 de julio de 2023318
NOxBOXi delivers inhaled nitric oxide therapy to neonates. If the manifold fails, therapy may be interrupted and the patient may experience oxygen desaturation.

http://www.fda.gov/medical-devices/medical-device-recalls/noxbox-ltd-recalls-noxboxi-nitric-oxide-system-manifold-failure-may-cause-gas-leaks-and-interrupt

 
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UPDATE: Risk of Mortality Associated with Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease is No Longer Supported Based on Data and Analyses – Letter to Health Care Providers

Murilo Freitas - 04:00, 10 de julio de 2023257
Available data no longer supports a probable late mortality risk associated with paclitaxel-coated devices used to treat femoropopliteal disease.

http://www.fda.gov/medical-devices/letters-health-care-providers/update-risk-mortality-associated-paclitaxel-coated-devices-treat-peripheral-arterial-disease-no

 
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UPDATE: Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality – Letter to Health Care Providers

Murilo Freitas - 04:00, 10 de julio de 2023288
Available data no longer supports a probable late mortality risk associated with paclitaxel-coated devices used to treat femoropopliteal disease.

http://www.fda.gov/medical-devices/letters-health-care-providers/update-paclitaxel-coated-devices-treat-peripheral-arterial-disease-unlikely-increase-risk-mortality

 
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Cipla Issues Voluntary Nationwide Recall of Six Batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) Due to Container Defect

Murilo Freitas - 04:00, 6 de julio de 2023328
Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as «Cipla»), today announced that its wholly-owned subsidiary Cipla US is voluntarily recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021 to the consumer leve

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cipla-issues-voluntary-nationwide-recall-six-batches-albuterol-sulfate-inhalation-aerosol-90-mcg-200

 
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Illumina Cybersecurity Vulnerability Affecting the Universal Copy Service Software May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers

Murilo Freitas - 04:00, 6 de julio de 2023338
Illumina cybersecurity vulnerability affecting the Universal Copy Service software may impact patient health results.

http://www.fda.gov/medical-devices/letters-health-care-providers/illumina-cybersecurity-vulnerability-affecting-universal-copy-service-software-may-present-risks

 
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