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Integra is removing certain Wound and Burn Dressing products that may have breached sterile barriers.
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FDA Grants Third Approval Under the National Priority Voucher Program
FDA Grants Third Approval Under the National Priority Voucher Program
http://www.fda.gov/news-events/press-announcements/fda-grants-third-approval-under-national-priority-voucher-program
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FDA to Address Unused Opioids in American Homes
FDA to Address Unused Opioids in American Homes
http://www.fda.gov/news-events/press-announcements/fda-address-unused-opioids-american-homes
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Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
Certain reprocessed catheters may contain residual particulates that could cause infection, embolism, or thrombosis
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Catheter Recall: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
Certain reprocessed catheters may contain residual particulates that could cause infection, embolism, or thrombosis.
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Update: FDA Encourages the Public to Follow Established Choking Rescue Protocols – FDA Safety Communication
These choking rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults but not anti-choking devices.
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FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s
FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s
http://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s
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FDA Grants Second Approval under the National Priority Voucher Pilot Program
FDA Grants Second Approval under the National Priority Voucher Pilot Program
http://www.fda.gov/news-events/press-announcements/fda-grants-second-approval-under-national-priority-voucher-pilot-program
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Early Alert: Heart Pump Purge Cassette Issue from Abiomed
Impella Generation 1 Purge Cassettes have an increased risk of purge leaks. Purge leaks can lead to low pump pressure and pump stops
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Infusion Pump Software Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Pump Software
Fresenius Kabi is correcting Ivenix LVP software due to anomalies that could cause serious patient harm or death