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Early Alert: Insulin Pump Issue from Insulet
Omnipod Pods may not deliver insulin as intended due to a tear in the internal tubing
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Early Alert: Handy Solutions Neck & Shoulders Heating Pad Issue from Navajo Manufacturing Company
Navajo Manufacturing company is recalling certain heating pads that overheat when folded leading to potential burn injuries
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Dialysis Tubing Set Correction: Vantive Updates Use Instructions for Prismaflex and Oxiris Sets
Prismaflex Set deaeration chambers may dislodge from the Prismaflex Control Unit during use.
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Convenience Kit Needle Recall: Integra LifeSciences Removes Tuohy Needle
Integra LifeSciences is removing certain lots of Microsensor and Cerelink ICP Kits with potential corrosion stains on the included Tuohy Needle.
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Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® 5 Pods in the U.S.
ACTON, Mass.–(BUSINESS WIRE)– Insulet Corporation (NASDAQ: PODD) (“Insulet” or the “Company”) today initiated a voluntary Medical Device Correction for specific lots of Omnipod® 5 Pods after identifying a manufacturing issue through its ongoing product monitoring. This action applies to specific i
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FDA Launches New Adverse Event Look-Up Tool
FDA Launches New Adverse Event Look-Up Tool
http://www.fda.gov/news-events/press-announcements/fda-launches-new-adverse-event-look-tool
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FDA Approves First Treatment for Patients with Cerebral Folate Transport Deficiency
FDA Approves First Treatment for Patients with Cerebral Folate Transport Deficiency
http://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-cerebral-folate-transport-deficiency
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Early Alert: Flexible Cryoprobe Issue from Erbe USA
Erbe Cryoprobes may rupture during activation, leading to potential hearing loss, tinnitus, injury, or burns
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FDA Takes Further Steps to Streamline Biosimilar Development and Make Medicines More Affordable
FDA Takes Further Steps to Streamline Biosimilar Development and Make Medicines More Affordable
http://www.fda.gov/news-events/press-announcements/fda-takes-further-steps-streamline-biosimilar-development-and-make-medicines-more-affordable
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FDA Holds Meeting with States on Importation of Lower Cost Drugs
FDA Holds Meeting with States on Importation of Lower Cost Drugs
http://www.fda.gov/news-events/press-announcements/fda-holds-meeting-states-importation-lower-cost-drugs
