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As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.
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Smiths Medical Issues Urgent Medical Device Correction Informing Customers of a Potential Issue with Certain Sizes of Intubation ORAL/NASAL Endotracheal Tubes Being Smaller Than Expected
Smiths Medical has issued an Urgent Medical Device Correction to notify affected global customers of a potential issue with the 2.0, 2.5, 3.0 and 3.5 mm sizes of Intubation ORAL/NASAL Endotracheal Tube products being smaller than expected.
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FDA Roundup: March 7, 2025
FDA Roundup: March 7, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-march-7-2025
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Update on Alert: Fluid Delivery Set Issue from Medline
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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Early Alert: Infusion Pump Issue from Baxter Healthcare Corporation
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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Update on Alert: Solution Set Issue from Baxter Healthcare Corporation
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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Update on Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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Update on Alert: Nephroscope Sheath Issue from Trokamed GmbH
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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Update on Alert: Extracorporeal Blood Circuit Issue from Nuwellis
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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FDA Roundup: March 4, 2025
FDA Roundup: March 4, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-march-4-2025