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Use of Baxter MiniCap Extended Life PD Transfer Sets during peritoneal dialysis may expose patients to higher than allowable NDL-PCBAs.
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FDA Roundup: November 26, 2024
FDA Roundup: November 26, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-november-26-2024
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FDA Roundup: November 22, 2024
FDA Roundup: November 22, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-november-22-2024
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Mxbbb Issues Voluntary Nationwide Recall of Umary Acid Hyaluronic Due to the Presence of Diclofenac and Omeprazole
MXBBB is voluntarily recalling 1 lot of UMARY ACID HYALURONIC, 30 CAPLETS 850 MG to the consumer level. The products have been found to have omeprazole and diclofenac. FDA laboratory analysis confirmed that Umary contains diclofenac and omeprazole
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FDA Roundup: November 19, 2024
FDA Roundup: November 19, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-november-19-2024
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Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling
Endo USA, Inc. is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling.
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Battery Pack Correction: Smiths Medical Updates Use Instructions for CADD-Solis Li-ion Rechargeable Battery Packs Due to Risk That Pack Damage May Cause a Circuit Short and Prevent Recharge
Battery casing damage on CADD-Solis battery packs, which provide alternate power to infusion pumps, may cause a circuit short and prevent recharging.
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Ventilator Correction: Philips Updates Use Instructions for Trilogy Evo, EvoO2, EV300, Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2 due to Risk of Inaccurate Flow Measurements Caused By Certain In-Line Nebulizer Placements
Inline nebulizers in certain configutations on Trilogy Evo continuous ventilators may lead to inaccurate flow measurements which may cause patient injury.
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FDA Roundup: November 15, 2024
FDA Roundup: November 15, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-november-15-2024
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Endoscopic Vessel Harvesting System Recall: Getinge and Maquet Cardiovascular Remove VasoView HemoPro 1 and 1.5 Endoscopic Vessel
HemoPro EVH Systems are being recalled due to a risk for silicone to detach from the device and enter the patient during minimally invasive surgery.