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Embolization Device Recall and Correction: Medtronic Removes Unused 027 Compatible Pipeline Vantage Embolization Device with Shield Technology, Updates Use Instructions for 021 Compatible Pipeline Vantage Embolization Devices due to Increased Risk of Incomplete Wall Apposition and Braid Deformation

Murilo Freitas - 04:00, 17 de March de 2025135
Pipeline Vantage Embolization Devices block off blood flow to intracranial aneurysms. Some devices do not attach properly or fail to stay attached.

http://www.fda.gov/medical-devices/medical-device-recalls/embolization-device-recall-and-correction-medtronic-removes-unused-027-compatible-pipeline-vantage

 
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Disruptions in Availability of Hemodialysis Bloodlines – Letter to Health Care Providers

Murilo Freitas - 04:00, 13 de March de 2025137
The FDA is adding hemodialysis bloodlines (also referred to as set, tubing, blood, with and without anti-regurgitation valve; product code FJK) to the Medical Device Shortage List because of recent supplier issues.

http://www.fda.gov/medical-devices/letters-health-care-providers/disruptions-availability-hemodialysis-bloodlines-letter-health-care-providers

 
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Dr. Reddy’s Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., Due to Mislabeling of Infusion Bag

Murilo Freitas - 20:00, 12 de March de 2025206
Dr. Reddy’s Laboratories Ltd is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags to the consumer level, in the United States.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-issues-nationwide-recall-levetiracetam-075-sodium-chloride-injection-1000-mg100-ml-us-due

 
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Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC): Voluntary Lot Withdrawals – Due to Increased Reports of Allergic/Hypersensitivity Reactions

Murilo Freitas - 04:00, 10 de March de 2025141
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the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.

http://www.fda.gov/safety/medical-product-safety-information/immune-globulin-intravenous-igiv-and-immune-globulin-subcutaneous-igsc-voluntary-lot-withdrawals-due

 
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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

Murilo Freitas - 04:00, 9 de March de 2025167
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.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/smiths-medical-issues-urgent-medical-device-correction-informing-customers-potential-issue-certain

 
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