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Implantable Port Recall: Smiths Medical Removes ProPort Plastic Implantable Ports Due to Manufacturing Error that May Cause Separation

Murilo Freitas - 04:00, 18 de March de 2025203
A manufacturing error may cause ProPort Plastic Implantable Ports, which are used in patients who need repeat venous access for treatment, to separate before, during, or after implantation.

http://www.fda.gov/medical-devices/medical-device-recalls/implantable-port-recall-smiths-medical-removes-proport-plastic-implantable-ports-due-manufacturing

 
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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 2025156
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 2025155
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 2025233
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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