Recommended not to use it and return it to the supplier
The Ministry of Health warns of a medical method that “may cause a clot”
The Ministry of Health has lifted the suspension of the registration of a new medicinal product.
Emirates today
The Ministry of Health and Community Protection has warned against a medical method, the use of which may result in clots and circulatory disorders.
Recommended not to use it, and return it to the supplier.
In circulating his directive to health facilities and health care practitioners, it indicated that all batches of the Venovo™ Venous Stent System, which is used to deliver a self-expanding stent to the venous blood vessels, should be prohibited from using to treat the symptoms of venous outflow obstruction.
The ministry stated that the manufacturer withdrew the batches from the device, due to a manufacturing problem that leads to the failure to expand the proximal end of the stent, as the end of the stent remains connected to the stent cushion in the delivery system, which may cause injuries that include prolonging the surgical process, damaging or deforming the stent, and disorders in Circulation affects blood flow and clot formation. In a second circular, the ministry decided to lift the suspension of the registration of the medicinal product Omeprex (Omeprazole) 20mg Capsules, after the manufacturer demonstrated the quality and efficacy of the product by submitting a bioequivalence study to it, and the Saudi Food and Drug Authority lifted the suspension on its registration. In a third circular, the ministry warned against the medical product BD Venflon Pro safety and Venflon Pro IV cannula, after the manufacturer recalled sterile ethylene oxide products EtO, due to increased reports of leakage from the injection port of sterile devices, but it does not affect sterile products by electron beam.
The ministry recommended making sure that there are appropriate medical means, and ensuring that there is an adequate supply of the means, to maintain the provision of appropriate health care, with the need to return the affected operations to the supplier.
In a fourth circular, the ministry warned of a number of applications for the medical device, A Li-Gator Single Use Laparoscopic Clip Applier, due to the failure of its work.
The prohibited methods included Model: 360-010-001Codes: 8250 I8251 I8252 I8820 I8821 I8822 I8823 I8824 I8825 I9571-A I9572-A I9573-A I9716-A I9717-A I9718-A I9719-A J0113-A J0114-A J0115- A J0225-A J0227-A J0228-A J0229-A J0230-A J0231-A J0240-A J0243-A J0287-A».
The ministry asked to communicate with the manufacturer to replace the product, at no additional cost.
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