Teleflex—WECK EFX Endo Fascial Closure Systems: Wings May Become Partially Detached from EFx Shield during Use
November 30, 2016 | Risk Management News
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In a November 16, 2016, Urgent Medical Device Recall Notification letter submitted by an ECRI Institute member hospital, Teleflex states that it has received reports of the wings of the above systems becoming partially detached from the EFx shield during use. Teleflex also states that the wings are secured to the device at 2 points; therefore, in the reported instances they did not completely detach from the device. Teleflex further states that the partial detachment makes removal of the device from the patient more difficult and that the incision site may need to be enlarged to remove the device. Teleflex states that it has received no...