Medical Device Recalls
A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. Medical device recalls don't always involve a stop of use of a certain product many times the device needs to be checked, adjusted or fixed. Often when a device has a potential for failure doctors are advised to contact patients and discuss the risks associated with removal or continued use of the product.
A recall is either a correction or a removal depending on where the action takes place. A correction addresses a problem with a medical device in the place where it is used or sold. While a removal addresses a problem with a medical device by removing it from where it is used or sold.
Who Recalls The Device
Usually a company or manufacturer, distributor or other responsible party recalls a device voluntarily. When a company learns a product has violated FDA law it does two things, recalls the device and notifies the FDA. The FDA legally can require a company to recall a device. This usually happens when the company refuses to recall a device that is associated with significant health problems or death.
December 01, 2011
Cooper Vison Avaira Toric Soft Contact Lenses Recalled
Cooper Vison the maker of the Avaira Toric soft contact lens is recalling lenses made from November 01, 2010 to August 3, 2011. Over 778,000 lens were distributed. The reason for the recall is the unintended presence of silicone oil residue on the lenses. The continued use of the lenses can cause hazy, blurry vision and damage to the eye, which may result in medical treatment. The recall was initiated on August 19, 2011.
September 12, 2011
CareFusion EnVe Ventilators Recalled
The CareFusion EnVe Ventilator is a portable ventilator used in providing breathing assistance to pediatric and adult patients in hospitals and medical transport. The device is being recalled due to potential defects associated with model 19250-001 that could interrupt ventilation to the patient.
Any delay in receieving ventilation could lead to hypoxia or bypercarbia which may result in serious brain damage or death. The Recall was issued on September 12, 2011. The affected products were manufactured between December 2010 and May 2011.