Medical device manufacturer, CooperSurgical, has issued a field safety notice concerning its Radius Loop Electrode Box of 5. The affected part number is R2010 and lot number is 159621.
The product may have been packaged with an incorrectly labeled package type (Radius Loop Electrode P/N R1010). The affected product is a single-use sterile disposable device. The product package contains 5 individually sealed pouches consisting of clear plastic front and a Tyvek lid back. The device lot number and expiration date is located on the Tyvek lid as well as on the side of the external packaging.
According to the manufacturer's health hazard evaluation report, the potential hazard situation associated with the nonconformance is minimal and no adverse events or injuries have been reported to date in connection with the use of the affected product.
The manufacturer advises customers to return the affected products to them and product replacement can be arranged.
According to the manufacturer, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 October 2014