Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its 27mm Masters Mitral Standard Polyester Cuff Mechanical Heart Valve [Model# 27MJ-501/ Part# 100085349; GTIN: 05414734006460]
The manufacturer has identified that the products distributed between March 2020 and September 2021 were packaged with incorrect addendum Portuguese labels and an incorrect addendum Portuguese IFU. According to the manufacturer, the selection of the affected product has the potential to cause a prolonged procedure, as well as incorrect registration and medical record charting if used.
The manufacturer advised affected users to identify, quarantine and return the affected products. For those patients who have already been implanted with one of the affected valves, it is recommended that the product registration and medical record be updated to reflect the correct model number and product description.
According to the local supplier, the affected product is not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 Oct 2021