It has come to our attention that medical device manufacturer, Ethicon, has initiated a field safety corrective action concerning its Temporary Cardiac Pacing Wire. The affected product codes are FEP13E and FEP15E.
The manufacturer has initiated a recall for 20 lots of Temporary Cardiac Pacing Wire with the above product codes due to the potential for a loose connection between the wire and straight needle, which may impact conductivity and functionality of the device. The issue was identified internally during routine quality control testing.
The manufacturer advises users to quarantine and return the affected products.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 14 June 2013