Important Safety Alerts

Medical device manufacturer, Leonhard Lang GmbH, has issued a medical device safety alert concerning its following products:

• Product: A) Multifunction Electrodes, compatible with MEDUCORE Standard, for adults; B) Multifunction Electrodes, compatible with MEDUCORE Standard and MEDUCORE Easy, for adults; C) Defibrillation electrode Mindray
• Reference Number: A) WM 45418; B) WM 40116; C) MR62
• Lot Number: A) 180104-0971, 180118-0970, 180314-0973, 190225-4019; B) 60519-0971, 171113-0971, 60905-0976, 171114-0972, 161212-0970, 180314-0972, 170425-0978, 180622-0979, 170703-0974, 181024-0975, 171006-0979, 190125-0970; C) 170614-0970, 170810-0973, 170911-0974, 180420-0974, 180615-0975, 180829-0971, 181113-0974, 190226-4016, 190227-4017

According to the manufacturer, electrode material may be trapped between the eyelet of the cable and the rivet in the affected electrodes. There is a possibility that an ECG can neither be recorded nor can energy be delivered by the electrode pair. This may mean that timely treatment of a patient in a life-threatening condition who requires a defibrillation shock is not possible.

Users are advised to leave the electrodes with the devices until they are provided with a replacement electrode. If users are in possession of additional electrodes, ensure that a second additional replacement electrode is carried with each device or is enclosed with the device. Users are advised to use this replacement electrode if they encounter a faulty electrode during use.

Product replacement is on-going.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 16 May 2019