The Food and Drug Administration (FDA) has alerted providers and other users to a recall of Leonhard Lang Skintact brand DF29N multi-function electrodes due to problems connecting the electrodes to certain automatic external defibrillators (AEDs).
According to FDA, the Skintact defibrillation electrodes might not connect properly to Welch Allyn model 10 AEDs, delaying electrical therapy and potentially resulting in serious patient harm.
The recall affects defibrillation electrodes distributed between Feb. 14, 2014, and Aug. 3, 2016. In September, the company sent a safety notice to all affected customers instructing them to:
- secure and destroy all unused DF29N defibrillation electrodes;
- notify their supplier that the unused products were destroyed by Oct. 14; and
- retain the notification form until the recall has ended.
FDA advises health care professionals to report adverse events or side effects related to the electrodes to the agency’s MedWatch Safety Information and Adverse Event Reporting Program. Questions about the recall should be directed to the Leonhard Lang sales office, at 800.903.6199.