The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Recalled Product: Defibrillation Electrode SKINTACT DF59N and Defibrillation Electrode SKINTACT DF59NC
- Lot Numbers:
- DF59N: 41029-0770, 41219-0778, and 50403-0772
- DF59NC: 40906-0972, 41203-0973, 50116-0975, 50211-0974, 50402-0974, and 50527-0974
- Distribution Dates: September 5, 2014 to May 28, 2017
- Manufacturing Dates: September 4, 2014 to May 21, 2015
- Devices Recalled in the U.S.: 541 nationwide
Automatic external defibrillators (AEDs) are used to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Defibrillation electrodes are connected to the AED to help the device analyze a patient's heart rhythm and deliver an electrical shock to restore normal heart rhythm when needed. The primary users of AEDs are first responders and hospital health care providers.
Reason for Recall
Leonhard Lang is recalling the Skintact multifunction defibrillation electrode models DF59N and DF59NC due to a connector compatibility issue with the ZOLL AED Plus. The user may not be able to connect the electrodes to the defibrillator. This may result in a defibrillation shock being delayed or not delivered at all.
The delay or inability to deliver a shock to a patient in cardiac arrest could result in serious injury and/or death.
Who May be Affected
- Health care providers and first responders using this defibrillation electrode.
- Patients who may need this defibrillation electrode to restore normal heart rhythm.
What to Do
On August 8, 2017, Leonhard Lang sent an Important Safety Notification notice to all affected customers. The notice asked distributors and customers to:
- Review the safety notice and ensure appropriate staff is aware of the notice.
- Quarantine all affected products in stock.
- Contact Leonhard Lang and coordinate the required quantity of replacement electrodes immediately. As soon as the replacement electrodes are received, destroy all affected products in stock.
- Complete and return Safety Notification and Immediate Actions” form to Leonhard Lang no later than August 25, 2017.
- If none of the affected products were distributed, no other actions are required.
- If any of the affected products were distributed to customers, take the following actions:
- Forward a copy of the Important Safety Notification, Safety Notification and Immediate Actions, and Customers' Responses Summary forms to the affected customers.
- For each lot number, add up all affected customers' responses from the returned Safety Notification and Immediate Actions and Customers' Responses Summary forms, and enter the totals in the table of form Customers' Responses Summary. The totals should add up to the number of affected products shipped to the customers.
- Sign the completed Customers' Responses Summary form and return it to Leonhard Lang no later than October 27, 2017.
Leonhard Lang GmbH
Attn. Daniela Lörgetbohrer
Archenweg 56, Austria
Phone: +43 (0)512 33425-58
Fax: +43 (0)512 392210
Customers are instructed to contact Leonhard Lang sales staff at (800) 903-6199 with any questions related to this recall.
Date Recall Initiated
August 17, 2017
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.