Class 2 Device Recall Multifunctional electrode/defibrillation electrode

• Date Initiated by Firm: July 10, 2009
• Date Posted: September 24, 2009
• Recall Status: Terminated on December 17, 2011
• Recall Number: Z-2233-2009
• Recall Event ID: 52794
• 510(K)Number: K072233
• Product Classification: Multifunctional electrodes - Product Code MKJ
• Product: SKINTACT Electrodes for Defibrillation, 10X REF DF20, Rx only, Manufactured by Leonhard Lang GmbH, Archenweg 56, 6020 Innsbruck, Austria. The device is non-sterile and single use. For use on adults and children over eight years old for external defibrillation, pacing, monitoring, and cardioversion.
• Code Information: DF20 SKINTACT Lot #'s 80506-0771, 80527-0776, 80628-0776, 80826-0773, 80911-0773,
• Recalling Firm/ Manufacturer: Leonhard Lang Gmbh; Archenweg 56; Innsbruck Austria
• For Additional Information Contact: 651-439-0400
• Manufacturer Reason for Recall: A potential risk was identified associated with the connectors of the defibrillation electrodes DF20. It was found that some of the connectors do not slip easily into the sockets of the defibrillator or an extension cord of the defibrillator. In such cases increased force or some wiggling is required to insert the connector fully. A potential risk for patients exist, if (a) such a connector (b)
• FDA Determined Cause: Nonconforming Material/Component
• Action: A Leonhard Lang letter dated June 9, 2009 was sent June 6, 2009 to its customer. The letter identified the problem and the product. The letter instructed the consignee to stop using or distributing the product and to quarantine them. It also requested them to report all quantities of product that they had in stock using the attached form.
• Quantity in Commerce: 1433 USA
• Distribution: Worldwide Distribution - US - FL Foreign: Austria, Germany, Romania, France, Dubai, Greece, Italy, South Korea, United Kingdom, Hungary, Latvia, Saudi Arabia and Lebanon
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MKJ