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.
FDA Recall Z-2233-2009 · Posted 2009-09-24
Advertisement
Recalling FirmLeonhard Lang Gmbh
Recall StatusTerminated
Product CodeMKJ
Date Initiated2009-07-10
Date Terminated2011-12-17
Product Quantity1433 USA
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)
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - US - FL Foreign: Austria, Germany, Romania, France, Dubai, Greece, Italy, South Korea, United Kingdom, Hungary, Latvia, Saudi Arabia and Lebanon
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement