Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-3109-2017 — Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrillators

U.S. FDA — Device Enforcement · Austria · 2017-08-08 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3109-2017
Date of alert
2017-08-08
Country / jurisdiction
Austria
Risk level
Class I
Risk type
recall
Brand
Leonhard Lang Medizintechnik GmbH
Product category
device
Product type
Devices
Reported risk: Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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