Recall Z-2547-2015— Covidien LLC

Name: FDA recall Z-2547-2015
Creator: U.S. Food and Drug Administration
Published: 2015-08-19

Class II · Terminated

Class II FDA medical device recall by Covidien LLC, initiated 2015-08-19, terminated 2017-05-24. It names one FDA 510(k) clearance: K960329. Product: Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022. Reason: Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns.

Recalling firm: Covidien LLC
Classification: Class II
Status: Terminated
Initiated: 2015-08-19
Terminated: 2017-05-24
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K960329 — DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PADContour Medical Technology, Inc.·cleared 1996-07-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022

Reason for recall

Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns

Data sourced from openFDA. This site is unofficial and independent of the FDA.