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Terminated

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

FDA Recall Z-2547-2015 · Posted 2015-09-02

Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeMKJ
Date Initiated2015-08-19
Date Terminated2017-05-24
Product Quantity56,000 sets

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

Firm Action

Medtonic/Covidien issued recall letter on August 19, 2015. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 2 Ludlow Park Drive, Chicopee, MA 01022, Attention: Field Action Returns. Contact your Medtronic representative or Customer Service at (800)-882-5878.

Root Cause

Process control

Distribution Pattern

Nationwide Foreign: Canada Australia Denmark Germany New Zealand

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K960329DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PADContour Medical Technology, Inc. · 1996-07-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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