—#139672

Product

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

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K960329
Affected lot / code info: Lot Numbers: 516907, 519815, 519816

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern: Nationwide Foreign: Canada Australia Denmark Germany New Zealand

Timeline

Recall initiated: 2015-08-19
Posted by FDA: 2015-09-02
Terminated: 2017-05-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139672. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.