Z-2547-2015Class II

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

Name: Z-2547-2015 Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak Preconnect System Item Code:PM20022
Creator: Covidien LLC
Published: 2015-08-19
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-08-19 / Terminated / root cause: manufacturing process

FDA source

Covidien LLC began a recall of Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak Preconnect System Item Code:PM20022 on 2015-08-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2547-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-19
Posted: 2015-09-02
Terminated: 2017-05-24
Recalling firm: Medtronic, Inc.
Product: Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak Preconnect System Item Code:PM20022
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 56,000 sets
Distribution: Nationwide Foreign: Canada Australia Denmark Germany New Zealand
Product codes and lots: Lot Numbers: 516907, 519815, 519816

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2547-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2545-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02
Z-2546-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02
Z-2547-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02

Product code MKJ

K960329Class IIIDisposable Hydrogel Defibrillation Electrode/padContour Medical Technology, Inc. / cleared 1996-07-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)