FDA Medical Device Recalls (openFDA)
Covidien LLC: Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak Preconnect System Item Code:PM20022
- Recall number
- Z-2547-2015
- Recalling firm
- Covidien LLC
- Product
- Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak Preconnect System Item Code:PM20022
- Status
- Terminated
- Initiated
- 2015-08-19
- Posted
- 2015-09-02
- Terminated
- 2017-05-24
- 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
- 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
- 56,000 sets
- Distribution
- Nationwide Foreign: Canada Australia Denmark Germany New Zealand
- Lot, serial or model codes
- Lot Numbers: 516907, 519815, 519816
- 510(k) numbers
- ["K960329"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28