Z-2547-2015 Class II Terminated
FDA device recall Z-2547-2015 was initiated by Covidien LLC on Aug 19, 2015 and is designated Class II. 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… The recall status is terminated (terminated May 24, 2017). Affected quantity: 56,000 sets.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 9, 2015
- Initiation Date
- Aug 19, 2015
- Termination Date
- May 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56,000 sets
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
Distribution Pattern
Nationwide Foreign: Canada Australia Denmark Germany New Zealand
Code Information
Lot Numbers: 516907, 519815, 519816
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2547-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026