Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item ...
FDA Device Recall #Z-2547-2015 — Class II — August 19, 2015
Recall Summary
| Recall Number | Z-2547-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 19, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Covidien LLC |
| Location | North Haven, CT |
| Product Type | Devices |
| 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
Lot / Code Information
Lot Numbers: 516907, 519815, 519816
Other Recalls from Covidien LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1557-2026 | Class II | HealthCast "Vital Sync" Remote Patient Monitori... | Jan 30, 2026 |
| Z-1775-2022 | Class II | Puritan Bennett 560 Ventilator, PB560, CFN 4096600 | Aug 19, 2022 |
| Z-1318-2022 | Class I | Palindrome SI Chronic Catheter, Sterile, Single... | Jun 8, 2022 |
| Z-1319-2022 | Class I | Palindrome HSI Chronic Catheter, Sterile, Singl... | Jun 8, 2022 |
| Z-1315-2022 | Class I | Palindrome Precision HSI Chronic Catheter, Ster... | Jun 8, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.