Presource PBDS, Extremity, Kit, Circulator
FDA Device Recall #Z-1198-2013 — Class I — March 26, 2013
Recall Summary
| Recall Number | Z-1198-2013 |
| Classification | Class I — Serious risk |
| Date Initiated | March 26, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cardinal Health, Medical Products & Services |
| Location | Park City, IL |
| Product Type | Devices |
| Quantity | 4,571 Kits total |
Product Description
Presource PBDS, Extremity, Kit, Circulator
Reason for Recall
Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Distribution Pattern
Distributed in the states of AR, MS, SC, and TN.
Lot / Code Information
Catalog Number: PO24EXNPD01; Lots: 852429, 868825, 883022, 896400, 914524, 929984, 941696, 954317
Other Recalls from Cardinal Health, Medical Products & S...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1206-2013 | Class I | Presource PBDS, Knee Arthroscopy, Kit, Circulator | Mar 26, 2013 |
| Z-1203-2013 | Class I | Presource PBDS, Total Joint, Kit, Circulator | Mar 26, 2013 |
| Z-1196-2013 | Class I | Presource PBDS, Major Abdominal, Kit, Circulator | Mar 26, 2013 |
| Z-1204-2013 | Class I | Presource PBDS, Total Knee, Kit, Circulator | Mar 26, 2013 |
| Z-1202-2013 | Class I | Presource PBDS, Total Hip, Kit, Circulator | Mar 26, 2013 |
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.