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.