QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADRO...
FDA Device Recall #Z-2262-2013 — Class II — August 15, 2013
Recall Summary
| Recall Number | Z-2262-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 15, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Maquet Cardiovascular Us Sales, Llc |
| Location | Wayne, NJ |
| Product Type | Devices |
| Quantity | 1,182 units |
Product Description
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Reason for Recall
The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.
Distribution Pattern
Worldwide Distribution, including Nationwide (US) and foreign countries.
Lot / Code Information
QUADROX-iD Adult catalog number HMOD 70000, lot # 70081567 QUADROX-i Adult catalog number VKMO 70000, lot # 70082663 QUADROX-i Adult catalog number VKMO 71000, lot # 70083974
Other Recalls from Maquet Cardiovascular Us Sales, Llc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0632-2021 | Class II | HLS Set Advanced Model Name: BEQ-HLS 5050 USA; ... | Nov 20, 2020 |
| Z-0633-2021 | Class II | HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS ... | Nov 20, 2020 |
| Z-0443-2021 | Class II | Blood Monitoring Unit (BMU 40), model no. 70104... | Sep 30, 2020 |
| Z-0133-2021 | Class II | Yuno II Mobile Operating Table - Product Usage:... | Sep 24, 2020 |
| Z-0132-2021 | Class II | Yuno Mobile Operating Table - Product Usage: In... | Sep 24, 2020 |
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.