Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 764...
FDA Device Recall #Z-2210-2012 — Class II — May 29, 2012
Recall Summary
| Recall Number | Z-2210-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 29, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Maquet Inc. |
| Location | Wayne, NJ |
| Product Type | Devices |
| Quantity | 20 devices US; 122 devices foreign |
Product Description
Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 [email protected] www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures
Reason for Recall
Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
Distribution Pattern
Worldwide Distribution - USA including MI, MN and Internationally
Lot / Code Information
510k023251 US Catalog Number 161412 Batch Number 92048923 Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578
Other Recalls from Maquet Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0627-2013 | Class II | Maquet Yuno Extension Table Device Maquet GmbH... | Nov 2, 2012 |
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.