Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 7010560...
FDA Device Recall #Z-2179-2018 — Class II — July 27, 2017
Recall Summary
| Recall Number | Z-2179-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 27, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Datascope Corporation |
| Location | Fairfield, NJ |
| Product Type | Devices |
| Quantity | 27 |
Product Description
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.
Reason for Recall
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Distribution Pattern
The products were distributed to the following US states: IA and FL.
Lot / Code Information
UDI 0607567203600
Other Recalls from Datascope Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0131-2023 | Class II | LINEAR 7.5Fr. 40cc IAB with Accessories (APA), ... | Aug 5, 2022 |
| Z-1687-2022 | Class II | Insertion Kit for use with SENSATION PLUS 8F. 5... | Aug 5, 2022 |
| Z-1686-2022 | Class II | Sensation Plus 8Fr 50cc Intra-Aortic Balloon Ca... | Aug 5, 2022 |
| Z-1685-2022 | Class II | MEGA 8Fr 50cc Intra-Aortic Balloon Catheter | Aug 5, 2022 |
| Z-2839-2020 | Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-... | Jul 27, 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.