MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented ...
FDA Device Recall #Z-0702-2018 — Class II — November 10, 2017
Recall Summary
| Recall Number | Z-0702-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 10, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zevex Incorporated (dba Moog Medical Medical Devices Group) |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 785/20-administration set cases |
Product Description
MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless Injection Port (Positive Pressure), Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
Reason for Recall
Particulate found on the Curlin spike.
Distribution Pattern
Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia.
Lot / Code Information
UDI 38148440000594, Lot/serial numbers: CF1520208, CF1522301, and CF1532971.
Other Recalls from Zevex Incorporated (dba Moog Medical ...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0698-2018 | Class II | MOOG Curlin Infusion Administration Set, Ref 34... | Nov 10, 2017 |
| Z-0699-2018 | Class II | MOOG Curlin Infusion Administration Set, Ref 34... | Nov 10, 2017 |
| Z-0700-2018 | Class II | MOOG Curlin Infusion Administration Set, Ref 34... | Nov 10, 2017 |
| Z-0701-2018 | Class II | MOOG Curlin Infusion Administration Set, Ref 34... | Nov 10, 2017 |
| Z-0697-2018 | Class II | MOOG Curlin Infusion Administration Set, Ref 34... | Nov 10, 2017 |
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.