MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented ...

FDA Device Recall #Z-0699-2018 — Class II — November 10, 2017

Recall Summary

Recall Number Z-0699-2018
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 2,497/20-administration set cases

Product Description

MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, 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 38148440000495, Lot/serial numbers: CF1518304, CF1521104, CF1524301, CF1523803, CF1528603, and CF1613101.

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-0702-2018 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.