***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Ad...
FDA Device Recall #Z-0072-2013 — Class II — September 26, 2012
Recall Summary
| Recall Number | Z-0072-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 26, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MOOG Medical Devices Group |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 12,000 sets |
Product Description
***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
Reason for Recall
This recall is the same issue for the FDA processed recall initiated by Moog Medical Devices on 1/25/11 which was related to customers reporting unclearable Air-In-Line alarm with specific lot numbers of Curlin Administration Sets used with Curlin Ambulatory Infusion Pumps. The lots associated with this recall were inadvertently omitted from the original recall which has since been terminated by
Distribution Pattern
Nationwide Distribution including California
Lot / Code Information
Product Code/Lot Number: 340-4166/CF1022906; 340-4128-V/CRF10082001; 340-4165/CF1022905.
Other Recalls from MOOG Medical Devices Group
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0688-2016 | Class II | Moog Curlin Infusion, Ambulatory Infusion Pump ... | Dec 23, 2015 |
| Z-0415-2016 | Class II | Catalog No. INF0020-A EnteraLite Infinity Ent... | Nov 20, 2015 |
| Z-0294-2013 | Class II | EnteraLite Infinity Enteral Feeding Pump identi... | Nov 8, 2012 |
| Z-0764-2013 | Class II | Infinity Enteralite Ambulatory Feeding Pumps, L... | Oct 12, 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.