Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use o...
FDA Device Recall #Z-2517-2020 — Class II — January 17, 2020
Recall Summary
| Recall Number | Z-2517-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 17, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Kentec Medical, Inc |
| Location | Irvine, CA |
| Product Type | Devices |
| Quantity | 2130 |
Product Description
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-80P-50 (8 fr. 50 cm ENFit Enteral Feeding Tube).
Reason for Recall
Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Distribution Pattern
US: CA, IA, and VA
Lot / Code Information
Lot Number: KS1904004
Other Recalls from Kentec Medical, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2518-2020 | Class II | Ameritus Medical Products ENFit Polyurethane an... | Jan 17, 2020 |
| Z-2514-2020 | Class II | Ameritus Medical Products ENFit Polyurethane an... | Jan 17, 2020 |
| Z-2515-2020 | Class II | Ameritus Medical Products ENFit Polyurethane an... | Jan 17, 2020 |
| Z-2519-2020 | Class II | Ameritus Medical Products ENFit Polyurethane an... | Jan 17, 2020 |
| Z-2520-2020 | Class II | Ameritus Medical Products ENFit Polyurethane an... | Jan 17, 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.