Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Usage: BARD(R) Nasoga...
FDA Device Recall #Z-1356-2018 — Class II — February 27, 2018
Recall Summary
| Recall Number | Z-1356-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 27, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | C.R. Bard, Inc. |
| Location | Covington, GA |
| Product Type | Devices |
| Quantity | 3200 units |
Product Description
Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding Tubes with the ENFit(TM) Connector are made of a smooth plastic with a two-eyed tube used for nasogastric feeding of neonates, infants and adults as well as diagnostic and therapeutic aspiration. These products are sold single-use, sterile. The Feeding Tube with the ENFit(TM) connector provides a way to reduce the risk of enteral device misconnections. The ENFit(TM) connector: Addresses patient side connections between feeding tubes, administration sets, medication, flush and bolus feeding syringes, and other enteral devices. Does not allow connectivity with any other connector for any other clinical use.
Reason for Recall
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
Lot Numbers: NGAY4533, NGAX3534, NGARX206
Other Recalls from C.R. Bard, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1431-2021 | Class II | Bard Clean-Cath Intermittent Catheter, 12 Frenc... | Jan 11, 2021 |
| Z-1354-2018 | Class II | Bard(R) Premature Infant Feeding Tube, ENFit(TM... | Feb 27, 2018 |
| Z-1357-2018 | Class II | Bard(R) Premature Infant Feeding tube, ENFit(TM... | Feb 27, 2018 |
| Z-1355-2018 | Class II | Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0... | Feb 27, 2018 |
| Z-2064-2018 | Class II | Bardex Lubricath 3-Way 75cc Continuous Irrigati... | Dec 13, 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.