CLASS II Device recall · Reported 18 Apr 2018 · FDA Enforcement Report
Bard(R) Premature Infant Feeding tube, ENFit(TM) recalled by C.R. Bard
C.R. Bard is recalling Bard(R) Premature Infant Feeding tube, ENFit(TM), distributed nationwide in the US. The recall was initiated on 27 Feb 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1357-2018
- FDA event ID
- 79507
- Recalling firm
- C.R. Bard, Covington, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Feb 2018
- FDA classified
- 10 Apr 2018
- Reported
- 18 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Infusion Pumps
Timeline
| 27 Feb 2018 | Recall initiated by company | |
| 10 Apr 2018 | Classified by FDA | +42 days |
| 18 Apr 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
Which lots are affected?
Lot Numbers: NGBN2862, NGAXX217, NGAVX225
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 79507| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM) recalled by C.R. Bard | C.R. Bard | Foreign Material | Nationwide | |
| CLASS II | Bard(R) Infant Feeding Tube, ENFit(TM) recalled by C.R. Bard | C.R. Bard | Foreign Material | Nationwide | |
| CLASS II | Bard(R) Premature Infant Feeding Tube, ENFit(TM) recalled by C.R. Bard | C.R. Bard | Foreign Material | Nationwide |
More recalls from C.R. Bard
All 123| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Temperature Abuse | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Temperature Abuse | Nationwide |
Other Infusion Pumps recalls
All 546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |