The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1357-2018·Announced 2018-04-18

Bard Premature Infant Feeding Tubes Recalled for Ineffective Fusion

C.R. Bard is recalling specific lots of Bard Premature Infant Feeding Tubes because the tubing and ENFit connector may not be effectively fused.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect (ineffective fusion) in a medical device used for infant feeding, which poses a risk of harm, but the source text does not report specific injuries or illnesses.

Plain-English summary

C.R. Bard, Inc. is recalling 4,800 units of Bard Premature Infant Feeding tubes, ENFit, REF EN0036430. The affected lots are NGBN2862, NGAXX217, and NGAVX225. These products were distributed nationwide in the United States.

The U.S. Food and Drug Administration (FDA) identified that the product code and lot number combination may have ineffectively fused tubing and ENFit connector. The ENFit connector is designed to reduce the risk of enteral device misconnections by only allowing connectivity with specific compatible devices.

This recall is classified as Class II by the FDA. Consumers and healthcare providers should stop using the affected products and contact C.R. Bard, Inc. for instructions on how to return or dispose of the devices.

The recalled product

Product
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…
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Feeding Tubes
Hazard
Affected units
4,800

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot Numbers: NGBN2862
  • NGAXX217
  • NGAVX225

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by C.R. Bard, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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