Agency classClass IIOur severity:High FDA (Devices)·Z-1356-2018·Announced 2018-04-18

Bard Feeding Tubes Recalled for Ineffective Connector Fusion

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

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 in a medical device used for feeding and medication administration, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

C.R. Bard, Inc. is recalling 3,200 units of Bard Adult/Pediatric Feeding Tubes with ENFit connectors. The recall covers specific lot numbers: NGAY4533, NGAX3534, and NGARX206. These products were distributed nationwide in the United States.

The recall was initiated because the U.S. Food and Drug Administration 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 compatible enteral devices.

These feeding tubes are intended for the decompression of the stomach and the short-term administration of tube feeding, lavage fluid, and medications for neonates, infants, and adults. The source text does not report any specific injuries or illnesses associated with this defect. Consumers and healthcare providers should check their inventory for the affected lot numbers and contact C.R. Bard for further instructions.

The recalled product

Product: 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…
Manufacturer: C.R. Bard, Inc.
Category: Medical Device — Feeding Tubes
Hazard: structural-defect
device-malfunction
Affected units: 3,200

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: NGAY4533
NGAX3534
NGARX206

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 →

Same manufacturer · C.R. Bard, Inc.

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Same hazard · structural defect