Agency classClass IIOur severity:High FDA (Devices)·Z-0794-2024·Announced 2024-01-31

Bard Nasogastric Sump Tubes recalled due to inadequate suction and drainage

C.R. Bard is recalling 37,059 units of Bard Nasogastric Sump Tubes with ENFit due to user reports of inadequate suction, decompression, and drainage during use.

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: FDA Class II medical device recall for functional failure affecting critical care functions (suction and drainage). This is a risk-of-harm product with no reported hospitalizations or injuries mentioned in the source, meeting the High severity criterion.

Plain-English summary

C.R. Bard, Inc. is recalling 37,059 units of Bard Nasogastric Sump Tubes with ENFit (18 French, 48 inches long) due to user complaints of inadequate or reduced suction, decompression, and drainage during use.

The affected product has specific lot numbers: NGDT1997, NGES3427, NGES4095, NGFV0834, NGFV3461, NGFW1886, NGFX5524, NGFY2527, and NGGT3565 (UDI/Device Identifier 00801741113819). These units were distributed in the United States.

Healthcare facilities and individuals should check their inventory against the listed lot numbers. Any units matching these affected lots should be removed from use immediately. Those experiencing inadequate suction, decompression, or drainage should report the issue to the FDA and contact the manufacturer.

The recalled product

Product: Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180
Manufacturer: C.R. Bard Inc
Category: Medical Device — Nasogastric Tube
Hazard: suction-failure
drainage-failure
Affected units: 37,059

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 (10)

UDI/DI 00801741113819
Lot/Serial Numbers: NGDT1997
NGES3427
NGES4095
NGFV0834
NGFV3461
NGFW1886
NGFX5524
NGFY2527
NGGT3565

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 17 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 17 products in this recall →

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Same hazard · suction failure