Agency classClass IIOur severity:High FDA (Devices)·Z-0803-2024·Announced 2024-01-31

Bard Nasogastric Sump Tube Recalled Due to Reduced Suction and Drainage

C.R. Bard is recalling 3,650 units of Bard Nasogastric Sump Tubes with ENFit connectors due to user complaints of inadequate suction, decompression, and drainage during use. The issue could affect proper tube function in clinical settings.

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 without reported hospitalizations or injuries. The reduced suction and decompression function represents a risk-of-harm scenario where injury has not yet been reported, meeting the High severity criterion.

Plain-English summary

C.R. Bard, Inc. is recalling 3,650 units of the Bard Nasogastric Sump Tube with PreVent Filter and Lopez Valve with ENFit connector (14 French, 48 inches long, model EN0056140). Affected lot numbers are NGEX0090, NGEX1982, NGEZ2116, NGGP3242, NGHQ1395, and NGHQ1411.

The recall was initiated following user complaints that during use, these tubes exhibited inadequate or reduced suction, decompression, and drainage. These functions are essential for proper tube operation in clinical settings.

The recalled tubes were distributed in the United States.

The recalled product

Product: Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140
Manufacturer: C.R. Bard Inc
Category: Medical Device — Nasogastric Tube
Hazard: device-malfunction
suction-failure
Affected units: 3,650

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 (7)

UDI/DI 00801741113857
Lot/Serial Numbers: NGEX0090
NGEX1982
NGEZ2116
NGGP3242
NGHQ1395
NGHQ1411

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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