Agency classClass IIOur severity:High FDA (Devices)·Z-0797-2024·Announced 2024-01-31

Bard Nasogastric Sump Tubes Recalled for Reduced Suction and Drainage

C.R. Bard is recalling 26,100 nasogastric sump tubes due to user complaints of inadequate suction and reduced drainage. The malfunction could prevent proper stomach decompression.

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 with user-reported functional malfunction (inadequate suction and drainage) affecting critical patient care. No reported injuries or hospitalizations, but the malfunction creates clear risk of patient harm through aspiration or inability to decompress the stomach, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

C.R. Bard is recalling 26,100 units of the Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit connector (12Fr., 48 inches long). The affected units were distributed in the United States and can be identified by the following lot numbers: NGDT1998, NGDZ3287, NGEU0889, NGEU2134, NGEV2411, NGEW2655, NGEY1506, NGEZ0664, NGFN4265, NGFU4024, NGFV3514, NGFW1857, NGFX0168, NGFX2645, NGGQ8458, NGGR2705, NGGX4777.

The company has received user complaints reporting that these tubes experience inadequate or reduced suction, decompression, and drainage during use. This malfunction prevents proper stomach decompression and creates a risk of aspiration.

Healthcare providers and patients using these tubes should stop use of affected lot numbers and contact C.R. Bard for replacement units and further guidance. Patients should consult with their healthcare provider about appropriate care during the recall period.

The recalled product

Product: Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120
Manufacturer: C.R. Bard Inc
Category: Medical Device — Nasogastric Tubes
Hazard: suction-failure
drainage-failure
aspiration-risk
Affected units: 26,100

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 (18)

UDI/DI 00801741113239
Lot/Serial Numbers: NGDT1998
NGDZ3287
NGEU0889
NGEU2134
NGEV2411
NGEW2655
NGEY1506
NGEZ0664
NGFN4265
NGFU4024
NGFV3514
NGFW1857
NGFX0168
NGFX2645
NGGQ8458
NGGR2705
NGGX4777

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 →

Same manufacturer · C.R. Bard Inc

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Same hazard · suction failure