Agency classClass IIOur severity:High FDA (Devices)·Z-0802-2024·Announced 2024-01-31

Bard Nasogastric Sump Tube Recalled for Inadequate Drainage

C.R. Bard is recalling 3,360 units of Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction 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 recall for a medical device with functional failure and no reported hospitalizations or injuries. The hazard—inadequate drainage and decompression—poses potential risk of harm to patients, meeting the High severity threshold for risk-of-harm products where injury has not yet been reported.

Plain-English summary

C.R. Bard Inc is recalling 3,360 units of the Bard Nasogastric Sump Tube and PreVent Anti-Reflux Filter with Lopez Valve, 12Fr., 48 inches long (UDI/DI 00801741113840, Lot/Serial Numbers NGDU4228 and NGGR2707). The recall applies to units distributed in the United States.

The company has received user complaints reporting that during use of these nasogastric sump tubes with ENFit connectors, inadequate or reduced suction, decompression, and drainage occurred. This functional failure prevents the tubes from performing their intended purpose of removing gastric contents.

Patients or healthcare providers who have used or are using this product should contact C.R. Bard Inc immediately. Do not use affected lots and consult with your healthcare provider if there are concerns about patient care.

The recalled product

Product: Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 12Fr., 48in Long, REF EN0056120
Manufacturer: C.R. Bard Inc
Category: Medical Device — Nasogastric drainage tube
Hazard: device-malfunction
drainage-failure
reduced-suction
Affected units: 3,360

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)

UDI/DI 00801741113840
Lot/Serial Numbers: NGDU4228
NGGR2707

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 · device malfunction