Agency classClass IIOur severity:High FDA (Devices)·Z-0800-2024·Announced 2024-01-31

Bard Nasogastric Sump Tube Recalled for Reduced Suction and Drainage

C.R. Bard is recalling Bard Nasogastric Sump Tubes due to reports of inadequate or reduced suction, decompression, and drainage during use. The recall affects 57,159 units distributed in the United States.

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 reported functional failure (reduced suction and decompression) but no reported hospitalizations or injuries. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, meeting the High severity threshold.

Plain-English summary

C.R. Bard Inc. is recalling Bard Nasogastric Sump Tubes with PreVent Anti-Reflux Filter and ENFit Connectors (18 French, 48 inches long, REF EN0046180). The recall affects 57,159 units distributed in the United States. Affected units can be identified by the UDI/DI 00801741113260 or by checking the lot number.

The recall was initiated following user reports that the tubes experienced inadequate or reduced suction, decompression, and drainage during use. These devices are designed to provide gastric decompression and drainage, and reduced functionality could affect their clinical performance.

Healthcare providers and facilities using these tubes should verify whether they have affected units by checking lot numbers and the UDI. Affected units should be discontinued from use, and facilities should contact C.R. Bard for information about replacements and further guidance.

The recalled product

Product: Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180
Manufacturer: C.R. Bard Inc
Category: Medical Device — Nasogastric Tubes
Hazard: device-malfunction
reduced-suction
Affected units: 57,159

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 (20)

UDI/DI 00801741113260
Lot/Serial Numbers: NGDT2000
NGDX0518
NGEW1822
NGEW3855
NGEX0043
NGEX1998
NGEZ2693
NGFP0406
NGFP3519
NGFR0244
NGFT0418
NGFT3481
NGFU3821
NGFV0785
NGFV1654
NGFV3445
NGFW1906
NGFX0169
NGFX2674

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 · device malfunction