Agency classClass IIOur severity:High FDA (Devices)·Z-0799-2024·Announced 2024-01-31

Bard Nasogastric Sump Tube Recalled for Reduced Suction and Drainage

C.R. Bard is recalling 51,750 Bard Nasogastric Sump Tubes with PreVent Anti-Reflux Filter due to reports of inadequate 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 classification without reported hospitalizations or injuries. The product failure (inadequate suction and drainage) poses a potential risk of harm to patients requiring nasogastric tube use, fitting the criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

C.R. Bard Inc. is recalling 51,750 units of Bard® Nasogastric Sump Tubes with PreVent® Anti-Reflux Filter with ENFit, 16Fr., 48 inches long (REF EN0046160). The FDA classified this as a Class II recall. User complaints reported that during use, these tubes exhibited inadequate or reduced suction, decompression, and drainage.

The affected product was distributed in the United States. Affected units can be identified using UDI/DI 00801741113253 and specific lot numbers including NGDX0520, NGES3426, NGET0807, NGET1424, and others listed in the FDA recall notice.

Healthcare providers should identify and isolate affected units in their facilities using the product identifiers above and consult the FDA's full recall notice for additional lot numbers and recommended actions.

The recalled product

Product: Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160
Manufacturer: C.R. Bard Inc
Category: Medical Device — Nasogastric Feeding Tube
Hazard: inadequate-suction
inadequate-drainage
Affected units: 51,750

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 00801741113253
Lot/Serial Numbers: NGDX0520
NGES3426
NGET0807
NGET1424
NGEX0089
NGEX1018
NGEY0581
NGEZ0909
NGEZ2672
NGFN1384
NGFN2360
NGFP3401
NGFS4432
NGFT1896
NGFT3418
NGFT5962
NGFV3515
NGFW1858
NGFX0157

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 · inadequate suction