Agency classClass IIOur severity:High FDA (Devices)·Z-0791-2024·Announced 2024-01-31

Bard Nasogastric Sump Tubes recalled for inadequate suction and drainage

C.R. Bard is recalling Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction and drainage during use. The defect may prevent proper gastric 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 for a functional defect in a critical care product. The inadequate suction and drainage capability creates a risk of patient harm through failed gastric decompression, although no illnesses or injuries have been reported to date.

Plain-English summary

C.R. Bard Inc. is recalling Bard Nasogastric Sump Tubes with ENFit connectors, model EN0042120, 12Fr., 48 inches long (UDI/DI 00801741113789). The company has received user complaints reporting inadequate or reduced suction, decompression, and drainage during use of these tubes.

Approximately 6,704 units were distributed in the United States. Affected lot numbers are: NGDU4227, NGDX0616, NGEQ3058, NGER3569, NGFN0711, NGFS4430, NGFT1895, NGFT5466, NGFU2448, NGFV1675, NGFW1843, NGFX0166, NGFY2526, NGGR2645, NGGT2116, and NGHQ2394.

Healthcare facilities should verify their inventory against these lot numbers and discontinue use of affected units. Providers and patients with questions should contact C.R. Bard or their healthcare provider.

The recalled product

Product: Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120
Manufacturer: C.R. Bard Inc
Category: Medical Device — Nasogastric Tube
Hazard: suction-failure
drainage-failure
Affected units: 6,704

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 (17)

UDI/DI 00801741113789
Lot/Serial Numbers: NGDU4227
NGDX0616
NGEQ3058
NGER3569
NGFN0711
NGFS4430
NGFT1895
NGFT5466
NGFU2448
NGFV1675
NGFW1843
NGFX0166
NGFY2526
NGGR2645
NGGT2116
NGHQ2394

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 · suction failure