Agency classClass IIOur severity:High FDA (Devices)·Z-0806-2024·Announced 2024-01-31

Bard Suction Connector with ENFit Recalled for Inadequate Drainage

C.R. Bard is recalling 133,610 Bard Suction Connectors with ENFit (model EN0066000) due to user complaints of inadequate suction and drainage. No injuries have been reported.

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: This is a risk-of-harm medical device where the core function (suction and drainage) fails, creating potential complications in nasogastric tube management. However, the source reports no actual illnesses or injuries, and the FDA classification is Class II, placing it at High per the rubric criteria.

Plain-English summary

C.R. Bard Inc. is recalling 133,610 units of the Bard® Suction Connector with ENFit (model EN0066000, UDI/DI 00801741128707). The recall was initiated following user complaints reporting that the connector experienced inadequate or reduced suction, decompression, and drainage during normal use.

The affected product was distributed throughout the United States. Affected lot and serial numbers include NGFS2792, NGFS4371, NGFV1647, NGFV1669, and 26 others, available from the manufacturer.

If you have this product in use or in inventory, contact C.R. Bard Inc. immediately for instructions on return, replacement, or disposal. Healthcare facilities and users should cease use of affected units.

The recalled product

Product: Bard¿ Suction Connector with ENFit, REF EN0066000
Manufacturer: C.R. Bard Inc
Category: Medical Device — Nasogastric Tube Connector
Hazard: inadequate-suction
drainage-failure
Affected units: 133,610

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 00801741128707
Lot/Serial Numbers: NGFS2792
NGFS4371
NGFV1647
NGFV1669
NGGN1988
NGGN2930
NGGN3517
NGGP0451
NGGP1098
NGGV0739
NGGV2722
NGGV5069
NGGW4456
NGGX3169
NGGZ0564
NGGZ1915
NGHP2225
NGHQ2201
NGHR0090

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 · inadequate suction