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.
What this means for you
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
- Hazard
- inadequate-suction
- drainage-failure
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.
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