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Recall Observatory FDA recall evidence

Device product

Bard¿ Suction Connector with ENFit, REF EN0066000

Z-0806-2024

December 20, 2023

Class II

Product summary

Firm
C.R. Bard Inc
Event
Event 93679
Status
Ongoing
Classification
Class II
Quantity
133610 units
Official record key
device-enforcement:Z-0806-2024

Official wording

Reason: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

Code information: 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, NGHS1005, NGHS1006, NGHS2421, NGHS3331, NGHU0845, NGHU1555, NGHV0467, NGHV2758, NGHW3025, NGHX1021, NGHX3269

Distribution pattern: US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.