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Recall Observatory FDA recall evidence

Device product

Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140

Z-0798-2024

December 20, 2023

Class II

Product summary

Firm
C.R. Bard Inc
Event
Event 93679
Status
Ongoing
Classification
Class II
Quantity
36440 units
Official record key
device-enforcement:Z-0798-2024

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 00801741113246, Lot/Serial Numbers: NGDT1999, NGDU4285, NGDX0617, NGES3429, NGET1383, NGEU2115, NGEV4551, NGEX1978, NGEY0623, NGEY2687, NGFN0745, NGFN4316, NGFQ4111, NGFV3444, NGFW1905, NGFX2673, NGFX5526, NGGT4255, NGGU4246, NGGX5757

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.