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Recall Observatory FDA recall evidence

Device product

Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120

Z-0797-2024

December 20, 2023

Class II

Product summary

Firm
C.R. Bard Inc
Event
Event 93679
Status
Ongoing
Classification
Class II
Quantity
26100 units
Official record key
device-enforcement:Z-0797-2024

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 00801741113239, Lot/Serial Numbers: NGDT1998, NGDZ3287, NGEU0889, NGEU2134, NGEV2411, NGEW2655, NGEY1506, NGEZ0664, NGFN4265, NGFU4024, NGFV3514, NGFW1857, NGFX0168, NGFX2645, NGGQ8458, NGGR2705, NGGX4777

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.