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Recall Observatory FDA recall evidence

Device product

Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180

Z-0794-2024

December 20, 2023

Class II

Product summary

Firm
C.R. Bard Inc
Event
Event 93679
Status
Ongoing
Classification
Class II
Quantity
37059 units
Official record key
device-enforcement:Z-0794-2024

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 00801741113819, Lot/Serial Numbers: NGDT1997, NGES3427, NGES4095, NGFV0834, NGFV3461, NGFW1886, NGFX5524, NGFY2527, NGGT3565

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.