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Recall Observatory FDA recall evidence

Device product

Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120

Z-0791-2024

December 20, 2023

Class II

Product summary

Firm
C.R. Bard Inc
Event
Event 93679
Status
Ongoing
Classification
Class II
Quantity
6704 units
Official record key
device-enforcement:Z-0791-2024

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 00801741113789, Lot/Serial Numbers: NGDU4227, NGDX0616, NGEQ3058, NGER3569, NGFN0711, NGFS4430, NGFT1895, NGFT5466, NGFU2448, NGFV1675, NGFW1843, NGFX0166, NGFY2526, NGGR2645, NGGT2116, NGHQ2394

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.