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Recall Observatory FDA recall evidence

Device product

Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140

Z-0792-2024

December 20, 2023

Class II

Product summary

Firm
C.R. Bard Inc
Event
Event 93679
Status
Ongoing
Classification
Class II
Quantity
17250 units
Official record key
device-enforcement:Z-0792-2024

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 00801741113796, Lot/Serial Numbers: NGEP0376, NGEQ3035, NGES3428, NGES4109, NGEZ0663, NGFN4314, NGFQ4110, NGFR5254, NGFT0553, NGFT1825, NGFT5022, NGFU1876, NGFV1653, NGFV3456, NGFW1885, NGFX0155, NGFX2654, NGFX5523, NGGQ4983, NGGR2655, NGHR0048

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.