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Recall Observatory FDA recall evidence

Device product

Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160

Z-0793-2024

December 20, 2023

Class II

Product summary

Firm
C.R. Bard Inc
Event
Event 93679
Status
Ongoing
Classification
Class II
Quantity
16564 units
Official record key
device-enforcement:Z-0793-2024

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 00801741113802, Lot/Serial Numbers: NGDU4226, NGEQ3059, NGER3655, NGEY1508, NGEY2686, NGEZ2776, NGFP0405, NGFS4370, NGFT5975, NGFU1797, NGFV1674, NGFV3527, NGFW1855, NGFX2682, NGFX5610, NGGV0790

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.