The Recall Desk
HighFDA (Devices)·Z-0805-2024·Announced 2024-01-31

Bard Nasogastric Sump Tube ENFit recalled for inadequate drainage

BD (C.R. Bard) is recalling Bard Nasogastric Sump Tubes with ENFit connectors because users have reported inadequate suction, decompression, and drainage. The devices may not function properly for their intended medical purpose.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device with documented malfunction (inadequate drainage and reduced suction), but the source reports no injuries. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

BD (C.R. Bard Inc) is recalling 9,860 units of Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter and Lopez Valve® with ENFit (REF EN0056180, 18Fr., 48in long). These devices are used for gastric decompression and drainage in hospitalized patients.

The company has received user complaints reporting inadequate or reduced suction, decompression, and drainage during use of the tubes. This malfunction prevents the devices from providing effective gastric decompression.

Healthcare facilities and patients using these tubes should consult with their healthcare provider regarding appropriate management. Users should contact BD or their medical supplier to discuss replacement options. The affected lot numbers are NGDU4286, NGDX0519, NGES3430, NGET0635, NGEY1509, NGFN0746, NGFQ4112, NGFR2309, NGFT3419, NGFX5614, NGGP3176, NGHS0685, NGHS2419, and NGHT2751.

The recalled product

Product
Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN0056180
Manufacturer
C.R. Bard Inc
Hazard
  • inadequate-drainage
  • reduced-suction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • UDI/DI 00801741113871
  • Lot/Serial Numbers: NGDU4286
  • NGDX0519
  • NGES3430
  • NGET0635
  • NGEY1509
  • NGFN0746
  • NGFQ4112
  • NGFR2309
  • NGFT3419
  • NGFX5614
  • NGGP3176
  • NGHS0685
  • NGHS2419
  • NGHT2751

Distribution

Distribution scope not specified by the agency.