The Recall Desk
HighFDA (Devices)·Z-0803-2024·Announced 2024-01-31

Bard Nasogastric Sump Tube Recalled Due to Reduced Suction and Drainage

C.R. Bard is recalling 3,650 units of Bard Nasogastric Sump Tubes with ENFit connectors due to user complaints of inadequate suction, decompression, and drainage during use. The issue could affect proper tube function in clinical settings.

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 medical device recall without reported hospitalizations or injuries. The reduced suction and decompression function represents a risk-of-harm scenario where injury has not yet been reported, meeting the High severity criterion.

Plain-English summary

C.R. Bard, Inc. is recalling 3,650 units of the Bard Nasogastric Sump Tube with PreVent Filter and Lopez Valve with ENFit connector (14 French, 48 inches long, model EN0056140). Affected lot numbers are NGEX0090, NGEX1982, NGEZ2116, NGGP3242, NGHQ1395, and NGHQ1411.

The recall was initiated following user complaints that during use, these tubes exhibited inadequate or reduced suction, decompression, and drainage. These functions are essential for proper tube operation in clinical settings.

The recalled tubes were distributed in the United States.

The recalled product

Product
Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140
Manufacturer
C.R. Bard Inc
Hazard
  • device-malfunction
  • suction-failure

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 (7)

  • UDI/DI 00801741113857
  • Lot/Serial Numbers: NGEX0090
  • NGEX1982
  • NGEZ2116
  • NGGP3242
  • NGHQ1395
  • NGHQ1411

Distribution

Distribution scope not specified by the agency.