The Recall Desk
HighFDA (Devices)·Z-0804-2024·Announced 2024-01-31

Bard Nasogastric Sump Tube Recalled for Inadequate Suction and Drainage

C.R. Bard Inc is recalling 8,010 units of Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction, decompression, and drainage.

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: This is an FDA Class II device recall with reported functional failure (inadequate suction and decompression). No injuries or illnesses are reported in the source. Per the rubric, a risk-of-harm medical device without reported injuries scores as High (3).

Plain-English summary

C.R. Bard Inc is recalling Bard Nasogastric Sump Tubes with ENFit connectors (16Fr., 48 inches long, REF EN0056160). The recall affects 8,010 units distributed in the United States.

The company received user complaints reporting that during use of these tubes, inadequate or reduced suction, decompression, and drainage occurred.

Affected units have the following lot/serial numbers: NGDU4284, NGEP0365, NGER3654, NGGR2706, NGGT2087, and NGHW4543. The UDI/DI is 00801741113864.

Users of affected units should contact C.R. Bard Inc for information or replacements.

The recalled product

Product
Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long , REF EN0056160
Manufacturer
C.R. Bard Inc
Hazard
  • inadequate-drainage
  • inadequate-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 (7)

  • UDI/DI 00801741113864
  • Lot/Serial Numbers: NGDU4284
  • NGEP0365
  • NGER3654
  • NGGR2706
  • NGGT2087
  • NGHW4543

Distribution

Distribution scope not specified by the agency.