The Recall Desk
HighFDA (Devices)·Z-0792-2024·Announced 2024-01-31

Bard Nasogastric Sump Tubes recalled for reduced suction and drainage

C.R. Bard is recalling 17,250 Bard Nasogastric Sump Tubes with ENFit connectors due to user complaints of inadequate or reduced suction, decompression, and drainage during use. These tubes 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 recall without reported hospitalizations or injuries. This is a risk-of-harm product where functional failure could affect patient care, but no injuries have been reported to date, warranting a High severity designation per the recall rubric.

Plain-English summary

C.R. Bard Inc. is recalling 17,250 units of the Bard Nasogastric Sump Tube with ENFit (Reference EN0042140, 14 French gauge, 48 inches long), distributed in the United States. The recall was issued after C.R. Bard received user complaints reporting that during use, these tubes experienced inadequate or reduced suction, decompression, and drainage.

Nasogastric sump tubes are medical devices used for gastric decompression and drainage in clinical and hospital settings. Failure to provide adequate suction and drainage could compromise the intended function of the device.

The recalled product can be identified by UDI/DI code 00801741113796 and the following lot numbers: NGEP0376, NGEQ3035, NGES3428, NGES4109, NGEZ0663, NGFN4314, NGFQ4110, NGFR5254, NGFT0553, NGFT1825, NGFT5022, NGFU1876, NGFV1653, NGFV3456, NGFW1885, NGFX0155, NGFX2654, NGFX5523, NGGQ4983, NGGR2655, NGHR0048.

The recalled product

Product
Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140
Manufacturer
C.R. Bard Inc
Hazard
  • inadequate-suction
  • inadequate-drainage

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 (20)

  • 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

Distribution

Distribution scope not specified by the agency.