The Recall Desk
HighFDA (Devices)·Z-0800-2024·Announced 2024-01-31

Bard Nasogastric Sump Tube Recalled for Reduced Suction and Drainage

C.R. Bard is recalling Bard Nasogastric Sump Tubes due to reports of inadequate or reduced suction, decompression, and drainage during use. The recall affects 57,159 units distributed in the United States.

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 with reported functional failure (reduced suction and decompression) but no reported hospitalizations or injuries. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, meeting the High severity threshold.

Plain-English summary

C.R. Bard Inc. is recalling Bard Nasogastric Sump Tubes with PreVent Anti-Reflux Filter and ENFit Connectors (18 French, 48 inches long, REF EN0046180). The recall affects 57,159 units distributed in the United States. Affected units can be identified by the UDI/DI 00801741113260 or by checking the lot number.

The recall was initiated following user reports that the tubes experienced inadequate or reduced suction, decompression, and drainage during use. These devices are designed to provide gastric decompression and drainage, and reduced functionality could affect their clinical performance.

Healthcare providers and facilities using these tubes should verify whether they have affected units by checking lot numbers and the UDI. Affected units should be discontinued from use, and facilities should contact C.R. Bard for information about replacements and further guidance.

The recalled product

Product
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180
Manufacturer
C.R. Bard Inc
Hazard
  • device-malfunction
  • 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 (20)

  • UDI/DI 00801741113260
  • Lot/Serial Numbers: NGDT2000
  • NGDX0518
  • NGEW1822
  • NGEW3855
  • NGEX0043
  • NGEX1998
  • NGEZ2693
  • NGFP0406
  • NGFP3519
  • NGFR0244
  • NGFT0418
  • NGFT3481
  • NGFU3821
  • NGFV0785
  • NGFV1654
  • NGFV3445
  • NGFW1906
  • NGFX0169
  • NGFX2674

Distribution

Distribution scope not specified by the agency.