The Recall Desk
HighFDA (Devices)·Z-0796-2024·Announced 2024-01-31

Bard Nasogastric Sump Tubes recalled for inadequate suction and drainage

C.R. Bard is recalling Bard Nasogastric Sump Tubes due to user complaints of inadequate suction and drainage during use. Approximately 6,600 units were affected.

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 medical device recall for functional failure in a nasogastric sump tube. Although no injuries or illnesses have been reported in the source text, the device failure presents a risk of harm due to inadequate decompression and drainage capability, meeting the criterion for High severity.

Plain-English summary

C.R. Bard Inc is recalling the Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit (REF EN0046100). The recall affects approximately 6,600 units distributed in the United States, with affected lot numbers: NGDX0768, NGDZ3314, NGER3568, NGFT5023, NGFV3443, NGFW1904, NGFX0156, NGFX5525, NGGQ8459, and NGGW4504.

Users have reported that during use of these nasogastric sump tubes, inadequate or reduced suction, decompression, and drainage occurred. The device is intended for gastric decompression and drainage, and failure to function properly may result in clinical complications.

Healthcare providers and patients currently using the affected tubes should stop use and contact C.R. Bard Inc for information regarding replacement or return of the product.

The recalled product

Product
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100
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 (11)

  • UDI/DI 00801741113222
  • Lot/Serial Numbers: NGDX0768
  • NGDZ3314
  • NGER3568
  • NGFT5023
  • NGFV3443
  • NGFW1904
  • NGFX0156
  • NGFX5525
  • NGGQ8459
  • NGGW4504

Distribution

Distribution scope not specified by the agency.