The Recall Desk
HighFDA (Devices)·Z-0799-2024·Announced 2024-01-31

Bard Nasogastric Sump Tube Recalled for Reduced Suction and Drainage

C.R. Bard is recalling 51,750 Bard Nasogastric Sump Tubes with PreVent Anti-Reflux Filter due to reports of inadequate suction and drainage during use.

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 classification without reported hospitalizations or injuries. The product failure (inadequate suction and drainage) poses a potential risk of harm to patients requiring nasogastric tube use, fitting the criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

C.R. Bard Inc. is recalling 51,750 units of Bard® Nasogastric Sump Tubes with PreVent® Anti-Reflux Filter with ENFit, 16Fr., 48 inches long (REF EN0046160). The FDA classified this as a Class II recall. User complaints reported that during use, these tubes exhibited inadequate or reduced suction, decompression, and drainage.

The affected product was distributed in the United States. Affected units can be identified using UDI/DI 00801741113253 and specific lot numbers including NGDX0520, NGES3426, NGET0807, NGET1424, and others listed in the FDA recall notice.

Healthcare providers should identify and isolate affected units in their facilities using the product identifiers above and consult the FDA's full recall notice for additional lot numbers and recommended actions.

The recalled product

Product
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160
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 00801741113253
  • Lot/Serial Numbers: NGDX0520
  • NGES3426
  • NGET0807
  • NGET1424
  • NGEX0089
  • NGEX1018
  • NGEY0581
  • NGEZ0909
  • NGEZ2672
  • NGFN1384
  • NGFN2360
  • NGFP3401
  • NGFS4432
  • NGFT1896
  • NGFT3418
  • NGFT5962
  • NGFV3515
  • NGFW1858
  • NGFX0157

Distribution

Distribution scope not specified by the agency.