The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0801-2024·Announced 2024-01-31

Nasogastric Valve Recalled for Reduced Suction and Drainage

C.R. Bard Inc. is recalling approximately 187,550 Bard Lopez Valve units due to user complaints of inadequate suction, decompression, and drainage during use. No illnesses or injuries have been reported.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 FDA Class II recall involves a medical device whose malfunction could impair critical gastric functions. However, no illnesses or injuries have been reported, classifying this as a risk-of-harm scenario without documented patient harm.

Plain-English summary

C.R. Bard Inc. (now part of BD) is recalling the Bard Lopez Valve with ENFit (model EN0056000), a component of nasogastric sump tubes. Approximately 187,550 units have been distributed in the United States.

The company received user complaints indicating that during use, the valve may experience inadequate or reduced suction, decompression, and drainage. No illnesses or injuries have been reported in connection with these complaints.

Patients and healthcare facilities using affected units should contact their healthcare provider or C.R. Bard Inc. for guidance. The FDA classified this as a Class II recall.

The recalled product

Product
Bard¿ Lopez Valve¿ with ENFit, REF EN0056000
Manufacturer
C.R. Bard Inc
Category
Medical Device — Nasogastric Tube
Hazard
Affected units
187,550

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 00801741113901
  • Lot/Serial Numbers: NGFU2486
  • NGFU3807
  • NGFW1859
  • NGFX0062
  • NGFX5625
  • NGFY0610
  • NGFZ1664
  • NGGR0346
  • NGGR2172
  • NGGS0703
  • NGGS2557
  • NGGS3418
  • NGGYY001
  • NGHN0893
  • NGHQ3357
  • NGHQ3358
  • NGHQ3359
  • NGHQ3383
  • NGHQ3384

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 17 recalled by C.R. Bard Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

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