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.
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 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
- Hazard
- reduced-suction
- drainage-failure
- decompression-failure
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.
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