Bard Nasogastric Sump Tube with ENFit Recalled for Reduced Suction and Drainage
C.R. Bard is recalling 3,400 units of Bard Nasogastric Sump Tube with ENFit due to reports of inadequate suction, decompression, and drainage during use affecting patients requiring nasogastric care.
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 a FDA Class II recall of a medical device with reported functional defects but no illnesses or injuries reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a score of 3 (High).
Plain-English summary
C.R. Bard Inc is recalling 3,400 units of the Bard Nasogastric Sump Tube with ENFit, 10 French, 36 inches long (REF EN0042100) distributed in the United States. The affected units are identified by lot numbers NGEQ3034, NGER3656, NGFX0154, NGGR1392, NGGT2088, and NGHQ2161.
The company received user complaints reporting that the tubes are experiencing inadequate or reduced suction, decompression, and drainage during clinical use. These functional failures could compromise the device's ability to properly decompress and drain the stomach in patients requiring nasogastric tube support.
This recall affects patients using these tubes in hospitals, clinics, and other healthcare settings where nasogastric decompression and drainage is medically necessary.
Healthcare providers and patients currently using affected tubes should discontinue use immediately. Contact C.R. Bard Inc for instructions on obtaining replacement tubes or for questions about affected lot numbers.
The recalled product
- Product
- Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100
- Manufacturer
- C.R. Bard Inc
- Hazard
- device-malfunction
- reduced-suction
- drainage-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 (7)
- UDI/DI 00801741113772
- Lot/Serial Numbers: NGEQ3034
- NGER3656
- NGFX0154
- NGGR1392
- NGGT2088
- NGHQ2161
Distribution
Distribution scope not specified by the agency.
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