Bard Nasogastric Sump Tubes recalled due to inadequate suction and drainage
C.R. Bard is recalling 37,059 units of Bard Nasogastric Sump Tubes with ENFit due to user reports of inadequate suction, decompression, 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 medical device recall for functional failure affecting critical care functions (suction and drainage). This is a risk-of-harm product with no reported hospitalizations or injuries mentioned in the source, meeting the High severity criterion.
Plain-English summary
C.R. Bard, Inc. is recalling 37,059 units of Bard Nasogastric Sump Tubes with ENFit (18 French, 48 inches long) due to user complaints of inadequate or reduced suction, decompression, and drainage during use.
The affected product has specific lot numbers: NGDT1997, NGES3427, NGES4095, NGFV0834, NGFV3461, NGFW1886, NGFX5524, NGFY2527, and NGGT3565 (UDI/Device Identifier 00801741113819). These units were distributed in the United States.
Healthcare facilities and individuals should check their inventory against the listed lot numbers. Any units matching these affected lots should be removed from use immediately. Those experiencing inadequate suction, decompression, or drainage should report the issue to the FDA and contact the manufacturer.
The recalled product
- Product
- Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180
- Manufacturer
- C.R. Bard Inc
- Hazard
- suction-failure
- 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 (10)
- UDI/DI 00801741113819
- Lot/Serial Numbers: NGDT1997
- NGES3427
- NGES4095
- NGFV0834
- NGFV3461
- NGFW1886
- NGFX5524
- NGFY2527
- NGGT3565
Distribution
Distribution scope not specified by the agency.
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