Bard Nasogastric Sump Tubes recalled for inadequate suction and drainage
C.R. Bard is recalling Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction and drainage during use. The defect may prevent proper gastric decompression.
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 a functional defect in a critical care product. The inadequate suction and drainage capability creates a risk of patient harm through failed gastric decompression, although no illnesses or injuries have been reported to date.
Plain-English summary
C.R. Bard Inc. is recalling Bard Nasogastric Sump Tubes with ENFit connectors, model EN0042120, 12Fr., 48 inches long (UDI/DI 00801741113789). The company has received user complaints reporting inadequate or reduced suction, decompression, and drainage during use of these tubes.
Approximately 6,704 units were distributed in the United States. Affected lot numbers are: NGDU4227, NGDX0616, NGEQ3058, NGER3569, NGFN0711, NGFS4430, NGFT1895, NGFT5466, NGFU2448, NGFV1675, NGFW1843, NGFX0166, NGFY2526, NGGR2645, NGGT2116, and NGHQ2394.
Healthcare facilities should verify their inventory against these lot numbers and discontinue use of affected units. Providers and patients with questions should contact C.R. Bard or their healthcare provider.
The recalled product
- Product
- Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120
- 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 (17)
- UDI/DI 00801741113789
- Lot/Serial Numbers: NGDU4227
- NGDX0616
- NGEQ3058
- NGER3569
- NGFN0711
- NGFS4430
- NGFT1895
- NGFT5466
- NGFU2448
- NGFV1675
- NGFW1843
- NGFX0166
- NGFY2526
- NGGR2645
- NGGT2116
- NGHQ2394
Distribution
Distribution scope not specified by the agency.
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