Bard Nasogastric Sump Tubes recalled for reduced suction and drainage
C.R. Bard has recalled certain nasogastric sump tubes due to user reports of inadequate suction and drainage. The affected devices may fail to properly decompress the stomach.
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 Class II medical device with reported functional failures in suction, decompression, and drainage. It qualifies as a risk-of-harm product where injury has not yet been reported, per the Score 3 (High) rubric criterion.
Plain-English summary
C.R. Bard has issued a recall of certain Bard Nasogastric Sump Tubes with PreVent Anti-Reflux Filter and ENFit connectors (14Fr., 48 inches, reference EN0046140) distributed in the United States.
The recall was initiated following user complaints reporting inadequate or reduced suction, decompression, and drainage during use of the device. These tubes are designed to decompress and drain the stomach, and improper function could impact patient care.
The recall affects 36,440 units. The affected lot and serial numbers are: NGDT1999, NGDU4285, NGDX0617, NGES3429, NGET1383, NGEU2115, NGEV4551, NGEX1978, NGEY0623, NGEY2687, NGFN0745, NGFN4316, NGFQ4111, NGFV3444, NGFW1905, NGFX2673, NGFX5526, NGGT4255, NGGU4246, and NGGX5757.
The recalled product
- Product
- Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140
- Manufacturer
- C.R. Bard Inc
- Hazard
- suction-failure
- decompression-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 (20)
- UDI/DI 00801741113246
- Lot/Serial Numbers: NGDT1999
- NGDU4285
- NGDX0617
- NGES3429
- NGET1383
- NGEU2115
- NGEV4551
- NGEX1978
- NGEY0623
- NGEY2687
- NGFN0745
- NGFN4316
- NGFQ4111
- NGFV3444
- NGFW1905
- NGFX2673
- NGFX5526
- NGGT4255
- NGGU4246
Distribution
Distribution scope not specified by the agency.
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