Bard Nasogastric Sump Tube ENFit recalled for inadequate drainage
BD (C.R. Bard) is recalling Bard Nasogastric Sump Tubes with ENFit connectors because users have reported inadequate suction, decompression, and drainage. The devices may not function properly for their intended medical purpose.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 device with documented malfunction (inadequate drainage and reduced suction), but the source reports no injuries. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
BD (C.R. Bard Inc) is recalling 9,860 units of Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter and Lopez Valve® with ENFit (REF EN0056180, 18Fr., 48in long). These devices are used for gastric decompression and drainage in hospitalized patients.
The company has received user complaints reporting inadequate or reduced suction, decompression, and drainage during use of the tubes. This malfunction prevents the devices from providing effective gastric decompression.
Healthcare facilities and patients using these tubes should consult with their healthcare provider regarding appropriate management. Users should contact BD or their medical supplier to discuss replacement options. The affected lot numbers are NGDU4286, NGDX0519, NGES3430, NGET0635, NGEY1509, NGFN0746, NGFQ4112, NGFR2309, NGFT3419, NGFX5614, NGGP3176, NGHS0685, NGHS2419, and NGHT2751.
The recalled product
- Product
- Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN0056180
- Manufacturer
- C.R. Bard Inc
- Affected units
- 9,860
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 (15)
- UDI/DI 00801741113871
- Lot/Serial Numbers: NGDU4286
- NGDX0519
- NGES3430
- NGET0635
- NGEY1509
- NGFN0746
- NGFQ4112
- NGFR2309
- NGFT3419
- NGFX5614
- NGGP3176
- NGHS0685
- NGHS2419
- NGHT2751
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 17 recalled by C.R. Bard Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 17 products in this recall →Related recalls
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Same hazard · inadequate drainage
See all →- HighBard Nasogastric Sump Tubes recalled for inadequate suction and drainage
FDA (Devices) · 2024-01-31
- HighBard PreVent Anti-Reflux Filter with ENFit Recall for Reduced Suction
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- HighBard Nasogastric Sump Tube Recalled for Inadequate Suction and Drainage
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- HighBard Nasogastric Sump Tubes recalled for reduced suction and drainage
FDA (Devices) · 2024-01-31
- HighBard Nasogastric Sump Tube Recalled for Reduced Suction and Drainage
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