Bard Nasogastric Sump Tube Recalled for Inadequate Suction and Drainage
C.R. Bard Inc is recalling 8,010 units of Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction, decompression, and drainage.
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: This is an FDA Class II device recall with reported functional failure (inadequate suction and decompression). No injuries or illnesses are reported in the source. Per the rubric, a risk-of-harm medical device without reported injuries scores as High (3).
Plain-English summary
C.R. Bard Inc is recalling Bard Nasogastric Sump Tubes with ENFit connectors (16Fr., 48 inches long, REF EN0056160). The recall affects 8,010 units distributed in the United States.
The company received user complaints reporting that during use of these tubes, inadequate or reduced suction, decompression, and drainage occurred.
Affected units have the following lot/serial numbers: NGDU4284, NGEP0365, NGER3654, NGGR2706, NGGT2087, and NGHW4543. The UDI/DI is 00801741113864.
Users of affected units should contact C.R. Bard Inc for information or replacements.
The recalled product
- Product
- Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long , REF EN0056160
- Manufacturer
- C.R. Bard Inc
- Category
- Medical Device — Medical Tubing
- Affected units
- 8,010
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 00801741113864
- Lot/Serial Numbers: NGDU4284
- NGEP0365
- NGER3654
- NGGR2706
- NGGT2087
- NGHW4543
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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