Device recall: Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100
Class II FDA enforcement event 93679. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Class II, in the words of FDA
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
C.R. Bard Inc started this device recall on 20 Dec 2023. The firm address in the FDA record is in Covington, GA. FDA put the recall in Class II. FDA event 93679 has 17 product records. The first FDA enforcement report date is 31 Jan 2024. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US
Recalling firm
C.R. Bard Inc, Covington, GA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
17 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0790-2024 | Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100 | 3400 units | Class II | Ongoing | 31 Jan 2024 |
| Z-0791-2024 | Bard Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120 | 6704 units | Class II | Ongoing | 31 Jan 2024 |
| Z-0792-2024 | Bard Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140 | 17250 units | Class II | Ongoing | 31 Jan 2024 |
| Z-0793-2024 | Bard Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160 | 16564 units | Class II | Ongoing | 31 Jan 2024 |
| Z-0794-2024 | Bard Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180 | 37059 units | Class II | Ongoing | 31 Jan 2024 |
| Z-0795-2024 | Bard PreVent Anti-Reflux Filter with ENFit, REF EN0046000 | 39430 units | Class II | Ongoing | 31 Jan 2024 |
| Z-0796-2024 | Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100 | 6600 units | Class II | Ongoing | 31 Jan 2024 |
| Z-0797-2024 | Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120 | 26100 units | Class II | Ongoing | 31 Jan 2024 |
| Z-0798-2024 | Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140 | 36440 units | Class II | Ongoing | 31 Jan 2024 |
| Z-0799-2024 | Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160 | 51750 units | Class II | Ongoing | 31 Jan 2024 |
| Z-0800-2024 | Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180 | 57159 units | Class II | Ongoing | 31 Jan 2024 |
| Z-0801-2024 | Bard Lopez Valve with ENFit, REF EN0056000 | 187550 units | Class II | Ongoing | 31 Jan 2024 |
| Z-0802-2024 | Bard Nasogastric Sump Tube and PreVent Anti-Reflux Filter and Lopez Valve with ENFit, 12Fr., 48in Long, REF EN0056120 | 3360 units | Class II | Ongoing | 31 Jan 2024 |
| Z-0803-2024 | Bard Nasogastric Sump Tube and PreVent Filter and Lopez Valve with ENFit, 14Fr., 48in Long, REF EN0056140 | 3650 units | Class II | Ongoing | 31 Jan 2024 |
| Z-0804-2024 | Bard Nasogastric Sump Tube and PreVent Filter and Lopez Valve with ENFit, 16Fr., 48in Long, REF EN0056160 | 8010 units | Class II | Ongoing | 31 Jan 2024 |
| Z-0805-2024 | Bard Nasogastric Sump Tube and PreVent Anti-Reflux Filter and Lopez Valve with ENFit, 18Fr., 48in Long, REF EN0056180 | 9860 units | Class II | Ongoing | 31 Jan 2024 |
| Z-0806-2024 | Bard Suction Connector with ENFit, REF EN0066000 | 133610 units | Class II | Ongoing | 31 Jan 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 17Median of the firm: 1
- Events of the firm on the register
- 49
Other events of the firm
Official channels
- FDA enforcement report Z-0790-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 93679. https://recallregister.com/fda/ii/93679/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US
- What quantity of product is in FDA event 93679?
- The event has 17 product records. The first record gives this quantity:
3400 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.