Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120
Summary
The FDA issued a Class II for Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., by C.R. Bard Inc. Reason: 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, d.
Details
Source
Device Recall
External ID
Z-0797-2024
Action Date
2024-01-31
Status
Ongoing
Category
device
Product Description
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120
Lot/Code Info: UDI/DI 00801741113239, Lot/Serial Numbers: NGDT1998, NGDZ3287, NGEU0889, NGEU2134, NGEV2411, NGEW2655, NGEY1506, NGEZ0664, NGFN4265, NGFU4024, NGFV3514, NGFW1857, NGFX0168, NGFX2645, NGGQ8458, NGGR2705, NGGX4777
Quantity Affected: 26100 units
Reason for Recall
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.
Distribution
US
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-20
Company
Covington, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 144 device recalls issued in the same week, part of 413 device-related FDA actions this month.
C.R. Bard Inc has 78 FDA actions in our database, including 64 recalls and 14 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (C.R. Bard Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does C.R. Bard Inc have FDA actions?
C.R. Bard Inc has 78 FDA actions in our database, including 64 recalls and 14 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0797-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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