Recall archive / FDA device enforcement
Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000 — FDA record Z-0795-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 20, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000
- 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, decompression, and drainage occurred.
- Classification
- Class II
- Recalling firm
- C.R. Bard Inc
- Quantity
- 39430 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0795-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 00801741113765, Lot/Serial Numbers: NGEV2409, NGEY1492, NGEY2717, NGEZ0908, NGEZ1657, NGEZ2692, NGFQ4105, NGFR1077, NGFR2312, NGFR3259, NGFS1627, NGFS4431, NGFT5468, NGFU1877, NGFU3837, NGFV1652, NGFV3513, NGFW1856, NGFX0167, NGFX2672, NGFX5611, NGGP3169, NGGT3611 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jan 31, 2024
- Recall initiation date
- Dec 20, 2023
- Center classification date
- Jan 25, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.