Recall archive / FDA device enforcement
Bard¿ Lopez Valve¿ with ENFit, REF EN0056000 — FDA record Z-0801-2024
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¿ Lopez Valve¿ with ENFit, REF EN0056000
- 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
- 187550 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0801-2024
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 00801741113901, Lot/Serial Numbers: NGFU2486, NGFU3807, NGFW1859, NGFX0062, NGFX5625, NGFY0610, NGFZ1664, NGGR0346, NGGR2172, NGGS0703, NGGS2557, NGGS3418, NGGYY001, NGHN0893, NGHQ3357, NGHQ3358, NGHQ3359, NGHQ3383, NGHQ3384, NGHR0028, NGHR0029, NGHR0030, NGHR0031, NGHR0032, NGHR0072, NGHR0073, NGHR0074, NGHR0075, NGHR0159, NGHV0889, NGHV2621, NGHV2722, NGHV3877, NGHW0569, NGHW1488, NGHW3036, NGHW4578, NGHX0643, NGHX0869 |
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.