FDA Device recall Z-0801-2024
Bard¿ Lopez Valve¿ with ENFit, REF EN0056000
- FDA Device
- Class II
- ongoing
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of Bard¿ Lopez Valve¿ with ENFit, REF EN0056000 by C R Bard, citing 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 oc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0801-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-20 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | C R Bard |
| Distribution | n/a |
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.
Identifiers
| code_info | UDI/DI 00801741113901, Lot/Serial Numbers: NGFU2486, NGFU3807, NGFW1859, NGFX0062, NGFX5625, NGFY0610, NGFZ1664, NGGR03…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0801-2024%22
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