FDA recall Z-0801-2024

C.R. Bard Inc · Class II · device

Product

Bard¿ Lopez Valve¿ with ENFit, REF EN0056000

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

Key facts

Status: Ongoing
Initiation date: 2023-12-20
Report date: 2024-01-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0801-2024