FDA recall Z-0802-2024

C.R. Bard Inc · Class II · device

Product

Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 12Fr., 48in Long, REF EN0056120

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-0802-2024