FDA recall Z-0795-2024

C.R. Bard Inc · Class II · device

Product

Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000

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

US

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-0795-2024