FDA recall Z-1481-2024

Olympus Corporation of the Americas · Class II · device

Product

Hemostasis Probe, Model: CD-B622LA

Reason for recall

The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.

Distribution

International distribution only.

Key facts

Status
Ongoing
Initiation date
2024-01-05
Report date
2024-04-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1481-2024