FDA-Device2024-04-17Class II
Hemostasis Probe, Model: CD-B622LA
Olympus Corporation of the Americas
Hazard
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.
Sold states
International distribution only.
Affected count
36 units (all OUS)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Hemostasis Probe, Model: CD-B622LA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1481-2024Don't want to check this manually?
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