FDA Enforcement
Class II
Ongoing
Hemostasis Probe, Model: CD-B622LA
Recall: Z-1481-2024
·
Reported April 17, 2024
Enforcement
- Recall Number
- Z-1481-2024
- Event ID
- 94150
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 17, 2024
- Initiation Date
- January 5, 2024
- Classification Date
- April 5, 2024
- Address
- 3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States
Description
Hemostasis Probe, Model: CD-B622LA
Reason
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.
Code Info
Model Number: CD-B622LA; UDI/DI: 00821925039452; Lot Number: KR214212
Distribution
International distribution only.
Quantity
36 units (all OUS)