Device product
Hemostasis Probe, Model: CD-B622LA
Z-1481-2024
Product summary
- Event
- Event 94150
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 36 units (all OUS)
- Official record key
device-enforcement:Z-1481-2024
Official wording
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 information: Model Number: CD-B622LA; UDI/DI: 00821925039452; Lot Number: KR214212
Distribution pattern: International distribution only.
Derived failure modes
-
Labeling or packaging
mispackaged