FDAFDA · Food and drugs·Recall number Z-1481-2024
Hemostasis Probe, Model: CD-B622LA
Published April 17, 2024 · Recall initiated: January 5, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- International distribution only.
- Lot
- Model Number: CD-B622LA; UDI/DI: 00821925039452; Lot Number: KR214212
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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