Z-1481-2024 Class II Ongoing
FDA device recall Z-1481-2024 was initiated by Olympus Corporation Of The Americas on Jan 5, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 36 units (all OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Apr 17, 2024
- Initiation Date
- Jan 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 units (all OUS)
Product Description
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 Pattern
International distribution only.
Code Information
Model Number: CD-B622LA; UDI/DI: 00821925039452; Lot Number: KR214212
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1481-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026