Olympus BiCOAG Hemostasis Probe Recalled for Ceramic Tip Detachment Risk
Olympus is recalling 105 BiCOAG Hemostasis Probes because a manufacturing defect may cause the ceramic tip to detach during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, which corresponds to a High severity score of 3 according to the rubric.
Plain-English summary
Olympus Corporation of the Americas is recalling 105 units of the Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector, Model/Catalog Number CD-B612LA. The recall is due to a manufacturing defect where the designated amount of adhesive was not used, creating a potential for the ceramic tip to detach.
The affected products were distributed worldwide, including the United States, Canada, Latin America, Singapore, Hong Kong, and the European Union. The recall covers all unexpired lots of the product.
Healthcare professionals should stop using the affected probes and contact Olympus for further instructions. Consumers are not expected to have these medical devices in their homes.
The recalled product
- Product
- Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 105
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: CD-B612LA. UDI-DI: 00821925039476. Lot Number: All unexpired lots.
Distribution
Distributed nationwide across the United States.
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