CanadaBiCOAG Hemostasis Probe devices by Gyrus Acmi, Inc with model numbers CD-B622LA, CD-B612LA (Fixed Pin Connector) and CD-B610LA, CD-B620LA (Coaxial Connector) and lot/serial numbers of more than 10 digits are affected. Olympus determined some units may have been manufactured without the designated amount of adhesive to the rear of the ceramic tip, which may result in tip detachment; customers should immediately discontinue use and contact Olympus to return the product or contact the manufacturer for more information.
What's being recalled
Companies: Gyrus Acmi, Inc, 9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445.
How to identify it
Affected products: BiCOAG Hemostasis Probe - Fixed Pin Connector; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: CD-B622LA
Affected products: BiCOAG Hemostasis Probe - Fixed Pin Connector; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: CD-B612LA
Affected products: BiCOAG Hemostasis Probe - Coaxial Connector; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: CD-B610LA
Affected products: BiCOAG Hemostasis Probe - Coaxial Connector; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: CD-B620LA
The hazard
Olympus determined that the affected products may have been manufactured without the designated amount of adhesive to the rear of the device’s ceramic tip, which may result in detachment of the ceramic tip. Customers should immediately discontinue using the BiCOAG Hemostasis Probe products and contact Olympus to return the product.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)