Olympus Corporation of the Americas — Class II: Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.
Olympus Corporation of the Americas has initiated a Class II recall for the BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector (Model CD-B622LA). The recall was issued due to a manufacturing error where the ceramic tip may detach because the designated amount of adhesive was not applied.
This recall affects Olympus Corporation of the Americas, healthcare facilities utilizing these specific hemostasis probes, and quality/manufacturing departments responsible for adhesive bonding processes.
A detached ceramic tip during a procedure presents a potential clinical risk, including possible foreign body retention or procedural delay. From a regulatory perspective, this suggests a failure in manufacturing process controls or assembly validation, necessitating a review of CAPA procedures to ensure adhesive application consistency.
Quality teams should review adhesive application procedures and validation records for multi-component instruments. Manufacturing should verify that current assembly workflows include sufficient controls to ensure the designated amount of bonding agent is consistently applied.
Class II. Reason: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.. Product: Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.. Firm: Olympus Corporation of the Americas (Center Valley PA United States). Status: Ongoing.
Open in openFDA / FDA.gov