DISPOSABLE REFLECTIVE MARKER SPHERES

Description of Event or Problem

THIS EVENT WAS COMMUNICATED BY (B)(6) FROM (B)(6) HOSPITAL IN RESPONSE TO A RECALL NOTICE ISSUED FOR THE SAME MODEL OF SPHERES. AS NOTED BY THE COMPLAINANT: "UPON DISTRIBUTION OF THIS RECALL NOTICE INTERNALLY IT WAS DISCOVERED THAT AN INCIDENT AS DESCRIBED IN THE NOTICE HAD OCCURRED AT OUR FACILITY ON THE SAME PRODUCT WITH A DIFFERENT LOT NUMBER." CUSTOMER RETURNED SPHERE AS TWO SEPARATE HEMISPHERES. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER AS TO THE NATURE OF THE INCIDENT.