Medical device manufacturer, Boston Scientific, has issued a medical device safety alert to St. Francis Hospital in the US concerning its ASSY STERILE CUTTER GLOBAL "Model 7060 ACUITY Cutter" [UPN: 667060-303; Lot Number: H1937249; GTIN: 08714729936176].
According to the manufacturer, five units of the affected products distributed to that hospital did not undergo the applicable sterile processing procedure. Compromised product sterility may lead to contamination of the sterile surgical field during an implant procedure.
The manufacturer advises users to immediately segregate all affected product to ensure that it will not be used. If affected product has been used, affected users should inform the implanting physician for appropriate patient management.
According to the local supplier, the affected product is not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 18 December 2020