The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Merit 7F Prelude Short Sheath Introducers [Lot numbers: H1041469, H1041473, H1036880, H1041464; Catalogue numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT; Manufacturing dates: 23 Nov 2016 to 30 Nov 2016; Distribution dates: 15 Dec 2016 to 18 Jan 2017], manufactured by Merit Medical Systems, Inc.
The manufacturer is recalling the Prelude Short Sheath Introducer due to a manufacturing defect which may cause the tip to separate from the sheath during the insertion procedure.
If this occurs, the tip could enter the patient's bloodstream. This may result in prolonged procedure times, additional surgery to remove the tip from the patient, blood clots, internal tears and perforation to arteries or veins, excessive bleeding, and death.
The manufacturer advises users to quarantine and discontinue use of the affected products and return them to the manufacturer.
For details, please refer to the FDA website:
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm549795.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 March 2017