Merit Medical Systems Inc. initiated a recall of 1,265 units of the Prelude Short Sheath Introducer on Feb. 16 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.
Affected lot numbers: H1041469, H1041473, H1036880, H1041464
Catalog numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT
Manufacturing dates: Nov. 23, 2016 to Nov. 30, 2016
Distribution dates: Dec. 15, 2016 to Jan. 18, 2017