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LeMaitre Vascular, Inc. recalls LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse
Recalled May 12, 2021 · FDA recall Z-1529-2021 · LeMaitre Vascular
Hazard
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field. · FDA Class II
Units
616 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IL, IN, KY, MA, MO, NY, OH, TN, TX and the countries of Bahamas, Belgium, France, Germany, Hong Kong, Spain.
Description
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
Product
LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.
Manufacturer(s)
LeMaitre Vascular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →