FDA-Device2021-05-12Class II
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.
LeMaitre Vascular, Inc.
Hazard
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
Sold states
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.
Affected count
616 units
Manufactured in
63 2nd Ave, N/A, Burlington, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1529-2021Don't want to check this manually?
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