Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1529-2021

April 06, 2021

Class II

Product summary

Firm
LeMaitre Vascular, Inc.
Event
Event 87689
Status
Terminated
Classification
Class II
Quantity
616 units
Official record key
device-enforcement:Z-1529-2021

Official wording

Reason: The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.

Code information: Lot: LCI1091, LCI1092, LCI1093, LCI1094, LCI1095, LCI1096, LCI1097, LCI1098, LCI1099

Distribution pattern: 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.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate