FDA recall Z-1529-2021

LeMaitre Vascular, Inc. · Class II · 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.

Reason for recall

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

Distribution

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.

Key facts

Status: Terminated
Initiation date: 2021-04-06
Report date: 2021-05-12
Termination date: 2022-12-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Burlington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1529-2021