Recall Z-1529-2021— LeMaitre Vascular, Inc.

Name: FDA recall Z-1529-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-06

Class II · Terminated

Class II FDA medical device recall by LeMaitre Vascular, Inc., initiated 2021-04-06, terminated 2022-12-29. It names one FDA 510(k) clearance: K973334. 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: The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field..

Recalling firm: LeMaitre Vascular, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-04-06
Terminated: 2022-12-29
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K973334 — OZ POWER SYRINGECardiovascular Innovations·cleared 1998-04-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.