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.
FDA Recall Z-1529-2021 · Posted None
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Recalling FirmLeMaitre Vascular, Inc.
Recall StatusTerminated
Product CodeDXT
Date Initiated2021-04-06
Date Terminated2022-12-29
Product Quantity616 units
Reason for Recall
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
Firm Action
On 04/01/2021, LeMaitre issued an Urgent Medical Device Removal notice via letter informing customers that particulate contamination has been detected from the packaging foam with these devices.
Root Cause
Process control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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