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.
Reported: May 12, 2021 Initiated: April 6, 2021 #Z-1529-2021
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.
Details
- Recalling Firm
- LeMaitre Vascular, Inc.
- Units Affected
- 616 units
- 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.
- Location
- Burlington, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by LeMaitre Vascular, Inc.. Units affected: 616 units.
Why was this product recalled? ▼
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 12, 2021. Severity: Moderate. Recall number: Z-1529-2021.
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