Reported May 12, 2021 · Terminated
LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to…
LeMaitre Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LeMaitre Vascular, Inc. · 63 2nd Ave · Burlington, MA · 01803-4413
Is this the product you have?
- LeverEdge Contrast Injector35 cc syringe with ISO 594
- female luer lock - Product Usageintended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00
- Lot codes and dates
- Lot
LCI1091LCI1092LCI1093LCI1094LCI1095LCI1096LCI1097LCI1098LCI1099
- Lot
- Amount recalled
- 616 units
Where it was sold
Why it was recalled
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
This product could cause temporary or reversible health problems — stop using it.
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