LeMaitre Vascular Recalls LeverEdge Contrast Injectors Due to Packaging Particulates
LeMaitre Vascular is recalling 616 LeverEdge Contrast Injectors because particulates in the packaging foam could contaminate the sterile field.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential contamination of the sterile field by particulates without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 616 units of the LeverEdge Contrast Injector, catalog number 4100-00. This medical device is a 35 cc syringe with an ISO 594 female luer lock intended to perfuse contrast media into vessels for angiographic procedures.
The recall was initiated after the firm received a complaint regarding particulates found in the packaging foam. These particulates could potentially contaminate the sterile field during use. The affected lots are LCI1091 through LCI1099.
The products were distributed worldwide, including nationwide in the United States in the states of AL, CA, FL, IL, IN, KY, MA, MO, NY, OH, TN, and TX, as well as in the Bahamas, Belgium, France, Germany, Hong Kong, and Spain. Users should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- 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.
- Manufacturer
- LeMaitre Vascular, Inc.
- Affected units
- 616
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot: LCI1091
- LCI1092
- LCI1093
- LCI1094
- LCI1095
- LCI1096
- LCI1097
- LCI1098
- LCI1099
Distribution
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