LeMaitre Vascular, Inc. recalls Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
- Recall date
- April 11, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1752-2025
- FDA classification
- Class II
- Brand / firm
- LeMaitre Vascular, Inc.
- Sold / distributed
- Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, DENMARK, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HO…
Why it was recalled
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
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