Medical device recalls Moderate risk

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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