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LeMaitre Vascular, Inc. recalls Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
Recalled May 21, 2025 · FDA recall Z-1752-2025 · LeMaitre Vascular
Hazard
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). · FDA Class II
Units
26,872 units
Sold at
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, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORTH MACEDONIA, NORWAY, OMAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKIYE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.
Description
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Product
Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
Manufacturer(s)
LeMaitre Vascular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →