LeMaitre Vascular, Inc.: Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.

Hazard

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

Details from the source

Reason for recall: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). Distribution: 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, L Quantity: 26,872 units Lot/code info: UDI-DI: 00840663101580, 00840663101559, 00840663101566, 00840663101597, 00840663101573, 00840663101603. Catalog Numbers: 2102-09, E2102-09. Lot not expired with the following prefix: PIO, QPI, XPI.

UPC codes

00840663101580, 00840663101559, 00840663101566, 00840663101597, 00840663101573, 00840663101603

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.