Open, Classified

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

FDA Recall Z-1752-2025 · Posted 2025-05-12

Recalling FirmLeMaitre Vascular, Inc.

Recall StatusOpen, Classified

Product CodeDQT

Date Initiated2025-04-11

Product Quantity26,872 units

Reason for Recall

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

Firm Action

LeMaitre notified OUS consignees beginning on 04/11/2025, and US consignees on 04/23/2025 via email and letter. Consignees were instructed to not use the devices, immediately quarantine any on hand, and complete and return the response form. Once received a LeMaitre Vascular representative will contact customers to provide return instructions. If the products were transferred or further distributed, customers were instructed to notify those customers and provide a copy of the recall letter.

Root Cause

Packaging process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K880231MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETERIdeas For Medicine, Inc. · 1988-05-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.