Pruitt Irrigation Occlusion Catheter recall: Sterility Concern
Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
Why was Pruitt Irrigation Occlusion Catheter recalled?
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00840663101580, 00840663101559, 00840663101566, 00840663101597, 00840663101573, 00840663101603. Catalog Numbers: 2102-09, E2102-09. Lot not expired with the following prefix: PIO, QPI, XPI.
- Product
- Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 26,872 units
- 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, 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.
- Recall date
- May 21, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)