Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
FDA device recall Z-1751-2025 · posted 2025-05-12 · Open, Classified
Recall details
- Recalling firm
- LeMaitre Vascular, Inc.
- Reason for recall
- During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
- Action taken
- 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
- Status
- Open, Classified
- Product code
- DYG
- Quantity affected
- 65,977 units
- Distribution
- Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, DENMARK, DOMINICAN REPU
- Date initiated
- 2025-04-11
- Date posted
- 2025-05-12
- Location
- Burlington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OCCLUSION CATHETER (K811276) | Bionomy, Inc. | 1981-06-30 |