Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre
FDA device recall Z-0219-06 · posted 2005-11-30 · Terminated
Recall details
- Recalling firm
- LeMaitre Vascular, Inc.
- Reason for recall
- LeMaitre Vascular is recalling certain lots of its Pruitt Aortic Occlusion Catheters due to a packaging defect which could compromise product sterility.
- Action taken
- The distributors in Europe and Japan have been notified to contact their customers to return the products. All customers have been notified by letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQT
- Quantity affected
- 1,919
- Distribution
- There are two lots in distribution (175 pieces) that may contain the small hole in the tray. These two lots were distributed in Japan and Europe. There are 16 lots in distribution (1,744 pieces) that
- Date initiated
- 2005-05-17
- Date posted
- 2005-11-30
- Date terminated
- 2012-07-06
- Location
- St Petersburg, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT (K872090) | Ideas For Medicine, Inc. | 1987-10-30 |