Recall Z-0219-06 ยท DQT Occluder, Catheter Tip
LeMaitre Vascular, Inc.
Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufactured By: LeMaitre Vascular, Inc. 3101 37th Avenue North St. Petersburg, FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***''.
| Date | Nov 30, 2005 (initiated May 17, 2005) |
| Status | Terminated |
| Reason | LeMaitre Vascular is recalling certain lots of its Pruitt Aortic Occlusion Catheters due to a packaging defect which could compromise product sterility. |
| Root cause | Other |
| Action | The distributors in Europe and Japan have been notified to contact their customers to return the products. All customers have been notified by letter. |
| Quantity | 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 utilize the trays with the thin spots that can potentially crack. These 16 lots were distributed |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K872090 | THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT Ideas For Medicine, Inc., Oct 30, 1987 |