Recall Z-0382-2016 ยท DXE Catheter, Embolectomy
LeMaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
| Date | Dec 4, 2015 (initiated Oct 21, 2015) |
| Status | Terminated |
| Reason | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. |
| Root cause | Packaging process control |
| Action | Consignees were notified of the recall on October 21, 2015 via letter. Consignees were asked to do the following: Identify all catheters with the affected LOT and model numbers in inventory; quarantine all unused catheters from the affected LOTs and record this action in the attached form; send the form via mail, email or fax to Customer Service who will then issue an RMA-number (Return Merchandise Authorization number) for the return shipment and replacement of the products; pass this notice on to all those who need to be aware within your organization and to any organization to which the p |
| Quantity | 4315 total |
| Distribution | Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switz |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022145 | OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 LeMaitre Vascular, Inc., Jan 14, 2003 |