Recall Z-0558-05 ยท DXE Catheter, Embolectomy
Lemaitre Vascular, Inc.
LeMaitre Embolectomy Catheter 3F Single Lumen, Balloon volume 0.2ml, Length 80 cm, Latex Model: 1601-38
| Date | Feb 24, 2005 (initiated Feb 7, 2005) |
| Status | Terminated |
| Reason | Product sterility maybe compromised due to defective packaging |
| Root cause | Other |
| Action | LaMaitre notified consignees by lettter advising users to check inventory and return defective product. |
| Quantity | 692 units |
| Distribution | AL, CA, FL, IN, MD, MI,NY, TN, FOREIGN: Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992368 | LEMAITRE EMBOLECTOMY CATHETER Vascutech, Inc., Dec 9, 1999 |