Recall Z-0561-05 ยท DXE Catheter, Embolectomy
Lemaitre Vascular, Inc.
LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml , Length 80 cm Latex Product Number: 1601-28
| 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 | 312 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
This recall record lists no 510(k) number.