Recall Z-1054-2013 ยท KFX Assembly, Thigh/Knee/Shank/Ankle/Foot, External
LeMaitre Vascular, Inc.
LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
| Date | Apr 4, 2013 (initiated Mar 18, 2013) |
| Status | Terminated |
| Reason | Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised. |
| Root cause | Packaging process control |
| Action | LeMaitre sent an "URGENT:VASCUTAPE RADIOPAQUE TAPE DEVICE FIELD SAFETY NOTICE" dated March 20, 2013 to affected customers. The recall letter contains a form that requests customers to return to LeMaitre Vascular, Inc. as a record of notification and reconciliation. The letter provides instructions on how the customer can inspect the defective tape seals and/or return the affected products for replacement/credit. |
| Quantity | 6970 |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932184 | STERILE LEMAITRE GLOW 'N TELL TAPE Vascutech, Inc., Jul 22, 1993 |