||April 04, 2013
||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.
||LSG1130, exp. 2017-04; LSG1132, exp. 2017-11
|LeMaitre Vascular, Inc.
63 2nd Ave
Burlington, Massachusetts 01803-4413
|For Additional Information Contact
781-221-2266 Ext. 108
|Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
||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 in Commerce
||Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.