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.
FDA Recall Z-1054-2013 · Posted 2013-04-04
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Recalling FirmLeMaitre Vascular, Inc.
Recall StatusTerminated
Product CodeKFX
Date Initiated2013-03-18
Date Terminated2014-12-03
Product Quantity6970
Reason for Recall
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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