Z-1054-2013Class II

LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed...

Name: Z-1054-2013 LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed...
Creator: LeMaitre Vascular, Inc.
Published: 2013-03-18
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2013-03-18 / Terminated / root cause: packaging

FDA source

LeMaitre Vascular, Inc. began a recall of 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 on 2013-03-18. FDA classified it as Class II and gives the reason as "Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1054-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-18
Posted: 2013-04-04
Terminated: 2014-12-03
Recalling firm: LeMaitre Vascular Inc.
Product: 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.
Product code: KFX Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Reason for recall: Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
Root cause tag: packaging
FDA 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 in commerce: 6970
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
Product codes and lots: LSG1130, exp. 2017-04; LSG1132, exp. 2017-11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1054-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1054-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-04
Z-1055-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-04

Product code KFX

K932184Class IISterile Lemaitre Glow 'N Tell TapeVascutech, Inc. / cleared 1993-07-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)