Sterile LeMaitre Glow 'N Tell Tape

• 2 recalls, same reason

  • Terminated Z-1055-2013 FDA Class II ·initiated 18 Mar 2013
  • Terminated Z-1054-2013 FDA Class II ·initiated 18 Mar 2013

  Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.

• 4 recalls, same reason

  • Terminated Z-0435-2011 FDA Unclassified (pre-2012) ·initiated 22 Oct 2010 ·on shared 510(k) K932184
  • Terminated Z-0436-2011 FDA Unclassified (pre-2012) ·initiated 22 Oct 2010 ·on shared 510(k) K932184
  • Terminated Z-0433-2011 FDA Unclassified (pre-2012) ·initiated 22 Oct 2010 ·on shared 510(k) K932184
  • Terminated Z-0434-2011 FDA Unclassified (pre-2012) ·initiated 22 Oct 2010 ·on shared 510(k) K932184

  Box label (Top Part). Lot and Expiration Date information were switched.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K932184 ↗

FDA Product Code

KFX

Device Class

Class II

Regulation

21 CFR Part 890.3500

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Lemaitre Irrigation Catheter

  Class II

  FDA 510(k) K992933 Active Cleared 8 Mar 2000

• LeMaitre Occlusion Catheter

  Class II

  FDA 510(k) K992942 Active Cleared 13 Apr 2000

• Lemaitre-Bookwalter Vessel Devices

  Class II

  FDA 510(k) K912548 Active Cleared 18 Sep 1991

• Lemaitre Embolectomy Catheter Open recall

  Class II

  FDA 510(k) K992368 Active Cleared 9 Dec 1999

• Lemaitre Balloon Catheter with Irrigation

  Class II

  FDA 510(k) K992940 Active Cleared 22 Feb 2000

• The Samuels Retrograd Valvulotome

  Class II

  FDA 510(k) K932009 Active Cleared 21 Sep 1993

See all devices from Vascutech, Inc. →

• What is the LeMaitre Glow 'N Tell Tape used for?

  This sterile radiopaque tape is designed for external use on the thigh, knee, shank, ankle, and foot. It provides precise vascular imaging during procedures by creating visible markings on fluoroscopy and the patient's skin, helping to locate fistulae and minimize incision size.

• How is the LeMaitre Glow 'N Tell Tape supplied?

  The tape is supplied in sterile strips and is intended for single-use applications only. Each strip contains radiopaque markings that are visible during fluoroscopic imaging procedures.

• What procedures is this tape commonly used in?

  This tape is used in physical medicine procedures such as in situ vein bypass and plaque excision. It creates a roadmap of lesions and helps locate fistulae, allowing for more precise surgical interventions with smaller incisions.

• What is the regulatory status of the LeMaitre Glow 'N Tell Tape?

  The device has FDA 510(k) clearance with product code KFX and is classified as a Class II medical device. It was cleared through the traditional clearance pathway with a decision code of SESE (Substantially Equivalent) on July 22, 1993.