Recall Z-1294-2015— LeMaitre Vascular, Inc.

Name: FDA recall Z-1294-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-24

Class III · Terminated

Class III FDA medical device recall by LeMaitre Vascular, Inc., initiated 2015-02-24, terminated 2015-05-21. It names one FDA 510(k) clearance: K041453. Product: LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252. Reason: Mislabeled with an incorrect expiration date.

Recalling firm: LeMaitre Vascular, Inc.
Classification: Class III
Status: Terminated
Initiated: 2015-02-24
Terminated: 2015-05-21
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K041453 — SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023Smith & Nephew, Inc.·cleared 2004-07-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252

Reason for recall

Mislabeled with an incorrect expiration date

Data sourced from openFDA. This site is unofficial and independent of the FDA.