LeMaitre Vascular Tumescent Catheter Inversion System recalled over labeling errors

Recall date

February 24, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

LeMaitre Vascular, Inc. recalls LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the remo…

Recall number

Z-1294-2015

FDA classification

Class III

Brand / firm

LeMaitre Vascular, Inc.

Sold / distributed

CA, CO, KS, MN, UT, WA, WI

Why it was recalled

Mislabeled with an incorrect expiration date

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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