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Recall

Class III — LeMaitre Vascular, Inc.

Recalling firmLEMAITRE VASCULAR, INC.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass III
StatusTerminated
ReasonMislabeled with an incorrect expiration date
ProductLeMaitre 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
Quantity54 units
DistributionCA, CO, KS, MN, UT, WA, WI
Initiated2015-02-24
Classified2015-03-18
Terminated2015-05-21
Recall numberZ-1294-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class III recall — LeMaitre Vascular, Inc. (Z-1294-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70698/

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