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Terminated

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

FDA Recall Z-1294-2015 · Posted 2015-03-18

Recalling FirmLeMaitre Vascular, Inc.
Recall StatusTerminated
Product CodeDWQ
Date Initiated2015-02-24
Date Terminated2015-05-21
Product Quantity54 units

Reason for Recall

Mislabeled with an incorrect expiration date

Firm Action

LeMaitre Vascular issued a Field Safety Notice/Dear Doctor dated 2/24/15 to customers The letter provides information on the recalled product and instructions on how the customer can inspect for the defective devices and return the affected products for replacement/credit. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Questions, contact 781-221-2266 ext. 183

Root Cause

Employee error

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041453SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023Smith & Nephew, Inc. · 2004-07-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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