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
- Company
- Lemaitre Vascular, Inc.
- Recall Initiated
- February 24, 2015
- Posted
- March 18, 2015
- Terminated
- May 21, 2015
- Recall Number
- Z-1294-2015
- Quantity
- 54 units
- Firm Location
- Burlington, MA
Reason for Recall
Mislabeled with an incorrect expiration date
Distribution
CA, CO, KS, MN, UT, WA, WI
Lot / Code Info
Lot Number: 61049252 Exp. Date: 2016-06
Root Cause
Employee error
Action Taken
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
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