Recall Z-1294-2015
LeMaitre Vascular, Inc. · initiated February 24, 2015
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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
Codes / lots: Lot Number: 61049252 Exp. Date: 2016-06
Reason for recall
Mislabeled with an incorrect expiration date
FDA-determined 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
Details
- Recall number
- Z-1294-2015
- Initiated
- February 24, 2015
- Posted by FDA
- March 18, 2015
- Terminated
- May 21, 2015
- Product code
- DWQ – Stripper, Vein, External
- Quantity
- 54 units
- Distribution
- CA, CO, KS, MN, UT, WA, WI
- Recalling firm
- LeMaitre Vascular, Inc., Burlington, MA