Date Initiated by Firm | February 24, 2015 |
Date Posted | March 18, 2015 |
Recall Status1 |
Terminated 3 on May 21, 2015 |
Recall Number | Z-1294-2015 |
Recall Event ID |
70698 |
510(K)Number | K041453 |
Product Classification |
Stripper, vein, external - Product Code DWQ
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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 |
Code Information |
Lot Number: 61049252 Exp. Date: 2016-06 |
Recalling Firm/ Manufacturer |
LeMaitre Vascular, Inc. 63 2nd Ave Burlington MA 01803-4413
|
For Additional Information Contact | Laurie Churchill 781-425-1670 Ext. 108 |
Manufacturer Reason for Recall | Mislabeled with an incorrect expiration date |
FDA Determined Cause 2 | Employee error |
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 |
Quantity in Commerce | 54 units |
Distribution | CA, CO, KS, MN, UT, WA, WI |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DWQ
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