Recall Z-1294-2015 ยท DWQ Stripper, Vein, External
LeMaitre Vascular, Inc.
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
| Date | Mar 18, 2015 (initiated Feb 24, 2015) |
| Status | Terminated |
| Reason | Mislabeled with an incorrect expiration date |
| Root cause | 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 | 54 units |
| Distribution | CA, CO, KS, MN, UT, WA, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041453 | SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 Smith & Nephew, Inc., Jul 22, 2004 |