LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the remov
FDA device recall Z-1294-2015 · posted 2015-03-18 · Terminated
Recall details
- Recalling firm
- LeMaitre Vascular, Inc.
- Reason for recall
- Mislabeled with an incorrect expiration date
- 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
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DWQ
- Quantity affected
- 54 units
- Distribution
- CA, CO, KS, MN, UT, WA, WI
- Date initiated
- 2015-02-24
- Date posted
- 2015-03-18
- Date terminated
- 2015-05-21
- Location
- Burlington, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 (K041453) | Smith & Nephew, Inc. | 2004-07-22 |