Recall Z-2545-2016
LeMaitre Vascular, Inc. · initiated August 3, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
Codes / lots: Lot Number Exp Date ELVH1089V¿ 2021-03 ELVH1091V 2021-03¿
Reason for recall
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
FDA-determined cause: Process control
Action taken
LeMaitre Vascular, Inc. sent an Urgent Medical Device Recall letter dated June 29, 2016 to customers via priority mail. The letter identified the affected product, problem and actions to be taken. Customers were requested to locate, quarantine and return the devices. Customers were instructed to complete and return the response form to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product will be requested to be returned and replaced. For questions call 781-221-2266 ext. 183.
Details
- Recall number
- Z-2545-2016
- Initiated
- August 3, 2016
- Terminated
- April 8, 2021
- Product code
- MGZ – Valvulotome
- Quantity
- 50 units
- Distribution
- Worldwide Distribution - US Nationwide and in the countries of Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.
- Recalling firm
- LeMaitre Vascular, Inc., Burlington, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2543-2016 Class II | 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO…Wire which deploys the loop may be come detached at the handle causing the device to be inoperable | 08/03/2016Terminated |
| Z-2544-2016 Class II | 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product…Wire which deploys the loop may be come detached at the handle causing the device to be inoperable | 08/03/2016Terminated |