FDAFDA · Food and drugs·Recall number Z-2544-2016
1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
Published August 24, 2016 · Recall initiated: August 3, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- LeMaitre Vascular, Inc.
- Distributor
- 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.
- Lot
- Lot Number Exp Date ELVH1078V¿ 2020-10 ELVH1079VA 2020-10
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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