Recall record at a glance
| Official record | Z-2544-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | LeMaitre Vascular, Inc. |
| Report date | Aug 24, 2016 |
| Recall initiation date | Aug 3, 2016 |
| Quantity | 380 units |
| Location | Burlington, MA, United States |
Official product description
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
Why the product was recalled
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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