Reported Aug 24, 2016 · Terminated
1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is…
LeMaitre Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LeMaitre Vascular, Inc. · 63 2nd Ave · Burlington, MA · 01803-4413
Is this the product you have?
1.5 mm HYDRO LeMaitre Valvulotome40 cm. Sterile REF # 1010-00
- Product UsageThe HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
- Lot codes and dates
- Lot Number Exp Date ELVH1089V¿ 2021-03 ELVH1091V 2021-03¿
- Amount recalled
- 50 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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