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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Number Exp Date ELVH1078V¿ 2020-10 ELVH1079VA 2020-10
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
LeMaitre Vascular, Inc.
Reason for Recall:
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

Lot Number Exp Date ELVH1078V¿ 2020-10 ELVH1079VA 2020-10

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2544-2016

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Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

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