FDAClass IISeptember 6, 2023

The Chevalier Valvulotome is a device used to disrupt recall

The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass…

Why was The Chevalier Valvulotome is a device used to disrupt recalled?

Burrs (molding flash) on the cutter may tear the harvested vien

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

(1)Catalog # 40025 UDI-DI: 00840663110469; (2)Catalog # 40030 UDI-DI: 00840663110476; (3) Catalog # 40035 UDI-DI: 00840663110483 Lot Numbers: All lots starting with CHV. Only lots beginning with CHV are being recalled. Older lots (with CL lot prefixes) are not being recalled. REF (Catalog #) LOT Catalog Number: (1)40025 Lot Number: CHV1003, CHV1006, CHV1022 (2) 40030 Lot Number: CHV1002, CHV1004, (3) 40035 Lot Number: CHV1001, CHV1005

Product
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass…
Recalling firm
LeMaitre Vascular, Inc.
Quantity
225 units
Distribution
International distribution to the countries of Belgium, France, Germany, and United Kingdom.
Recall date
September 6, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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