lemaitre vascular, inc.

Labeling mix-up resulting in the incorrect lot outer packaging of product.

The device was incorrectly packed in the wrong size labeled outer packaging.

The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.

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