—#90544

Product

EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Wall Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries.

FDA product code: DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K052964
Affected lot / code info: UPN M002004810260; Lot 11423751; Exp 12/2010

Why it was recalled

This is an expansion of Recall # Z-866-2010, adding an additional two lots to the recall of EXXCEL soft Stand Wall EPTFE Vascular Grafts due to a labeling mix up.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

The firm, MAQUET Cardiovascular, LLC, sent a "DEVICE REMOVAL IMMEDIATE ACTION REQUIRED" letter dated March 23, 2010, to all customers via Federal Express. The letter describes the product, problem and action to be taken by customers. The customers were instructed to examine their stock immediately to determine if they have any of the affected product from the lot, discontinue dispensing the lot and complete and return by fax (973-709-6511) the enclosed Field Action Response Form whether or not they have any affected products. Please contact your local MAQUET cardiovascular sales representative or Customer Service at 1-888-880-2874 for the exchange.

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: Worldwide distribution: USA including states of TX, NJ, SC, MO, ID, TN, FL, CA, PA and Canada and Germany.

Timeline

Recall initiated: 2010-03-26
Posted by FDA: 2010-05-14
Terminated: 2012-04-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90544. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.