—#88312

Product

EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight Maquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470

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: Product Code: M002004910580; Lot # 12633379, Exp: 4/2012

Why it was recalled

Labeling mix up: Shelf Carton label for Exxcel Soft Thin Wall Vascular Grafts, lot # 12633379 were mislabeled as Exxcel Soft Standard Wall Grafts. Bleeding could occur if wrong product is used.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Recall letters were sent to all US customers on January 20, 2010 by certified mail. Letters for foreign consignees were to be sent as soon as translation was completed. Customer are directed to call the company at 973-709-7515 for more information.

Recalling firm

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

Distribution

Distribution pattern: Product was distributed to hospitals in TX, TN, CT, AR, AZ as well as to Austria and France.

Timeline

Recall initiated: 2010-01-20
Posted by FDA: 2010-02-26
Terminated: 2010-07-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88312. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.