Recalling Firm / Manufacturer

Ev3, Inc

Product

Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EO ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA THE ENDOVASCULAR COMPANY. The Snare Kit contains a pouch labeled a "Snare Catheter" and a pouch labeled "Amplatz Goose Neck Snare". Snare Catheter

Code Information

Lot # 1650307

Reason of Recall

Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr.

Date Recall Initiated

May 18, 2007

Action

Letter May 18, 2007. Firm Initiated recall is ongoing

Contact

PINJ Medical Technology Company
Riyadh
(01) 2197744

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.