Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0992-2007

Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EO ev3 4600 Nathan...

Medtronic, Inc. / initiated 2007-05-18 / Terminated

Ev3, Inc began a recall of Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By , Sterile EO ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA THE... on . The reason FDA records is "Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0992-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic, 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
Product code
DXE Catheter, Embolectomy
Reason for recall
Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr.
FDA root cause
Other
Action
Letter May 18, 2007.
Quantity in commerce
23 units
Distribution
Worldwide, including USA, Belgium, France, Germany, Italy, Jordan, Spain, United Kingdom, and Yemen.
Product codes and lots
Lot # 1650307