Recall Z-0992-2007
Ev3, Inc · initiated May 18, 2007
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
Codes / lots: Lot # 1650307
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-determined cause: Other
Action taken
Letter May 18, 2007.
Details
- Recall number
- Z-0992-2007
- Initiated
- May 18, 2007
- Posted by FDA
- July 11, 2007
- Terminated
- October 17, 2008
- Product code
- DXE – Catheter, Embolectomy
- Quantity
- 23 units
- Distribution
- Worldwide, including USA, Belgium, France, Germany, Italy, Jordan, Spain, United Kingdom, and Yemen.
- Recalling firm
- Ev3, Inc, Plymouth, MN