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
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