Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EO ev3 4600 Nathan Lane North,
FDA device recall Z-0992-2007 · posted 2007-07-11 · Terminated
Recall details
- Recalling firm
- Ev3, Inc
- Reason for recall
- Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr.
- Action taken
- Letter May 18, 2007.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXE
- Quantity affected
- 23 units
- Distribution
- Worldwide, including USA, Belgium, France, Germany, Italy, Jordan, Spain, United Kingdom, and Yemen.
- Date initiated
- 2007-05-18
- Date posted
- 2007-07-11
- Date terminated
- 2008-10-17
- Location
- Plymouth, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMPLATZ GOOSE NECK SNARE KIT/ CATHETER (K972511) | Microvena Corp. | 1998-03-06 |