Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x .018'',0.46mm) and SK701 (200 cm length
FDA device recall Z-0894-06 · posted 2006-06-02 · Terminated
Recall details
- Recalling firm
- Ev3, Inc
- Reason for recall
- ev3 has determined that one test unit from each of two lots did not meet mininum tensile strength requirements and therefore the entire lots are being recalled.
- Action taken
- The recall was initiated on August 16, 2005. All units distributed have been accounted for and the firm completed the recall on December 29, 2005. The firm sent a notification to customers with a Device Recall Field Action Form to record if devices remain at the sight and include with devices returned for credit or replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXE
- Quantity affected
- 58
- Distribution
- AL, AR, CA, CO, FL, IL, KS, MA, MO, NY, PA, TX, WA, VA, Canada, Germany, Japan
- Date initiated
- 2005-08-16
- Date posted
- 2006-06-02
- Date terminated
- 2006-12-26
- 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 (K901502) | Microvena Corp. | 1990-12-03 |