AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN
FDA device recall Z-0703-2007 · posted 2007-04-03 · Terminated
Recall details
- Recalling firm
- American Medical Systems
- Reason for recall
- Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.
- Action taken
- The consignees were notified of the recall by letter starting Feb 7, 2007. Consignees were asked to return product to American Medical Systems.
- Root cause
- Other
- Status
- Terminated
- Product code
- FAE
- Quantity affected
- 5 devices
- Distribution
- Nationwide
- Date initiated
- 2007-02-19
- Date posted
- 2007-04-03
- Date terminated
- 2007-06-27
- Location
- Minnetonka, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DUNA II PENILE PROSTHESIS (K953640) | Dacomed Corp. | 1995-10-27 |