Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 2
FDA device recall Z-1467-2014 · posted 2014-04-16 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- Reason for recall
- Potential for separation of dilator tips.
- Action taken
- Customers were notified via letter on 4/4/14 to return affected products.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 28,885
- Distribution
- Nationwide, including foreign, govt/VA/Military consignees.
- Date initiated
- 2014-04-09
- Date posted
- 2014-04-16
- Date terminated
- 2016-12-28
- Location
- Draper, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING (K123298) | Edwards Lifesciences, LLC | 2013-03-15 |