Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations whic
FDA device recall Z-1111-2013 · posted 2013-04-14 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- Reason for recall
- Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.
- Action taken
- Edwards Lifesciences sent an Urgent Field Safety Notice letter dated March 28, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of any affected product remaining in inventory and to return any unused devices to Edwards. A completed Acknowledgement Form should be faxed to Edwards at 800-422-9329 within three days of receiving the notice. Questions regarding the recall should be directed to Edwards Customer Services at 800-424-3278, 6:00AM - 4:30PM PST.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 379 units
- Distribution
- USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.
- Date initiated
- 2013-03-14
- Date posted
- 2013-04-14
- Date terminated
- 2016-03-08
- 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 |