Duraflo Treated Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm., Edwards Lifesciences
FDA device recall Z-1090-06 · posted 2006-06-09 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences Research Medical, Inc.
- Reason for recall
- Due to potential embrittlement of the plastic tip which may crack or separate during use.
- Action taken
- Consignees were notified by letter and visit beginning 04/18/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 50 units (Foreign)
- Distribution
- CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan
- Date initiated
- 2006-04-18
- Date posted
- 2006-06-09
- Date terminated
- 2008-06-11
- Location
- Midvale, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIOUS CARDIOVASCULAR SURGICAL DEVICE (K831769) | Research Industries Corp. | 1983-08-12 |