Edwards Lifesciences LLC, Fem-Flex II Duraflo Treated Femoral Venous Catheter, 8 Fr. x 11.5 cm, REF DIIFEMII008V, Cardio
FDA device recall Z-1894-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences Research Medical, Inc.
- Reason for recall
- Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass, which would result in a more significant delay and has the potential to result in a permanent injury.
- Action taken
- Consignees were notified by Edwards Lifesciences sales representatives and a Product Recall letter dated 2/22/08. Users were instructed to check their inventory for any affected product and to return all unused product to the recalling firm. Users were also requested to return a recall response form indicating the quantity of affected product.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 10 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-02-25
- Date posted
- 2008-09-11
- Date terminated
- 2008-09-16
- 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 |
|---|---|---|
| EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE (K033464) | Edwards Lifesciences, LLC | 2004-06-22 |
| FEM-FLEX FEMORAL ACCESS CANNULATION SET (K891576) | Research Medical, Inc. | 1989-10-12 |