Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 90cm usable length, Material Number (
FDA device recall Z-0259-2008 · posted 2007-11-24 · Terminated
Recall details
- Recalling firm
- Boston Scientific Target
- Reason for recall
- Mislabeling: Catheters were found to be mislabeled (90 cm labeled devices actually contains 100 cm length catheter)
- Action taken
- Firm notified consignees by Urgent Medical Device Recall Letter dated 11 Jul 07 requesting return of product.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 47 units
- Distribution
- Worldwide Distribution-USA, EU, Japan, South Korea, Mexico, Colombia, and Hungary.
- Date initiated
- 2007-07-11
- Date posted
- 2007-11-24
- Date terminated
- 2007-12-05
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS (K980453) | Boston Scientific Scimed, Inc. | 1998-08-11 |