Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol Guidewire, s
FDA device recall Z-0328-2008 · posted 2007-12-07 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use.
- Action taken
- Consignees were notified via an Urgent Medical Device Recall Letter sent federal express on 7/19/07, which requested them to check their stocks, remove product from inventory, and return the product.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 249 (199 U.S.A. plus 50 international)
- Distribution
- Worldwide: USA and The Netherlands.
- Date initiated
- 2007-07-19
- Date posted
- 2007-12-07
- Date terminated
- 2008-02-17
- Location
- Spencer, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM (K952828) | Boston Scientific Corp | 1995-08-18 |