Recall Z-0328-2008 ยท DYB Introducer, Catheter
Boston Scientific Corp
Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol Guidewire, sterile, REF/Catalog No. 20-710; UPN/Material Number: M001207100, Boston Scientific Corporation, Natick, MA 01760
| Date | Dec 7, 2007 (initiated Jul 19, 2007) |
| Status | Terminated |
| Reason | Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 249 (199 U.S.A. plus 50 international) |
| Distribution | Worldwide: USA and The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952828 | MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM Boston Scientific Corp, Aug 18, 1995 |