FDA Device

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

Hazard

Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use.

What You Should Do

Remedy

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.

Products

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 Scientif
Brand
Boston Scientific Corp
UPC
Lot /Batch Number: 9498023.

Units Affected

249 (199 U.S.A. plus 50 international)