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
This recall has been terminated (originally issued December 7, 2007).
- Company
- Boston Scientific Corp
- Recall Initiated
- July 19, 2007
- Posted
- December 7, 2007
- Terminated
- February 17, 2008
- Recall Number
- Z-0328-2008
- Quantity
- 249 (199 U.S.A. plus 50 international)
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use.
Distribution
Worldwide: USA and The Netherlands.
Lot / Code Info
Lot /Batch Number: 9498023.
Root Cause
Process control
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.
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