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Terminated

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

FDA Recall Z-0328-2008 · Posted 2007-12-07

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeDYB
Date Initiated2007-07-19
Date Terminated2008-02-17
Product Quantity249 (199 U.S.A. plus 50 international)

Reason for Recall

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

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide: USA and The Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K952828MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEMBoston Scientific Corp · 1995-08-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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