Device recall

Z-0328-2008: Boston Scientific ACCUSTICK II Introducer System with.038 inch Stainless Steel…

FDA device recall · Class II · Boston Scientific Corp

Key facts

Recall number (Z-number) Z-0328-2008
Recall event 38471
Product 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
Product code DYB
Recalling firm Boston Scientific Corp
Recall class Class II
Status Terminated
Termination date Feb 17, 2008
510(k) numbers K952828
FEI number 1828132

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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