Device recall

Z-1072-2009: Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: M00456600…

FDA device recall · Class II · Boston Scientific Corp

Key facts

Recall number (Z-number) Z-1072-2009
Recall event 50771
Product Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: M00456600, M00456610, M00456620, M00456630, M00456650, M00456700, M00456710 and M00456760. Manufactured by Thomas Medical Products, Inc. Product is intended for use to facilitate the percutaneous introduction of various types of…
Product code DYB
Recalling firm Boston Scientific Corp
Recall class Class II
Status Terminated
Termination date Apr 6, 2010
510(k) numbers K013866, K022067, K034061, K072719
FEI number 3001236349

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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