Device recall

Z-2618-2016: Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in…

FDA device recall · Class II · Cook Inc.

Key facts

Recall number (Z-number) Z-2618-2016
Recall event 74010
Product Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach.
Product code FCG
Recalling firm Cook Inc.
Recall class Class II
Status Terminated
Termination date Aug 4, 2017
FEI number 1820334

At a glance

  • None Linked 510(k)s
  • 10–99 Products in the same recall event
  • 10–99 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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