Device recall

Z-1713-2014: Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer…

FDA device recall · Class II · Arrow International Inc

Key facts

Recall number (Z-number) Z-1713-2014
Recall event 68073
Product Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
Product code DYB
Recalling firm Arrow International Inc
Recall class Class II
Status Terminated
Termination date Oct 14, 2016
510(k) numbers K780532
FEI number 3015859709

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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