Device recall

Z-0468-2014: Arrow Transradial Artery Access products Arrow Transradial Artery Access…

FDA device recall · Class II · Arrow International Inc

Key facts

Recall number (Z-number) Z-0468-2014
Recall event 66586
Product Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
Product code DYB
Recalling firm Arrow International Inc
Recall class Class II
Status Terminated
Termination date Aug 12, 2015
510(k) numbers K112554, 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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