Device recall

Z-2260-2017: Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard…

FDA device recall · Class II · Arrow International Inc

Key facts

Recall number (Z-number) Z-2260-2017
Recall event 76937
Product Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions. The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter…
Product code FOZ
Recalling firm Arrow International Inc
Recall class Class II
Status Terminated
Termination date Dec 18, 2018
510(k) numbers K002507
FEI number 3015859709

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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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