Device recall

Z-1162-2018: Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue…

FDA device recall · Class II · Arrow International Inc

Key facts

Recall number (Z-number) Z-1162-2018
Recall event 79342
Product Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
Product code FOZ
Recalling firm Arrow International Inc
Recall class Class II
Status Terminated
Termination date Jul 15, 2019
510(k) numbers K071538
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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