Device recall

Z-1331-2018: (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2)…

FDA device recall · Class II · Arrow International Inc

Key facts

Recall number (Z-number) Z-1331-2018
Recall event 79512
Product (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550-NYP
Product code DQY
Recalling firm Arrow International Inc
Recall class Class II
Status Terminated
Termination date May 27, 2020
510(k) numbers K820009
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

Browse all FDA device recalls (products)