Device recall

Z-1470-2008: Replacement Kit, Power PCBA, REF 17345-001. only distributed outside the US…

FDA device recall · Class II · Cardinal Health 203, Inc

Key facts

Recall number (Z-number) Z-1470-2008
Recall event 46850
Product Replacement Kit, Power PCBA, REF 17345-001. only distributed outside the US. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.
Product code CBK
Recalling firm Cardinal Health 203, Inc
Recall class Class II
Status Terminated
Termination date Aug 16, 2012
510(k) numbers K002881, K040540, K981371, K984056
FEI number 3002617992

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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