Device recall

Z-2683-2011: Terumo Cardiovascular Systems, CDI 101 Hematocrit/Oxygen saturation monitoring…

FDA device recall · Class II · Terumo Cardiovascular Systems Corporation

Key facts

Recall number (Z-number) Z-2683-2011
Recall event 58532
Product Terumo Cardiovascular Systems, CDI 101 Hematocrit/Oxygen saturation monitoring system, catalog 101.
Product code DRY
Recalling firm Terumo Cardiovascular Systems Corporation
Recall class Class II
Status Terminated
Termination date Aug 6, 2012
510(k) numbers K902654
FEI number 1828100

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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