Device recall

Z-0140-06: Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal…

FDA device recall · Class II · Terumo Cardiovascular Systems Corp

Key facts

Recall number (Z-number) Z-0140-06
Recall event 32923
Product Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump The centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A. The devices are assembled with PVC tubing and other devices according to individual customer specifications and then packaged into Custom…
Product code KFM
Recalling firm Terumo Cardiovascular Systems Corp
Recall class Class II
Status Terminated
Termination date May 2, 2006
510(k) numbers K962981
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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