Device recall

Z-0401-2018: CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the…

FDA device recall · Class II · Sorin Group Deutschland GmbH

Key facts

Recall number (Z-number) Z-0401-2018
Recall event 78594
Product CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.
Product code DWA
Recalling firm Sorin Group Deutschland GmbH
Recall class Class II
Status Terminated
Termination date Jan 26, 2024
510(k) numbers K112225
FEI number 3002808267

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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