The Recall Desk

FDA (Devices) recall action 63381

Sorin Group USA, Inc. recalled 2 products on 2012-11-07

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-11-07
Critical
0
Units
—

Why these products were recalled

Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board component within the Panel may lead to a malfunction consisting of a blank or flashing display. The flow and pressure display information may also be incorrect after the malfunction.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2012-11-07

    Sorin SCP Pump Control Panel Recalled for Display Malfunction

    Sorin Group USA is recalling 12 SCP Pump Control Panels due to a circuit board defect that may cause display malfunctions and incorrect flow or pressure readings.

    Product
    SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardio
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2012-11-07

    Sorin SCP Pump Control Panel Recalled for Circuit Board Malfunction

    Sorin Group USA is recalling SCP Pump Control Panels due to a circuit board defect that may cause display malfunctions and incorrect flow or pressure readings.

    Product
    SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping thro
    Category
    Distribution
    2 states