The Recall Desk
HighFDA (Devices)·Z-0166-2013·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used in cardiopulmonary bypass where incorrect flow and pressure readings could pose a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Sorin Group USA, Inc. has issued an Urgent Field Safety Notice for certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel. The affected units are identified by Product Code 60-02-15 and specific serial numbers including 60S09121, 60S09123-60S09129, and 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 a cardiopulmonary bypass circuit for typical durations of six hours or less.

The recall is due to an out-of-specification circuit board component within the panel. This defect may lead to a malfunction characterized by a blank or flashing display. Additionally, the flow and pressure display information may be incorrect following such a malfunction.

A total of 12 units are affected, with 3 units distributed in the USA and 9 units distributed outside the USA. The distribution pattern includes the United States (nationwide, including Michigan and New York) and the countries of Belgium, Canada, Japan, India, Russia, and the United Arab Emirates. Users should contact Sorin Group USA, Inc. for further instructions regarding the replacement or repair of these devices.

The recalled product

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
Manufacturer
Sorin Group USA, Inc.
Category
Medical Device — Cardiopulmonary Bypass
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Product Code: 60-02-15
  • Serial Numbers: 60S09121
  • 60S09123-60S09129
  • 60S09136-60S09139.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Sorin Group USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Sorin Group USA, Inc.

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Same hazard · display malfunction

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