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SCP Pump Control Panel, Product Code: 60-02-15, Serial… recallZ-0166-2013 · Sorin Group USA, Inc. · initiated Sep 20, 2012

Class II Terminated All recalls posted in October 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Sorin Group USA, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Mixed-up of materials/components

What the company is doing

The firm, Sorin Group USA, Inc., sent an "URGENT FIELD SAFETY NOTICE" dated September 20, 2012 to all affected customers by certified mail. The notice described the product, problem and actions to be taken. Customers were instructed to discontinue use of and segregate affected product for return and replacement to the firm; to complete and return the attached Customer Response Form via fax to: 303-467-6502 or email to: [email protected]; and if they have transferred the affected products to a third party, to pass this information to the Sorin Group. Further questions may be directed to Sorin Group Customer Service at 1-800-650-2623.

Recall details

Recall number
Z-0166-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 20, 2012
Posted by the FDA
Oct 29, 2012
Recalling firm
Sorin Group USA, Inc.
Quantity
12 units (3 units USA and 9 units OUS)
Product code
DWA
FDA submissions
K011838
Distribution
Worldwide distribution: USA (nationwide) including states of : MI and NY; and countries of: Belgium, Canada, Japan, India, Russia, United Arab Emirates.

Product description

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 cardiopulmonary bypass circuit for typical durations of six hours or less.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

3 devices cleared under K011838 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 63381).

Sources and updates

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