Sorin Group USA, Inc.: 2 S5 Mast Roller Pumps 85 with Double Holder, S5 Component, Part No.: 50-80-62, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

Recall number

Z-0962-2011

Recalling firm

Sorin Group USA, Inc.

Product

2 S5 Mast Roller Pumps 85 with Double Holder, S5 Component, Part No.: 50-80-62, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

Status

Terminated

Initiated

2010-11-12

Posted

2011-01-26

Terminated

2012-07-13

Reason

Touch screen may become unresponsive, inhibiting user input.

Root cause

Device Design

Action

All affected US customers and distributors were notified by certified mail on Nov 12, 2010 via a Field Correction letter. They were told that they would be contacted by Sorin to arrange an appointment to inspect and replace affected touch screens on site. They were told that they could safely continue using their S5 systems in accordance with the Operator's Manual and previously supplied instructions until the inspection and necessary replacement had been completed. A customer response form was also included for completion and return to the firm. Customers can contact the firm if they have any questions.

Quantity

65 units

Distribution

Worldwide Distribution.

Lot, serial or model codes

Serial Numbers: 50E50153, 50E0154, 50K00332 to 50K00685.

510(k) numbers

["K060053"]

PMA numbers

not on file

Product code

DTQ

Firm FEI

1718850

Firm city

Arvada

Firm state

CO

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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