SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SRD S5 TWO MAST ROLLER PUMPS, Made in Germany

FDA device recall Z-1155-2012 · posted 2012-03-05 · Terminated

Recall details

Recalling firm

Sorin Group USA, Inc.

Reason for recall

Touch screen may be unresponsive, inhibiting user input.

Action taken

All affected US customers and distributors were notified of the Sorin S5 HLM Touch Screen Field Correction by certified mail on 02/15/12. The letter informed users of the potential for unresponsive S5 HLM touch screens and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to replace affected touch screens on site. Customers and distributors were also provided with a Response Form to confirm they had received, read and understood the Field Correction Notice. They were instructed to fax the completed form to (303) 467-6502. For questions regarding this recall call 303-467-6306.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

DTQ

Quantity affected

2 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Belgium, Bulgaria, China, Denmark, Germany, Ecuador, Egypt, Finland, France, Georgia, Greece, United Kingdom, Hong

Date initiated

2012-02-16

Date posted

2012-03-05

Date terminated

2012-11-09

Location

Arvada, CO

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