Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist.
FDA Recall Z-0303-2012 · Posted 2011-11-29
Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDWB
Date Initiated2011-10-21
Date Terminated2012-02-17
Product Quantity10 units
Reason for Recall
Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was shipped to a single customer. The affected board mislabeled two connection between the board and the transformer.
Firm Action
Terumo conducted a Correction/Removal - Customer Communicated Script on November 7, 2011 to the affected customer. The phone script communicated the correction and reason for removal, potential hazards, affected population, and confirmation of possession of affected module. A replacement date was set for November 7, 2011. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818, hours are Monday to Friday. 8 AM -6 PM EST.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution (USA) including the state of San Antonio, TX
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.