—#102865

Product

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 product code: DWB — Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K915183
Affected lot / code info: Catalog Number 16422 Serial Number 1901

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Nationwide Distribution (USA) including the state of San Antonio, TX

Timeline

Recall initiated: 2011-10-21
Posted by FDA: 2011-11-29
Terminated: 2012-02-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #102865. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.