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Recall Observatory FDA recall evidence

Device product

Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

Z-0052-2013

September 24, 2012

Class II

Product summary

Firm
Terumo Cardiovascular Systems Corporation
Event
Event 62059
Status
Terminated
Classification
Class II
Quantity
213 units
Official record key
device-enforcement:Z-0052-2013

Official wording

Reason: Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.

Code information: Catalog number: 6380 and serial numbers: 5007, 5028-5030, 5032, 5075, 5076, 5135,6010,6013,6025,6030,6116, 7000-7197,7372, and 7373.

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Bangladesh, Seoul Korea, Chile, Brazil, Venesuela, Thailand, Mexico, India, Taiwan, Canada, Dominican Republic, Guatemala, Ecuador, Germany, Republic of Georgia, Hong Kong, Japan, United Arab Emirates (UAE), Japan, Belgium, Phillipines, Singapore, and South Africa.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.