Terumo Sarns Centrifugal System Control Module Recalled for Power Loss
Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a loss of power to a critical life-support device during a surgical procedure, which constitutes a significant injury risk.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling Sarns Centrifugal System Control modules, 100/115V. The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. The recall involves 847 units with catalog number 6379 and specific serial numbers listed in the agency record.
The recall was initiated after Terumo CVS received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during a cardiopulmonary bypass procedure. The affected units were distributed worldwide, including the United States and various international locations.
Healthcare facilities and users should identify any affected units by checking the catalog and serial numbers against the recall list. Users should stop using the affected control modules and contact Terumo CVS for further instructions.
The recalled product
- Product
- Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 847
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog number: 6379 and serial numbers: 942
- 1003-1006
- 1034
- 1039
- 1051
- 1056
- 1087
- 1914
- 3030
- 4019
- 4344
- 5009
- 5012
- 5013
- 5030
- 5048
- 5059
- 5062
- 5080
- 5096
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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