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 classified this as a Class II recall involving a medical device used in life-support procedures (cardiopulmonary bypass). A loss of power to the drive motor during such a procedure represents a significant risk of serious injury, fitting the criteria for a Severe rating.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 126 units of the Sarns Centrifugal System Control module, System 9000. The device is indicated for use in cardiopulmonary bypass procedures only.
The recall was initiated after Terumo CVS received one report of loss of power to the control module and subsequently the drive motor during a cardiopulmonary bypass procedure. The affected units are identified by catalog number 6381 and specific serial numbers listed in the agency documentation.
The product was distributed nationwide in the United States and in numerous countries worldwide, including Canada, Germany, Japan, and Brazil. Users should contact Terumo CVS for instructions on how to proceed with the recall.
The recalled product
- Product
- Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 126
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 (10)
- Catalog number: 6381 and serial numbers: 1003-1006
- 1020
- 1026
- 1045
- 2001
- 2017
- 2018
- 2036
- 7000-7113
- and 7381.
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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