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
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (cardiopulmonary bypass equipment) where a functional failure (power loss) was reported, but no specific injuries or illnesses are documented in the source text.
Plain-English summary
Terumo Cardiovascular Systems Corporation (Terumo CVS) is recalling the Sarns Centrifugal System Control module, 220/240V. This medical device is indicated for use in cardiopulmonary bypass procedures only. The recall involves 213 units with catalog number 6380 and specific serial numbers ranging from 5007 to 7373.
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 numerous international locations such as Canada, Germany, Japan, and Brazil.
Healthcare facilities and users should stop using the affected Sarns Centrifugal System Control modules immediately. Terumo CVS is the recalling firm responsible for managing this safety action.
The recalled product
- Product
- Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 213
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 (14)
- Catalog number: 6380 and serial numbers: 5007
- 5028-5030
- 5032
- 5075
- 5076
- 5135
- 6010
- 6013
- 6025
- 6030
- 6116
- 7000-7197
- 7372
- and 7373.
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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