Terumo Sarns Centrifugal System Battery Backup Recall for Malfunctions
Terumo CVS is recalling Sarns Centrifugal System batteries due to reports of charging and operational failures that could cause loss of arterial flow.
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 recall is classified as FDA Class II and involves a medical device used in cardiopulmonary bypass where malfunction could result in an unexpected loss of arterial flow, posing a significant risk of serious injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the 100/115V battery backup system, including the charger and connecting cable, for the Sarns Centrifugal System. The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
The recall is being issued due to multiple reports received since 2004 regarding various malfunctions of the battery backup system. These reports are categorized as failure to charge, failure to hold charge, and failure to operate. In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow.
The affected units were distributed worldwide, including in the United States, Puerto Rico, and numerous international locations. The recall involves catalog number 9490 and specific lot numbers ranging from 0101 to 3063. Users should contact Terumo Cardiovascular Systems Corporation for instructions on how to proceed with the recall.
The recalled product
- Product
- Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 1,076
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 (12)
- Catalog number: 9490
- and lot numbers: 0101
- 1001-1025
- 1188-1192
- 1997
- 2000-2017
- 2019- 2082
- 2086-2287
- 2290-2446
- 2452-2633
- 2636-2938
- and 2946-3063
Distribution
Part of a larger recall action
This product is one of 2 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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Same hazard · loss of arterial flow
See all →- SevereTerumo Sarns Centrifugal System Battery Backup Recall
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