Terumo Cardiovascular Procedure Kit Recalled for Incorrect Customer Notification Label
Terumo is recalling 37 units of Cardiovascular Procedure Kits in California due to an incorrect customer notification label applied to the Tyvek lid.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue is an incorrect label and does not report any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Terumo Cardiovascular Systems Corp is recalling 37 units of the Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE (Catalog Number: 73431). The recall is limited to Lot Number RA-27, which was distributed in California.
The recall was initiated because an incorrect customer notification label was applied to the Tyvek lid of the affected kits. The source text does not report any illnesses, injuries, or deaths associated with this labeling error.
Healthcare providers and consumers who have this specific lot of the product should stop using it and contact Terumo Cardiovascular Systems Corp for instructions on how to return the product.
The recalled product
- Product
- Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 37
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 (1)
- Lot Number: RA-27
Distribution
Distributed in 1 state:
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