Terumo Tubing Pack Convenience Kit Recalled for Incorrect Expiration Date
Terumo is recalling Tubing Pack Convenience Kits labeled with an incorrect expiration date of April 30, 2019.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 and involves a minor labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Terumo Cardiovascular Systems Corp is recalling Tubing Pack Convenience Kits, Product Code 65217. The affected units were labeled with an incorrect expiration date of April 30, 2019.
The recall involves 30 cases containing 2 units each, for a total of 60 units. These products were distributed to the US state of Florida. The kits are intended for use only in the extracorporeal circuit of cardiopulmonary bypass procedures.
Users should stop using the affected kits and contact Terumo Cardiovascular Systems Corp for further instructions.
The recalled product
- Product
- Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Hazard
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: VE17
Distribution
Distributed in 1 state:
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