Terumo Cardiovascular Procedure Kits Recalled for Incorrect Tubing Coating Labeling
Terumo is recalling 2,207 cardiovascular procedure kits because they are labeled as containing coated tubing but actually contain non-coated tubing.
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 the issue is a labeling discrepancy regarding the tubing coating. No illnesses, injuries, or deaths are reported in the source text, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Terumo Cardiovascular Systems Corp is recalling 2,207 units of Terumo Custom Cardiovascular Procedure Kits. The recall was initiated because the kits are labeled as containing Xcoating surface coated tubing, but the tubing inside is actually non-coated.
These kits are intended for use in the extracorporeal circuit for cardiopulmonary bypass procedures. The affected products were distributed nationwide and to foreign locations including Canada and Latin America. The recall involves specific US and OUS lot codes, including UG06, UE18R, UF31, and others.
Healthcare facilities and users should stop using the affected kits and contact Terumo Cardiovascular Systems Corp for instructions on how to return or dispose of the products.
The recalled product
- Product
- Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a…
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Hazard
- Affected units
- 2,207
Distribution
Distributed nationwide across the United States.
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