Terumo Recalls Angio-Seal Evolution Vascular Closure Devices
Terumo Medical Corp is recalling 240 Angio-Seal Evolution Vascular Closure Devices because they were released before required validation was completed.
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 3/5 (High).
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 involves a medical device that may not function as intended, posing a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Terumo Medical Corp is recalling 240 units of the Angio-Seal Evolution Vascular Closure Device, Catalog No. C610135. The recall involves two lots of the product, identified by codes 5980075 and 5980077.
The recall was initiated because the products were released for distribution prior to the completion of all required validation and lot acceptance activities. Although the devices are sterile, the company states that products from these lots may not function as intended and therefore should not be used.
The affected devices were distributed to accounts in Alabama, California, Florida, Iowa, Indiana, Michigan, Missouri, North Carolina, New York, South Dakota, Tennessee, and Texas. Healthcare providers and facilities should stop using these devices and contact Terumo Medical Corp for further instructions.
The recalled product
- Product
- Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
- Manufacturer
- Terumo Medical Corp
- Hazard
- Affected units
- 240
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 (2)
- 5980075
- 5980077
Distribution
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