Terumo Advanced Perfusion System 1 Recall for Manual Clarity Issues
Terumo is recalling 1,713 Advanced Perfusion System 1 units because the operator manual lacks clarity and accuracy.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II but involves documentation issues (manual clarity) rather than a direct physical hazard or reported injuries, aligning with the Low severity criteria for documentation issues.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 1,713 units of the Terumo Advanced Perfusion System 1 (APS1) 100/120V AC. The recall was initiated after an evaluation of the APS1 Operator Manual determined that existing instructions lack clarity and accuracy regarding specific items.
The affected devices were distributed nationwide in the United States, including the District of Columbia and all 50 states. The recall also covers distribution in Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Malaysia, Mexico, the Philippines, Singapore, South Korea, Taiwan, Thailand, the United Arab Emirates, and Vietnam. The specific catalog number for the affected units is 801763.
Consumers and healthcare facilities should contact Terumo Cardiovascular Systems Corporation for further instructions on how to proceed with the recall and obtain updated documentation.
The recalled product
- Product
- Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 1,713
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)
- Catalog Number 801763
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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