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 in specific instructions.
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 and involves a documentation issue (manual clarity) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 1,713 units of the Terumo Advanced Perfusion System 1 220/240V AC (Advanced Perfusion System Platform). The recall was initiated after an evaluation of the APS1 Operator Manual determined that existing instructions lack clarity and accuracy related to 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.
Healthcare providers and consumers should contact Terumo Cardiovascular Systems Corporation for further instructions regarding the replacement or correction of the operator manual. The recall number is Z-2019-2014.
The recalled product
- Product
- Terumo¿ Advanced Perfusion System 1 220/240V 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 801764
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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