Terumo Advanced Perfusion System 1 Gas System Recall
Terumo is recalling 648 Advanced Perfusion System 1 units because users reported difficulty adjusting the gas system flow control knob.
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 the source text describes a usability issue (difficulty adjusting a knob) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 648 units of the Terumo Advanced Perfusion System 1 Base, 100/120V. The recall was initiated after the company received two complaints from users who experienced difficulty adjusting the System 1 Gas System local flow control knob.
The affected devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. The electronic gas blender controls and monitors gas flow rates and oxygen content. The recall covers units with catalog number 801763 and specific serial numbers ranging from 0011-0335 to 1447-1450.
The devices were distributed nationwide in the United States and in numerous countries worldwide, including Argentina, Belgium, Canada, and Germany. Users should contact Terumo Cardiovascular Systems Corporation for further instructions on how to address the issue with the flow control knob.
The recalled product
- Product
- Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 648
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 (8)
- catalog number: 801763 and Serial numbers: 0011-0335
- 0337-0610
- 1001-1034
- 1037-1049
- 1100
- 1103-1106
- 1109-1445
- and 1447-1450.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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