Terumo HX2 Temperature Management System Recall for Updated Cleaning Instructions
Terumo is recalling HX2 Temperature Management Systems to update cooler-heater cleaning instructions. The recall affects 2,393 units distributed worldwide.
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, but the source text explicitly states the reason is an update to cleaning instructions without reporting any injuries, illnesses, or specific safety hazards. This aligns with the rubric for moderate severity involving minor labeling or documentation issues.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the Terumo HX2 Temperature Management System, Catalog No. 809810. This device is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery. The recall involves 2,393 units in total.
The reason for the recall is an update to the cooler-heater cleaning instructions. The source text does not specify any reported injuries, illnesses, or specific defects beyond the need for updated instructions.
The affected products were distributed worldwide, including the United States (Nationwide), Australia, Belgium, Canada, Chile, China, Colombia, Dominican Republic, England, Finland, France, Germany, Greece, HK, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and Vietnam. All lot codes are affected. Users should refer to the updated cleaning instructions provided by the manufacturer.
The recalled product
- Product
- Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 2,393
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)
- All Lot Codes
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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