Terumo Flowmeter Module Recalled for Inaccurate Flow Readings
Terumo Cardiovascular Systems Corporation is recalling seven Flowmeter Modules for the Advanced Perfusion System 1 due to inaccurate flow readings that may be difficult to detect.
What this means for you
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 is classified as FDA Class II. The hazard involves inaccurate flow readings in a medical device, which poses a risk of harm if undetected, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling seven Flowmeter Modules, which are accessories to the Terumo Advanced Perfusion System 1. These modules provide the interface between the flow sensor and the system. The recall is due to inaccurate flow readings.
Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use, particularly following a Flow Probe relocation or manipulation. The affected units were distributed worldwide, including in the United States (Illinois, Kentucky, and Michigan) and Singapore.
The affected units are identified by Catalog # 802018 and Serial #s 01662, 01672, 01680, 01681, 01682, 01683, and 01687. The UDI is 00886799000687. Users should contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 7
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 (7)
- Catalog # - 802018 Serial #: 01662
- 01672
- 01680
- 01681
- 01682
- 01683
- and 01687. UDI: 00886799000687.
Distribution
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