Z-1478-2018 Class II Terminated
FDA device recall Z-1478-2018 was initiated by Terumo Cardiovascular Systems Corporation on Jan 19, 2018 and is designated Class II. Reason for recall: Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or… The recall status is terminated (terminated Jul 18, 2018). Affected quantity: 7.
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- Jan 19, 2018
- Termination Date
- Jul 18, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7
Product Description
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
Reason for Recall
Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).
Distribution Pattern
Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore.
Code Information
Catalog # - 802018 Serial #: 01662, 01672, 01680, 01681,01682, 01683 , and 01687. UDI: 00886799000687.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1478-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026