CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CD...
FDA Recall #Z-2018-2025 — Class II — May 28, 2025
Product Description
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Reason for Recall
Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.
Recalling Firm
Terumo Cardiovascular Systems Corporation — Ann Arbor, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
28 US; 7 OUS
Distribution
US Nationwide distribution in the states of California, Delaware, Hawaii, Iowa, Indiana, Michigan, North Carolina, New York, Ohio, and Washington. The country of New Zealand.
Code Information
UDI-DI 00886799001889 Lot Number/Serial Number Range: B0050231-B0050240 B0050221-B0050230 B0050211-B0050219 B0050201-B0050209 B0050191-B0050200
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated