CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI 00886799001889 Lot Number/Serial Number Range: B0050231-B0050240 B0050221-B0050230 B0050211-B0050219 B0050201-B0050209 B0050191-B0050200
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Terumo Cardiovascular Systems Corporation
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Product Codes/Lot Numbers:
UDI-DI 00886799001889 Lot Number/Serial Number Range: B0050231-B0050240 B0050221-B0050230 B0050211-B0050219 B0050201-B0050209 B0050191-B0050200
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2018-2025
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