FDAFDA · Food and drugs·Recall number Z-0107-2019
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Published October 24, 2018 · Recall initiated: September 18, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- NJ
- Lot
- UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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