Spectrum IQ Infusion System with Dose IQ Safety recall
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Why was Spectrum IQ Infusion System with Dose IQ Safety recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018
- Product
- SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 354 units
- Distribution
- NJ
- Recall date
- October 24, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)