Baxter Healthcare Corporation
Date of Enforcement Report 10/24/2018
Class II:
PRODUCT
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Recall Number: Z-0107-2019
REASON
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.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corporation, Medina, NY on 9/18/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
354 units
DISTRIBUTION
NJ