Recall Z-0107-2019— Baxter Healthcare Corporation
Class II · Terminated
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2018-09-18, terminated 2020-08-19. It names one FDA 510(k) clearance: K173084. Product: SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009. 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
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-18
- Terminated
- 2020-08-19
- Firm location
- Medina, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.