FDA recall Z-0107-2019

Product

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.

Distribution

NJ

Key facts

Status

Terminated

Initiation date

2018-09-18

Report date

2018-10-24

Termination date

2020-08-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Medina, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0107-2019