Z-0107-2019 Class II Terminated

Recalled by Baxter Healthcare Corporation — Medina, NY

Recall Details

Product Type
Devices
Report Date
October 24, 2018
Initiation Date
September 18, 2018
Termination Date
August 19, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
354 units

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.

Distribution Pattern

NJ

Code Information

UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018