Z-0107-2019 Class II Terminated
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