Z-0107-2019 Class II Terminated
FDA device recall Z-0107-2019 was initiated by Baxter Healthcare Corporation on Sep 18, 2018 and is designated Class II. 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… The recall status is terminated (terminated Aug 19, 2020). Affected quantity: 354 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 24, 2018
- Initiation Date
- Sep 18, 2018
- Termination Date
- Aug 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0107-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026