Z-0348-2025 Class II Ongoing
FDA device recall Z-0348-2025 was initiated by Baxter Healthcare Corporation on Oct 2, 2024 and is designated Class II. Reason for recall: The door on the Spectrum IQ Infusion pump may not be able to fully close. The recall status is ongoing. Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 20, 2024
- Initiation Date
- Oct 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Reason for Recall
The door on the Spectrum IQ Infusion pump may not be able to fully close.
Distribution Pattern
GA, ID
Code Information
00085412610900, Serial Numbers: 3796578, 3797382, 3797464, 3797578, 3797728, 3797733, 3798019, 3798200
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0348-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026