Z-2530-2024 Class II Ongoing
FDA device recall Z-2530-2024 was initiated by Baxter Healthcare Corporation on Jun 14, 2024 and is designated Class II. Reason for recall: Improperly performed testing prior to release The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 14, 2024
- Initiation Date
- Jun 14, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Reason for Recall
Improperly performed testing prior to release
Distribution Pattern
US Nationwide distribution in the state of Florida.
Code Information
Product Code: 35700BAX2. Serial Number: 2158913.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2530-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026