Z-0530-2022 Class I Ongoing
FDA device recall Z-0530-2022 was initiated by Baxter Healthcare Corporation on Dec 29, 2021 and is designated Class I. Reason for recall: There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or… The recall status is ongoing. Affected quantity: 146,502 units.
Recall details
- Product Type
- Devices
- Report Date
- Feb 9, 2022
- Initiation Date
- Dec 29, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 146,502 units
Product description
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
Reason for recall
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.
Distribution pattern
Worldwide Distribution. US nationwide Puerto Rico and St. Thomas. There was government/military distribution. Countries of Canada, Bahamas, Barbados, Bermuda, Guyana, Jamaica, and Trinidad and Tobago.
Code information
All serial numbers, GTIN 00085412498683.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0530-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026