Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
FDA Device Recall #Z-0529-2022 - Class I, December 29, 2021
Recall Summary
| Recall Number | Z-0529-2022 |
| Classification | Class I - Serious risk |
| Date Initiated | December 29, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corporation |
| Location | Deerfield, IL |
| Product Type | Devices |
| Quantity | 241,304 units |
Product Description
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
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.
Lot / Code Information
All serial numbers, GTIN 00085412610900.
Other Recalls from Baxter Healthcare Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2551-2026 | Class I | Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Singl... | May 21, 2026 |
| Z-2549-2026 | Class I | Hillrom VOLARA P.CIRCUIT 5KIT (System Single Pa... | May 21, 2026 |
| Z-2548-2026 | Class I | Hillrom VOLARA System P.CIRCUIT KIT (Single Pat... | May 21, 2026 |
| Z-2550-2026 | Class I | Hillrom VOLARA System P.CIRCUIT KIT AC (Single ... | May 21, 2026 |
| Z-2262-2026 | Class II | Brand Name: Exacta Mix Product Name: Vented Mi... | Apr 22, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.