Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX...
FDA Device Recall #Z-2113-2018 — Class II — May 8, 2018
Recall Summary
| Recall Number | Z-2113-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 8, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corporation |
| Location | Medina, NY |
| Product Type | Devices |
| Quantity | 122889 |
Product Description
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physicians directive.
Reason for Recall
The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a secondary infusion. However, the firm supplies 12.5-inch hangers with the Baxter disposable secondary sets.
Distribution Pattern
Worldwide Distribution - US Nationwide and the country of Canada.
Lot / Code Information
All serial numbers manufactured from7/1/2014 and forward, with release dates 7/1/2014 and forward.
Other Recalls from Baxter Healthcare Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1573-2026 | Class II | Brand Name: Welch Allyn, Inc. Product Name: We... | Feb 18, 2026 |
| Z-1368-2026 | Class II | Brand Name: Spectrum IQ Product Name: Infusion... | Jan 13, 2026 |
| Z-1121-2026 | Class II | SIGMA Spectrum Infusion Pump, Model/Catalog Num... | Nov 28, 2025 |
| Z-0847-2026 | Class II | Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalo... | Oct 28, 2025 |
| Z-0233-2026 | Class II | Oral Probe (Product code 02893-000), accessory ... | Sep 17, 2025 |
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.