Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX -...
FDA Device Recall #Z-1248-2019 — Class II — June 21, 2018
Recall Summary
| Recall Number | Z-1248-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 21, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corporation |
| Location | Medina, NY |
| Product Type | Devices |
| Quantity | 158 |
Product Description
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - 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 physician s directive.
Reason for Recall
The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time. Improperly performed flow rate testing may not identify issues with pumps that could cause inaccuracies in flow rates which, in turn, could lead to over- or under- infusion. Potential risk to the patient depends on a number of factors including treatment and patient comorbidities. Depending on these factors, the patient could experience serious adverse health consequences.
Distribution Pattern
US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, FA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, VT, WA, and WI.
Lot / Code Information
414100 414670 433162 710740 717215 719988 720854 721951 722543 722933 725642 732556 734067 749265 749642 749657 751266 754953 755565 756625 756644 758179 759427 760110 760525 761003 762192 763831 764008 772521 772551 772633 776752 777472 777487 777680 777749 778181 778251 778579 779966 780547 780718 780817 782396 782707 782811 783349 783493 786411 788383 788710 789338 789840 790679 792271 792369 794031 794748 799042 800030 801760 801943 803923 804476 804682 806531 813188 814142 816514 820804 821669 823024 823027 824627 824732 825824 826787 829610 831764 832868 834783 835743 836236 837842 839622 840360 840428 841012 841184 841214 841342 842898 843667 843683 847890 848208 848231 848488 848787 849440 849507 849907 850267 850852 851179 851268 852222 853708 854814 855334 855504 855857 856876 856969 858560 860351 861014 861464 861482 863379 868085 870747 871288 874631 875102 875155 878163 878164 881784 884140 892778 894505 899196 909742 910678 918775 921328 923433 937769 942978 944660 945944 949235 953654 954700 954902 963058 970869 974360 976700 977543 981313 983629 984364 988111 988760 995070
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.