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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Baxter Healthcare Corporation
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1248-2019
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