Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter…
Medical device recall Z-1663-2018. Published in FDA’s Enforcement Report on May 16, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 16, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 444 units in total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 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 includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The 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.
444 units in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers 400792 402108 718349 719336 720207 724491 724820 725718 725967 728874 728899 732513 734021 734895 736505 737537 743970 745479 745645 746786 746958 749627 753240 755355 755385 757870 759563 762135 763024 765577 766622 769032…
Every code shown here, 1,658 characters
Serial Numbers 400792 402108 718349 719336 720207 724491 724820 725718 725967 728874 728899 732513 734021 734895 736505 737537 743970 745479 745645 746786 746958 749627 753240 755355 755385 757870 759563 762135 763024 765577 766622 769032 769488 778233 782558 786281 786340 786870 787341 792737 795834 796263 800153 800502 801288 802530 805121 805471 805801 806919 807211 813520 814347 814382 815314 816930 820150 820359 822492 825071 825229 825451 826055 826627 828591 828705 829397 830727 831128 831212 831302 831547 831565 832787 833304 834044 834712 835095 835382 835391 836112 836152 837841 838434 838774 839173 840083 840954 842022 842183 845112 845156 847861 847901 848231 848841 849061 849254 849944 850141 850340 851569 852394 852641 852892 853302 853382 853786 854089 855099 855122 855273 856674 856866 859951 860191 860303 862042 863777 865269 865418 865580 865720 866428 867262 868826 869057 869182 869234 869974 871376 871764 871877 872071 872863 873254 873259 874491 878338 879016 880653 880795 880832 880843 880964 881244 881617 881705 881777 881918 882789 883187 883398 883416 883633 884068 884237 886454 887689 889858 890428 890758 894234 894348 894617 895900 898761 901813 904457 905119 906737 907869 908249 909244 912418 912732 915132 915423 916017 919364 920356 925142 927197 928329 929730 930711 936707 938183 939798 940023 940386 940611 942273 943001 943885 943973 944249 946995 953811 954927 957053 959168 959347 960426 962828 963374 963861 964644 965116 973423 974215 977054 977058 978363 982851 988268 989495 990271 990388 991778 992782 993040 993151 993935 994571 994836 995376 998593 1000562 1000614 1000881 1001843 1002586 1013602
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide & Puerto Rico
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 3, 2018.
- FDA classified it on May 4, 2018.
- FDA’s Enforcement Report published it on May 16, 2018.
- FDA terminated it on Feb 14, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Baxter Healthcare Corporation, of Medina, NY.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.