Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570)
Medical device recall Z-0971-2018. Published in FDA’s Enforcement Report on Mar 21, 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 Mar 21, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 2 states named in where it went
- 173,375 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?
Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.
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) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
173,375, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
700000 700001 700008 400012 700014 700015 700038 400040 400044 400057 700060 400068 700070 400073 400076 700078 700079 400085 700088 700099 700105 400106 400114 700117 700131 700137 400141 700148 700180 700194 700197 400226 700227 700228…
Every code shown here, 1,995 characters
700000 700001 700008 400012 700014 700015 700038 400040 400044 400057 700060 400068 700070 400073 400076 700078 700079 400085 700088 700099 700105 400106 400114 700117 700131 700137 400141 700148 700180 700194 700197 400226 700227 700228 700229 700232 700236 700239 400245 700252 700254 700260 700262 700274 400282 700291 700300 700305 700306 400311 700313 700336 700347 700351 700352 400355 700356 700358 400368 700374 700376 700379 400382 700398 700400 700412 700434 700447 700465 700467 700470 400474 400480 700482 700495 700500 700517 700521 700526 700535 700544 700548 700555 700574 700585 400592 700610 400620 400621 400634 700668 700670 700671 700680 400682 700689 700691 400747 400748 400752 700757 400761 700762 700778 700802 700814 700820 400828 400844 700850 700863 700872 700883 700887 700888 700895 700901 700906 700929 700940 400948 400984 701013 401017 701021 401028 701041 401082 701084 401091 701123 701136 701176 401177 401186 401209 701210 401220 701221 701224 701232 701277 701312 401313 701327 401341 701358 701362 701382 701451 701455 701458 701459 701463 701466 701469 701474 701476 701478 701489 701490 701497 701498 701500 701503 701509 701512 701521 701522 701523 701526 701544 401666 401677 701710 701736 401751 701772 701778 701816 701821 401830 701833 401844 401849 401850 401851 401856 701857 401860 701864 701868 401874 701877 401889 401891 701894 401903 401907 401931 701935 401938 701944 401946 401957 701960 401970 401978 701984 701990 701991 702000 702002 702003 702005 702017 702018 702020 702021 702022 702030 702032 702033 702037 702042 702043 702044 702046 702049 702051 702063 702064 702066 702071 702073 702077 402097 702103 402108 702112 702114 402116 702129 702130 702145 702149 702179 402196 402203 702263 702322 702354 702386 702444 702447 702473 702474 702483 702503 702506 702538 702549 702592 402601 702624 702649 702669 702673 702677 702679 702692 702701 702703 702705 702728 702729 402761 702784 702785 702787 702789 702799 702802 702804 702805…
FDA’s list runs to 2,347,487 characters. The first part is shown; the rest is on FDA’s record.
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.
Worldwide Distribution - US, including the District of Columbia, Puerto Rico, and Canada.
The states and territories these words name
- District of Columbia
- Puerto Rico
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Oct 6, 2017.
- FDA classified it on Mar 12, 2018.
- FDA’s Enforcement Report published it on Mar 21, 2018.
- FDA terminated it on Apr 11, 2019.
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: E-Mail.
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.”
- FDA’s list of codes runs to 2,347,487 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.