Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library
Medical device recall Z-1490-2012. Published in FDA’s Enforcement Report on Jun 20, 2012.
- FDA Class I
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 Jun 20, 2012. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 63,225 pumps total (corrected number): Domestic - 63,032 pumps; Canada - 29 pumps; Okinawa - 164 pumps 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion. Sigma’s evaluation of subsequent complaints involving failed bearings indicated that the loss or degradation of bearing lubricant to be a more significant contributor to bearing failure than initially believed. Based upon the results of the analysis of these additional failures, Sigma determined that any bearings prior to the latest, improved design may be at risk for failure. Sigma decided to expand the recall of the Spectrum Infusion Pumps to include units manufactured from 1/18/2005 through 11/01/2010.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous fluids. These fluids may include blood, blood products or mixtures of pharmaceutical drugs for required patient therapy. The Spectrum is used in conjunction with legally marked intravenous administration sets and medications provided by the user. The Master Drug Library is a software package that will add additional features to the Spectrum Infusion Pump. The Master Drug Library will permit electronic communications with the Spectrum pump and other external peripheral devices. The intended use of the Spectrum pump includes common drug error prevention, through the stand alone settings features of the pump. This includes drug parameter limits and associated drug name identification. With the Master Drug Library, the intended use is to reduce user errors associated with drug selection, drug dose rates, drug dose concentrations, and patient identification associated with the prescribed drug.
63,225 pumps total (corrected number): Domestic - 63,032 pumps; Canada - 29 pumps; Okinawa - 164 pumps, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers ranging from 700000 through 794213: 700000, 700001, 700002, 700003, 700004, 700005, 700006, 700007, 700010, 700012, 700013, 700014, 700017, 700018, 700020, 700021, 700022, 700023, 700024, 700029, 700030, 700031, 700032,…
Every code shown here, 1,995 characters
Serial numbers ranging from 700000 through 794213: 700000, 700001, 700002, 700003, 700004, 700005, 700006, 700007, 700010, 700012, 700013, 700014, 700017, 700018, 700020, 700021, 700022, 700023, 700024, 700029, 700030, 700031, 700032, 700033, 700034, 700035, 700037, 700038, 700039, 700040, 700041, 700042, 700043, 700045, 700046, 700047, 700048, 700049, 700050, 700051, 700052, 700053, 700054, 700055, 700057, 700058, 700059, 700060, 700061, 700062, 700063, 700064, 700065, 700066, 700067, 700069, 700071, 700073, 700075, 700076, 700077, 700080, 700081, 700082, 700085, 700086, 700088, 700089, 700090, 700093, 700094, 700095, 700097, 700098, 700100, 700101, 700103, 700104, 700106, 700108, 700109, 700110, 700111, 700112, 700114, 700117, 700118, 700119, 700120, 700121, 700123, 700126, 700127, 700129, 700130, 700132, 700133, 700134, 700135, 700137, 700138, 700139, 700141, 700142, 700143, 700144, 700145, 700147, 700149, 700151, 700152, 700153, 700156, 700157, 700158, 700159, 700161, 700162, 700163, 700165, 700166, 700168, 700169, 700170, 700172, 700173, 700174, 700175, 700176, 700177, 700178, 700179, 700180, 700183, 700184, 700187, 700189, 700193, 700194, 700195, 700197, 700201, 700202, 700203, 700204, 700205, 700206, 700207, 700208, 700209, 700210, 700211, 700212, 700213, 700214, 700215, 700216, 700217, 700218, 700219, 700220, 700222, 700223, 700224, 700225, 700226, 700229, 700231, 700232, 700233, 700234, 700235, 700236, 700237, 700238, 700239, 700240, 700241, 700242, 700243, 700244, 700245, 700246, 700248, 700249, 700250, 700251, 700252, 700253, 700255, 700256, 700257, 700258, 700259, 700260, 700263, 700265, 700267, 700268, 700269, 700271, 700272, 700273, 700274, 700275, 700277, 700278, 700280, 700282, 700283, 700284, 700285, 700286, 700287, 700288, 700289, 700292, 700293, 700294, 700295, 700297, 700298, 700299, 700301, 700302, 700303, 700305, 700306, 700307, 700308, 700309, 700310, 700311, 700312, 700314, 700316, 700317, 700318, 700319, 700320, 700321, 700322, 700323,…
FDA’s list runs to 505,415 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 - USA Nationwide including Puerto Rico and the countries of Canada and Okinawa
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.
The words say it went outside the United States too.
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 Jul 6, 2011.
- FDA classified it on Jun 13, 2012.
- FDA’s Enforcement Report published it on Jun 20, 2012.
- FDA terminated it on Oct 17, 2017.
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.”
- FDA’s list of codes runs to 505,415 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
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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.