Symbiq One Channel Infuser
Medical device recall Z-0361-2017. Published in FDA’s Enforcement Report on Nov 16, 2016.
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 Nov 16, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 10,337 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?
May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes. Delay or interruption of therapy.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
10,337, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
14339017 14339063 14339071 14339076 14339078 14339084 14339086 14339087 14339091 14339095 14339097 14339104 14339105 14339108 14339114 14339115 14339119 14339125 14339130 14339140 14339142 14339145 14339146 14339149 14339158 14339171…
Every code shown here, 1,998 characters
14339017 14339063 14339071 14339076 14339078 14339084 14339086 14339087 14339091 14339095 14339097 14339104 14339105 14339108 14339114 14339115 14339119 14339125 14339130 14339140 14339142 14339145 14339146 14339149 14339158 14339171 14339172 14339192 14339195 14339200 14339271 14339283 14339304 14339308 14339322 14339327 14339328 14339344 14339358 14339359 14339362 14339367 14339369 14339370 14339377 14339380 14339384 14339389 14339391 14339392 14339396 14339407 14339411 14339413 14339414 14339415 14339422 14339424 14339426 14339504 14339517 14339519 14339524 14339529 14339534 14339545 14339569 14339572 14339664 14339669 14339681 14339723 14339789 14339849 14339905 14339921 14339932 14339933 14339985 14339987 14339989 14339990 14340000 14340002 14340004 14340006 14340008 14340017 14340027 14340038 14340039 14340041 14340048 14340053 14340058 14340060 14340063 14340065 14340067 14340071 14340072 14340077 14340078 14340080 14340084 14340088 14340089 14340103 14340105 14340106 14340123 14340125 14340126 14340128 14340138 14340150 14340153 14340167 14340170 14340180 14340186 14340192 14340205 14340214 14340217 14340223 14340232 14340255 14340272 14340273 14340277 14340287 14340377 14340627 14340659 14340709 14340722 14340747 14340760 14340770 14340816 14340845 14340865 14340913 14340935 14341101 14341120 14341141 14341158 14341160 14341246 14341290 14341342 14341363 14341402 14341414 14341461 14341469 14341481 14341502 14341521 14341523 14341553 14341579 14341681 14341727 14341746 14341752 14341763 14341825 14341879 14341889 14341924 14341944 14341969 14341986 14342018 14342129 14342146 14342153 14342161 14342177 14342183 14342197 14342253 14342275 14342322 14342375 14342376 14342384 14342400 14342491 14342493 14342535 14342581 14342619 14342657 14342664 14342668 14342678 14342694 14342752 14342857 14342886 14342907 14342911 14342926 14342939 14342958 14342986 14343051 14343068 14343091 14343149 14343168 14343194 14343254 14343258 14343328 14343331 14343359 14343407…
FDA’s list runs to 100,110 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 (nationwide) and Canada
These words name no state.
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 Mar 16, 2011.
- FDA classified it on Nov 4, 2016.
- FDA’s Enforcement Report published it on Nov 16, 2016.
- FDA terminated it on Nov 28, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Hospira Inc., of Lake Forest, IL.
- 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 100,110 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.