Symbiq Two Channel Infuser
Medical device recall Z-0362-2017. 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
- 10897 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 Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. 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.
10897, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
14589022 14589046 14589066 14589083 14589108 14589117 14589154 14589165 14589169 14589172 14589232 14589235 14589264 14589276 14589277 14589293 14589321 14589328 14589346 14589382 14589399 14589431 14589451 14589587 14589642 14589692…
Every code shown here, 1,998 characters
14589022 14589046 14589066 14589083 14589108 14589117 14589154 14589165 14589169 14589172 14589232 14589235 14589264 14589276 14589277 14589293 14589321 14589328 14589346 14589382 14589399 14589431 14589451 14589587 14589642 14589692 14589696 14589720 14589721 14589733 14589761 14589779 14589792 14589802 14590003 14590023 14590035 14590117 14590153 14590279 14590287 14590315 14590324 14590409 14590436 14590445 14590469 14590484 14590507 14590526 14590527 14590531 14590542 14590544 14590548 14590568 14590582 14590677 14590687 14590693 14590736 14590796 14590830 14590877 14590905 14590947 14590956 14591038 14591080 14591081 14591182 14591210 14591386 14591406 14591442 14591460 14591473 14591496 14591500 14591518 14591574 14591583 14591599 14591632 14591634 14591672 14591673 14591678 14591696 14591697 14591723 14591741 14591760 14591761 14591762 14591773 14591783 14591815 14591819 14591820 14591828 14591841 14591861 14591870 14591876 14591879 14591880 14591886 14591887 14591899 14591906 14591914 14591928 14591930 14591950 14591972 14591995 14591997 14592016 14592034 14592041 14592065 14592067 14592068 14592069 14592075 14592090 14592095 14592112 14592116 14592122 14592125 14592143 14592162 14592222 14592226 14592242 14592248 14592271 14592342 14592351 14592358 14592402 14592441 14592453 14592462 14592499 14592503 14592530 14592539 14592614 14592621 14592635 14592644 14592655 14592689 14592756 14592761 14592785 14592787 14592806 14592810 14592860 14592863 14592878 14592892 14592897 14592909 14592937 14592945 14592946 14592962 14592964 14592974 14592993 14593010 14593022 14593056 14593065 14593080 14593107 14593122 14593131 14593147 14593161 14593165 14593219 14593235 14593244 14593255 14593296 14593314 14593339 14593353 14593372 14593398 14593428 14593448 14593456 14593488 14593531 14593554 14593561 14593643 14593658 14593666 14593668 14593702 14593749 14593797 14593843 14593891 14593907 14593911 14594057 14594108 14594147 14594159 14594162 14594171 14594315 14594335…
FDA’s list runs to 68,111 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 68,111 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.