Symbiq One Channel Infuser
Medical device recall Z-0305-2017. Published in FDA’s Enforcement Report on Nov 2, 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 2, 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
- 35,596 devices 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?
Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the “NEXT” button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury.
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 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.
35,596 devices in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
14339017 14339062 14339063 14339066 14339071 14339072 14339076 14339078 14339079 14339084 14339086 14339087 14339089 14339090 14339091 14339095 14339097 14339098 14339099 14339102 14339104 14339105 14339107 14339108 14339111 14339113…
Every code shown here, 1,998 characters
14339017 14339062 14339063 14339066 14339071 14339072 14339076 14339078 14339079 14339084 14339086 14339087 14339089 14339090 14339091 14339095 14339097 14339098 14339099 14339102 14339104 14339105 14339107 14339108 14339111 14339113 14339114 14339115 14339116 14339119 14339121 14339125 14339128 14339130 14339133 14339136 14339138 14339139 14339140 14339141 14339142 14339145 14339146 14339149 14339150 14339152 14339154 14339155 14339158 14339168 14339171 14339172 14339179 14339180 14339185 14339190 14339192 14339194 14339195 14339200 14339201 14339205 14339216 14339228 14339230 14339231 14339233 14339236 14339243 14339246 14339248 14339250 14339251 14339254 14339262 14339271 14339274 14339280 14339283 14339287 14339291 14339293 14339299 14339302 14339304 14339308 14339322 14339327 14339328 14339344 14339346 14339348 14339349 14339351 14339358 14339359 14339361 14339362 14339367 14339369 14339370 14339371 14339372 14339373 14339377 14339378 14339380 14339384 14339388 14339389 14339391 14339392 14339394 14339395 14339396 14339399 14339401 14339407 14339408 14339409 14339410 14339411 14339413 14339414 14339415 14339422 14339423 14339424 14339426 14339504 14339517 14339519 14339522 14339524 14339529 14339534 14339538 14339540 14339545 14339546 14339551 14339552 14339553 14339557 14339569 14339572 14339584 14339652 14339659 14339662 14339664 14339669 14339680 14339681 14339692 14339696 14339705 14339707 14339710 14339712 14339718 14339719 14339723 14339725 14339727 14339733 14339738 14339745 14339748 14339761 14339762 14339763 14339769 14339771 14339774 14339776 14339779 14339787 14339789 14339815 14339823 14339841 14339849 14339866 14339867 14339874 14339876 14339884 14339915 14339921 14339932 14339933 14339935 14339937 14339938 14339945 14339950 14339951 14339952 14339955 14339957 14339960 14339963 14339967 14339969 14339979 14339981 14339983 14339985 14339986 14339987 14339989 14339990 14339991 14339992 14339993 14339996 14339997 14339998 14339999 14340000 14340002…
FDA’s list runs to 199,853 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) 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 Feb 4, 2013.
- FDA classified it on Oct 24, 2016.
- FDA’s Enforcement Report published it on Nov 2, 2016.
- FDA terminated it on Dec 15, 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 199,853 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.