Symbiq Two Channel Infuser
Medical device recall Z-0354-2017. Published in FDA’s Enforcement Report on Nov 9, 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 9, 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
- 15,285 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?
Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September 2012. On pumps where incorrect installation of components has occurred, the backup battery power discharges and subsequently, the battery cannot be charged. Because of the battery depletion, or lack of charge, a visual and audible warning alarm, S205, is displayed. An S205 alarm is intended to notify the customer that the coin call battery, powering the backup buzzer, may need to be charged or replaced.
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; Product List Number 16027
15,285, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 14589003 14589008 14589009 14589012 14589013 14589014 14589015 14589017 14589020 14589022 14589028 14589030 14589031 14589033 14589034 14589035 14589043 14589046 14589048 14589049 14589050 14589053 14589057 14589060…
Every code shown here, 1,996 characters
Serial Numbers: 14589003 14589008 14589009 14589012 14589013 14589014 14589015 14589017 14589020 14589022 14589028 14589030 14589031 14589033 14589034 14589035 14589043 14589046 14589048 14589049 14589050 14589053 14589057 14589060 14589063 14589064 14589066 14589068 14589072 14589078 14589082 14589083 14589086 14589092 14589095 14589100 14589101 14589105 14589108 14589110 14589111 14589116 14589117 14589118 14589121 14589127 14589131 14589133 14589135 14589136 14589137 14589139 14589140 14589141 14589144 14589148 14589149 14589151 14589154 14589159 14589160 14589161 14589162 14589165 14589167 14589169 14589172 14589174 14589175 14589178 14589180 14589188 14589195 14589203 14589204 14589206 14589214 14589215 14589221 14589222 14589225 14589228 14589230 14589231 14589232 14589233 14589235 14589237 14589241 14589245 14589248 14589252 14589257 14589258 14589259 14589260 14589264 14589265 14589267 14589270 14589272 14589273 14589275 14589276 14589277 14589278 14589279 14589282 14589283 14589285 14589292 14589293 14589294 14589296 14589298 14589302 14589303 14589304 14589317 14589320 14589321 14589323 14589327 14589328 14589331 14589339 14589346 14589350 14589351 14589353 14589355 14589356 14589360 14589361 14589377 14589379 14589382 14589386 14589387 14589388 14589390 14589392 14589394 14589395 14589397 14589398 14589399 14589404 14589406 14589413 14589414 14589418 14589420 14589425 14589428 14589429 14589431 14589438 14589447 14589448 14589451 14589454 14589455 14589461 14589462 14589465 14589467 14589580 14589587 14589589 14589590 14589594 14589598 14589599 14589600 14589604 14589605 14589617 14589621 14589624 14589625 14589626 14589627 14589630 14589632 14589633 14589642 14589643 14589645 14589650 14589651 14589652 14589653 14589654 14589660 14589661 14589668 14589669 14589670 14589677 14589678 14589680 14589682 14589683 14589692 14589694 14589696 14589700 14589702 14589710 14589716 14589720 14589721 14589723 14589724 14589725 14589726 14589731 14589733 14589738…
FDA’s list runs to 149,610 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.
Nationwide Distribution 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.
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 5, 2013.
- FDA classified it on Nov 3, 2016.
- FDA’s Enforcement Report published it on Nov 9, 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 149,610 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.