Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump…
Medical device recall Z-0385-2019. Published in FDA’s Enforcement Report on Nov 14, 2018.
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 14, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 118,254,342 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?
Complaints where users were unable to prime the administration set.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and NONPYROGENIC. 12276678 Rev 00 -VersaSafe Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 2120-0500, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-01104 Rev 00 -SmartSite Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump REF 2420-0500,WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-00952 Rev 01 -Infusion Set Alaris Pump Module/Medley Pump Module REF 24009-0007T, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN, FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion 630-00650 Rev 00 Production Usage: Administration sets allow for the intravenous administration of fluids, medications, nutritional support and transfusion therapy through a needle or catheter inserted into the patient s artery or vein. The sets are comprised with components commonly found on intravascular administration sets and extension sets. The components include an Alaris Pump module silicone segment and fitments, drip chamber, check valve, one or more SmartSite needleless connectors, slide clamp, male luer with spin lock and tubing with different length of tubing.
118,254,342, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
January 2017 to March 2018 (Lot number format YYMMXXXX). For example 17011234 was manufactured in January 2017 Model Codes SKU Description 10011301 AS LVP 20D DEHP YELLOW MICROBORE CV Lot Numbers: 17117241 17117057 17105892 17097208…
Every code shown here, 1,997 characters
January 2017 to March 2018 (Lot number format YYMMXXXX). For example 17011234 was manufactured in January 2017 Model Codes SKU Description 10011301 AS LVP 20D DEHP YELLOW MICROBORE CV Lot Numbers: 17117241 17117057 17105892 17097208 17096913 17096125 17076873 17067589 17056330 17046330 17037328 17026902 17026332 17025729 17025596 17016349 10011462 AS LVP 60D DEHP 4VS CV Lot Numbers: 18025365 17116358 17046689 17046553 17035030 17025599 17017620 17016350 10012144 AS LVP 20D DEHP 3SS CV Lot Numbers: 18037198 18037197 18037116 18037020 18037019 18036874 18036873 18036872 18036871 18036788 18036635 18036636 18036634 18036599 18036600 18036596 18036595 18036436 18036437 18036435 18036340 18036339 18036099 18036098 18035928 18035927 18035926 18035765 18035764 18026962 18026863 18026862 18026837 18026751 18026752 18026640 18026641 18026642 18026579 18026578 18026468 18026467 18025993 18025992 18025964 18025902 18025901 18025828 18025827 18025826 18025790 18025718 18025647 18025490 18025646 18025585 18025583 18025584 18016264 18016265 18016266 18016171 18016102 18016101 18016077 18016076 18016006 18016005 18015972 18015971 18015970 18015162 17127054 17126931 17126932 17126935 17126904 17126919 17126920 17126369 17126368 17126154 17126303 17126188 17126008 17126153 17126007 17125901 17125900 17125870 17125869 17118549 17118525 17118481 17118367 17118366 17118251 17118310 17118190 17117888 17117887 17117807 17117806 17106028 17106008 17106007 17105874 17105873 17105680 17105679 17105438 17105579 17105578 17105437 17105436 17105366 17105311 17105310 17097077 17096987 17096986 17095348 17095347 17095346 17095012 17095011 17095010 17086484 17086483 17086456 17086482 17086430 17086455 17085962 17085961 17085960 17085828 17085827 17085767 17085768 17085646 17085684 17075972 17075971 17075893 17075892 17075908 17075875 17075907 17075874 17075882 17075784 17075842 17075728 17075727 17075726 17075851 17075678 17075590 17075589 17075368 17075367 17075271 17075238 17075239 17075178…
FDA’s list runs to 707,536 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 including Guam International: Canada, Australia, New Zealand, EU, Middel East, South Africa, Okinawa, Saipan, Buenos Aires, Lima, Selangor, Hong Kong, Taiwan, and Budapest
The states and territories these words name
- Guam
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 Apr 20, 2018.
- FDA classified it on Nov 3, 2018.
- FDA’s Enforcement Report published it on Nov 14, 2018.
- FDA terminated it on Feb 10, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CareFusion 303, Inc., of San Diego, CA.
- 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 707,536 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.