Alaris Pump Infusion Set
Medical device recall Z-1770-2019. Published in FDA’s Enforcement Report on Jul 17, 2019.
- FDA Class I
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 Jul 17, 2019. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 53 states named
- 17992 lots of Infusion Sets totaling 183,572,651 units (Updated 8/26/19) 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-0500, 2421-0500, 2426-0007, 2426-0500, 2429-0500, 2433-0007, 2477-0000, 2477-0007 2478-0000 C24116E Infusion 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.
17992 lots of Infusion Sets totaling 183,572,651 units (Updated 8/26/19), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Numbers UDI: 07613203021135- 18096166 18096167 18096235 18096236 18096294 18096295 18096301 19026173 UDI: 07613203015806- 17087410 17087411 18096003 UDI: 07613203021159- 18096803 18096804 UDI: 10885403223204- 18095427 18095428 UDI:…
Every code shown here, 1,992 characters
Lot Numbers UDI: 07613203021135- 18096166 18096167 18096235 18096236 18096294 18096295 18096301 19026173 UDI: 07613203015806- 17087410 17087411 18096003 UDI: 07613203021159- 18096803 18096804 UDI: 10885403223204- 18095427 18095428 UDI: 10885403227981- 18096296 18096293 18096273 18096272 18096229 18096228 UDI: 10885403233999- 17087192 17087329 17087330 17087331 18036906 18036907 UDI: 07613203019088- 18116304 UDI: 07613203021234- 18096302 18096422 UDI: 07613203021197- 19025787 UDI: 10885403232305- 18096500 18096501 18096611 UDI: 10885403228001- 18015347 18076591 18076660 UDI: 07613203012713- 17087446 UDI: 07613203012638- 18095286 18095287 18095355 UDI: 07613203012638- 17087336 17087337 17087412 UDI: 10885403226090- 18096312 18096313 18096358 (updated 8/26/19) UDI: 10885403227950- 18096609 18096610 UDI: 07613203021012- 17077279 17077398 17113133 17113134 17118801 17118810 18015266 18015267 18015351 18015353 18015458 18015459 18015568 18026598 18026601 18036759 18036760 18036761 18036941 18036965 18036966 18036967 18037062 18037063 18037064 18075677 18075700 18075709 18075714 18075715 18075716 18076779 18076784 18076830 18086266 18086339 18093065 18093066 18093070 UDI: 07613203021012- 18093076 18093077 18095339 18095354 18095359 18095360 18095412 18095889 18095980 18095991 18095996 18096179 18096180 18115088 18115135 18116622 18116623 18116624 18116707 19013154 19013155 19023000 19026122 19026123 19026211 19033033 UDI: 07613203012430- 17077358 17113141 17113142 17113146 18023014 18076737 18076738 18076739 18076740 18076741 18086332 18086333 18086334 18093055 18093056 18093057 18093072 18093073 18093074 18093075 18095068 18095357 18095358 18095417 18116640 18116641 18116703 19026180 19026215 19026262 UDI: 07613203019149- 18096445 UDI: 10885403227998- 17077131 17077313 17087341 17125017 18015417 18015453 18015454 18026723 18026724 18026754 18036897 18075724 18076609 18076610 18076611 18086142 18086230 18086259 18086330 18095280 18115006 18115007 18115132 18116575…
FDA’s list runs to 4,805 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 distribution) to following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, ID, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY, and Puerto Rico; and countries of: Australia, Belgium, Canada, Chile, Malaysia, Mexico, Panama, Singapore and Taiwan.
The states and territories these words name
53 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Guam
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Northern Mariana Islands
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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 May 6, 2019.
- FDA classified it on Jul 11, 2019.
- FDA’s Enforcement Report published it on Jul 17, 2019.
- FDA terminated it on Jul 19, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Becton Dickinson & Company, of Franklin Lakes, NJ.
- 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 4,805 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.