BD SmartSite ‘Y’ Extension Set 2 Needle-Free Valves
Medical device recall Z-2455-2021. Published in FDA’s Enforcement Report on Sep 22, 2021.
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 Sep 22, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 53 states named
- 1,839,594 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?
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BD SmartSite ‘Y’ Extension Set 2 Needle-Free Valves, REF: 20019E7D
1,839,594, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots: 20015114 20015115 20015116 20015117 20015118 20025813 20025814 20025815 20025816 20025817 20025818 20025819 20036187 20036188 20036259 20036260 20036261 20036262 20036327 20036328 20036329 20037133 20046569 20046570 20046615 20046616…
Every code shown here, 1,679 characters
Lots: 20015114 20015115 20015116 20015117 20015118 20025813 20025814 20025815 20025816 20025817 20025818 20025819 20036187 20036188 20036259 20036260 20036261 20036262 20036327 20036328 20036329 20037133 20046569 20046570 20046615 20046616 20046617 20055967 20055968 20055984 20055985 20055986 20055987 20055988 20055989 20056364 20056365 20056366 20056452 20056453 20056565 20056566 20057064 20075232 20075235 20075616 20075617 20075238 20085525 20085526 20085774 20085775 20086097 20086098 20086099 20086100 20086101 20086102 20086427 20086428 20086429 20095126 20095127 20095128 20095129 20095130 20095131 20095146 20097042 20095147 20095148 20095150 20095151 20096880 20096881 20097041 20097043 20097044 20097045 20097046 20097047 20105605 20105606 20105607 20106571 20106572 20106573 20106677 20106678 20115001 20115002 20115003 20115004 20115005 20115006 20115007 20115008 20115009 20115010 20115011 20115012 20116408 20116409 20116410 20116411 20116815 20116961 20116830 20116831 20116832 20117063 20117064 20125036 20125037 20125245 20125246 20125247 20125248 20125249 20125250 20125454 20125455 20125456 20125457 20125518 20125519 20125520 20125589 20125590 20125591 20125628 20125629 20125630 20125631 20125632 20125633 20125634 20125635 20125636 20125637 20125638 21015733 21015734 21015735 21015736 21015876 21015877 21015737 21015878 21015879 21015989 21015990 21015991 21016007 21016025 21016026 21016056 21016057 21016058 21016232 21016391 21016392 21035751 21035752 21035753 21035757 21035758 21035754 21035755 21035756 21035759 21035760 21045887 21045888 21045889 21045890 21045891 21046137 21046139 21046140 21046574 21046581 21046656 21046673 21046672 21046717
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 in the states of FL, PA, NC, OH, SC, IL, RI, MO, NY, TN, AL, VA, PR, CA, NE, NJ, MI, MD, NM, LA, KY, NV, ME, OK, WA, MA, WV, TX, AR, OR, KS, GA, VT, IN, WY, AZ, CO, MN, WI, UT, SD, MS, ID, MT, ND, HI, IA, DC, AK, NH, CT, DE, GU and the countries of CA, NZ, TW, AU, BE, VN, AR, MY, TH, KR, ID, PH, SG, BH, SA, HK, IN, CN, BR.
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
- 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
- Utah
- 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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Aug 2, 2021.
- FDA classified it on Sep 13, 2021.
- FDA’s Enforcement Report published it on Sep 22, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CAREFUSION, 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.”
- 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
-
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.