BD Extension Set SMALLBORE Tubing SmartSite VALVE
Medical device recall Z-2460-2021. 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
- 20,874,700 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 Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10010912; BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE, REF: 10010983; BD Gravity Burette Set 60 DP 4 VersaSafe PORTS 3 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10011087; BD EXTENSION SET SMALLBORE TUBING SmartSite VALVE (DETACHABLE), REF: 10011253; BD EXTENSION SET LOW SORBING TUBING 0.2 MICRON FILTER SmartSite VALVE, REF: 10013902; BD EXTENSION SET 2 SmartSite VALVES Y-CONNECTOR, REF: 10014692; BD EXTENSION SET SMALLBORE TUBING 2 DETACHABLE SmartSite VALVES, REF: 10015488; BD SmartSite NEEDLE FREE VALVE, REF: 2000E; BD Extension Set J-LOOP SMALLBORE Tubing SmartSite VALVE, REF: 20021E; BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 20035E; BD Extension Set SMALLBORE Tubing SmartSite VALVE SLIP LUER, REF: 20037E; BD Extension Set TRI-PORT SMALLBORE Tubing 3 SmartSite VALVES, REF: 20038E; BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 20039E; BD Extension Set SmartSite VALVE SLIP LUER, REF: 20057E; BD Extension Set SmartSite VALVE, REF: 20059E; BD extension Set Y-CONNECTOR 2 SmartSite VALVES, REF: 20061E; BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite VALVES, REF: 20062E; BD EXTENSION SET Y-CONNECTOR 2 SmartSite VALVE, REF: 20159E; BD Extension Set TRI-PORT SMALLBORE TUBING SmartSite VALVE DETACHABLE, REF: 20338E; BD EXTENSION SET SmartSite VALVE, REF: 21059E; BD 8.5-IN PRESSURE RATED EXTENSION SET SmartSite VALVE, REF: 22003E-07; BD Texium SmartSite VALVE MICROBORE EXTENSION SET 60 IN, REF: 22005E-07T; BD EXTENSION SET SmartSite VALVE (DETACHABLE), REF: 22059E; BD EXTENSION SET SmartSite VALVE (DETACHABLE) SLIP LUER, REF: C25015E; BD SmartSite Syringe-Syringe Transfer Device, REF: MV0450
20,874,700, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots: 20035964 21016575 20015157 20025207 20025243 20025244 20025245 20025246 20106552 20115468 20115469 21039510 20015758 20055744 20055745 20075637 20075638 20075639 20075673 20096017 20096018 21016323 20125462 20016553 20056551 20076494…
Every code shown here, 1,995 characters
Lots: 20035964 21016575 20015157 20025207 20025243 20025244 20025245 20025246 20106552 20115468 20115469 21039510 20015758 20055744 20055745 20075637 20075638 20075639 20075673 20096017 20096018 21016323 20125462 20016553 20056551 20076494 20075342 21026223 20075341 21016571 20015128 20015129 20015130 20015131 20015132 20015133 20015134 20015257 20015258 20015259 20015260 20015261 20015908 20015909 20015910 20015911 20016199 20016200 20016201 20016202 20016545 20016546 20016547 20016548 20016549 20016872 20016873 20016874 20016876 20017016 20017017 20017018 20017019 20017077 20017078 20017079 20017080 20017081 20017082 20017432 20017431 20017445 20017446 20017447 20025394 20025395 20025396 20025397 20025398 20025399 20025400 20025401 20025402 20025403 20025537 20025904 20025905 20025906 20025907 20025908 20026416 20026417 20026422 20026612 20026613 20026614 20026615 20026657 20026658 20026655 20026656 20035497 20035498 20035499 20035584 20035585 20035693 20035694 20035695 20035696 20035831 20035832 20035833 20035954 20035974 20035976 20035977 20035978 20035979 20036241 20045312 20045446 20045447 20045448 20045449 20045714 20045715 20045791 20045792 20045793 20045794 20045795 20045796 20045797 20045798 20046047 20046246 20046320 20046321 20046322 20046323 20046324 20046325 20046371 20046372 20046373 20046374 20046539 20046540 20046618 20046619 20046620 20046621 20046645 20046646 20046647 20046648 20046649 20086573 20085924 20085925 20086110 20086111 20087250 20095322 20095323 20095557 20095558 20105992 20106349 20106350 20106351 20106352 20106353 20106354 20106355 20115584 20115585 20115586 20115587 20115589 20115590 20115591 20115592 20115596 20115597 20115599 20115602 20115603 20115604 20115605 20115710 20116994 20116995 20116996 20116997 20116998 20125044 20125045 20125046 20125251 20125252 20125253 20125254 20125639 20125640 20125641 20125642 20125683 20125684 20125685 21016238 21016239 21016240 21025047 21025048 21025046 21025049 21025158 21025284 21025286…
FDA’s list runs to 10,562 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 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.”
- FDA’s list of codes runs to 10,562 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
-
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.