6” (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating…
Medical device recall Z-1724-2022. Published in FDA’s Enforcement Report on Sep 21, 2022.
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 21, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 53 states named in where it went
- Total of all affected units = 5,795,989 units 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?
Due to a manufacturing defect which results in a visible gap between the connector’s top and bottom housing.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
6” (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;
Total of all affected units = 5,795,989 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Numbers / Lot Numbers / UDI Codes: IR-1SF 5727531 01549878920700181724120130100105727531 IR-1S 5728008 01549878920698901724120130100105728008 IR-1SF 5737373 01549878920700181724120130100105737373 IR-1S 5738091…
Every code shown here, 1,964 characters
Product Numbers / Lot Numbers / UDI Codes: IR-1SF 5727531 01549878920700181724120130100105727531 IR-1S 5728008 01549878920698901724120130100105728008 IR-1SF 5737373 01549878920700181724120130100105737373 IR-1S 5738091 01549878920698901724120130100105738091 IR-1S 5755100 01549878920698901724120130100105755100 P039 5787453 0110840619063112172501013050105787453 MC33769 5664461 0110887709066844172610013050105664461 K7059-001 5692316 0110887709036977172611013050105692316 011-MC100G 5693573 01108406190790141726110130100105693573 LAT-MC100 5714006 01108877090962851726110130100105714006 LAT-MC330021 5714014 0110887709122144172611013050105714014 MC100-DC 5724498 0110887709037165172612013050105724498 MC33636 5725526 0110887709058108172612013050105725526 MC33691 5725559 0110887709064314172612013050105725559 011-MC100RR 5726283 01108406190539771726120130100105726283 011-AM3120 5726777 0110887709098876172612013025105726777 066-MC100 5735598 01108406190842231726120130100105735598 039-MC330487 5736333 0110840619098541172612013025105736333 011-H3095 5737883 0110840619043015172612013025105737883 011-MC330627 5738780 0110887709098531172612013050105738780 MC33687 5744883 0110887709064369172612013050105744883 011-MC330526 5746749 0110887709092232172612013050105746749 011-MC33428 5747264 0110840619072336172612013025105747264 011-MC33830 5747331 0110840619038578172612013025105747331 011-MC33230 5747967 0110840619064492172612013050105747967 MC33324 5753823 0110887709037738172612013025105753823 MC33467 5754104 0110887709039046172612013025105754104 MC33769 5754294 0110887709066844172612013050105754294 011-MC330164 5756448 0110840619091085172612013020105756448 011-MC33108 5757000 0110840619057838172612013050105757000 MC33688 5757503 0110887709064376172612013050105757503 011-MC33727 5758006 0110840619077713172612013050105758006 011-A1027 5759727 0110840619064676172261201350105759727 011-MC330283 5761603 0110840619092914172612013050105761603 MC33324 5762312…
FDA’s list runs to 3,771 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.
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Austria, Bahrain, Belgium, Canada, Colombia, Estonia, France, Germany, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam. O.U.S.
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
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 1, 2022.
- FDA classified it on Sep 9, 2022.
- FDA’s Enforcement Report published it on Sep 21, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- ICU Medical, Inc., of San Clemente, 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 3,771 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.