6.5” (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock
Medical device recall Z-1721-2022. 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?
6.5” (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
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 Number: 011-MC33538 UDI Code: 0110840619072435172701013050105772700 Lot Numbers: 5772700 Product Number: A1009 UDI Codes: 0110887709051055172612013050105747112 Lot Numbers: 5747112 Product Number: A1129 UDI Code:…
Every code shown here, 1,999 characters
Product Number: 011-MC33538 UDI Code: 0110840619072435172701013050105772700 Lot Numbers: 5772700 Product Number: A1009 UDI Codes: 0110887709051055172612013050105747112 Lot Numbers: 5747112 Product Number: A1129 UDI Code: 0110887709068190172612013050105755485 0110887709068190172701013050105772087 Lot Number 5755485 5772087 Product Number: AC235 UDI Code: 0110887709122069172702013050105782946 Lot Number: 5782946 Product Number: MB4V01 UDI Code: 0110887709079578172701013050105797658 Lot Number: 5797658 Product Number: MC330073 UDI Codes: 0110887709076690172612013050105724537 Lot Numbers: 5724537 Product Number: MC330255 UDI Codes: 0110887709081670172611013050105712884 Lot Numbers: 5712884 Product Number: MC3302R UDI Codes: 0110887709037271172612013050105745628 Lot Numbers: 5745628 Product Number: MC330362 UDI Code: 0110887709085319172701013050105772361 Lot Number: 5772361 Product Number: MC330417 UDI Code: 0110887709087504172701013050105782954 0110887709087504172702013050105816260 Lot Number: 5782954 5816260 Product Number: MC330476 UDI Codes: 0110887709090030172611013050105677797 0110887709090030172611013050105692512 0110887709090030172612013050105721748 Lot Numbers: 5677797 5692512 5721748 Product Number: MC330583 UDI Codes: 0110887709095868172701013050105773172 Lot Numbers: 5773172 Product Number: MC330611 UDI Codes: 0110887709097022172702013025105825526 0110887709097022172702013025105850314 Lot Numbers: 5825526 5850314 Product Number: MC330615 UDI Code: 0110887709097091172701013050105773186 0110887709097091172701013050105776699 Lot Number: 5773186 5776699 Product Number: MC33087 UDI Codes: 0110887709037349172612013050105732851 0110887709037349172701013050105757039 Lot Numbers: 5732851 5757039 Product Number: MC33092 UDI Code: 0110887709037356172612013050105757043 Lot Number: 5757043 Product Number: MC33119 UDI Code: 0110887709037394172611013050105692600 0110887709037394172612013050105725019 0110887709037394172701013050105777549 Lot Number: 5692600 5725019 5777549…
FDA’s list runs to 5,465 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 5,465 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.