MicroClave Clear Neutral Connector
Medical device recall Z-1719-2022. 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?
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.
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: MC100 UDI Code: 01108877090371581726110130100105716986 01108877090371581726110130100105716988 01108877090371581726110130100105716989 01108877090371581726110130100105716990 01108877090371581726110130100105716992…
Every code shown here, 1,970 characters
Product Number: MC100 UDI Code: 01108877090371581726110130100105716986 01108877090371581726110130100105716988 01108877090371581726110130100105716989 01108877090371581726110130100105716990 01108877090371581726110130100105716992 01108877090371581726110130100105716993 01108877090371581726110130100105716994 01108877090371581726120130100105737649 01108877090371581726120130100105737651 01108877090371581726120130100105739477 01108877090371581726120130100105739478 01108877090371581726120130100105739482 01108877090371581726120130100105739484 01108877090371581726120130100105739493 01108877090371581726120130100105755652 01108877090371581726120130100105757425 01108877090371581726120130100105757426 01108877090371581727010130100105771936 01108877090371581727010130100105771950 01108877090371581727010130100105771956 01108877090371581727010130100105786565 01108877090371581727010130100105815050 Lot Numbers: 5716986 5716988 5716989 5716990 5716992 5716993 5716994 5737649 5737651 5739477 5739478 5739482 5739484 5739493 5755652 5757425 5757426 5771936 5771950 5771956 5786565 5815050 Product Number: 12512-01 UDI Codes: 01108877090505391726120130100105724458 01108877090505391726120130100105736445 01108877090505391726120130100105739485 01108877090505391726120130100105739486 01108877090505391726120130100105739487 01108877090505391726120130100105739488 01108877090505391726120130100105754899 01108877090505391727010130100105771934 01108877090505391727010130100105793264 01108877090505391727010130100105798239 01108877090505391727010130100105802842 01108877090505391727020130100105812522 Lot Numbers: 5724458 5736445 5739485 5739486 5739487 5739488 5754899 5771934 5793264 5798239 5802842 5812522 Product Number: MC100-PR UDI Code: 01108877090372021726120130100105738352 Lot Number 5738352 Product Number: MC330446 UDI Code: 0110887709089096172612013050105746457 Lot Number: 5746457 Product Number: MC330545 UDI Code: 0110887709093222172701013050105773182 Lot Number: 5773182
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.”
- 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.