Recall archive / FDA device enforcement
MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Vo... — FDA record Z-1722-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 1, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set
- Reason
- Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
- Classification
- Class II
- Recalling firm
- ICU Medical, Inc.
- Quantity
- Total of all affected units = 5,795,989 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1722-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Product Number: 011-MC100 UDI Code: 01108406190425061726120130100105737404 01108406190425061726120130100105740700 01108406190425061726120130100105740701 01108406190425061726120130100105740702 01108406190425061726120130100105740703 01108406190425061726120130100105740705 01108406190425061726120130100105740706 01108406190425061726120130100105740707 01108406190425061726120130100105740708 01108406190425061726120130100105740712 01108406190425061726120130100105740713 01108406190425061726120130100105740714 01108406190425061726120130100105740715 01108406190425061726120130100105740719 01108406190425061726120130100105740721 01108406190425061727010130100105793254 01108406190425061727010130100105793255 01108406190425061727010130100105793259 Lot Numbers: 5737404 5740700 5740701 5740702 5740703 5740705 5740706 5740707 5740708 5740712 5740713 5740714 5740715 5740719 5740721 5793254 5793255 5793259 Product Number: MR4001 UDI Codes: 01108877090796081726120130100105738132 Lot Numbers: 5738132 Product Number: MS984 UDI Code: 01108424721008291726120130100105737492 Lot Number 5737492 Product Number: SC3000 UDI Code: 01108877090818301726120130100105726857 01108877090818301726120130100105753967 Lot Number: 5726857 5753967 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- 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
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 21, 2022
- Recall initiation date
- Aug 1, 2022
- Center classification date
- Sep 9, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.