Recall archive / FDA device enforcement
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter place... — FDA record Z-1719-2022
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. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.
- 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-1719-2022
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: 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 |
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.