ICU Medical, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1722-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set

Product Classification:

Class II

Date Initiated: August 1, 2022

Date Posted: September 21, 2022

Recall Number: Z-1722-2022

Event ID: 90726

Reason for Recall:

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

Status: Ongoing

Product Quantity: Total of all affected units = 5,795,989 units

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated