ICU Medical, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1723-2022)

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:

6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.

Product Classification:

Class II

Date Initiated: August 1, 2022

Date Posted: September 21, 2022

Recall Number: Z-1723-2022

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: CH3771 UDI Code: 0110887709098678172702013050105782919 Lot Numbers: 5782919

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