ICU Medical, Inc. recalls MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed i

Recalled September 21, 2022 · FDA recall Z-1719-2022 · ICU Medical

Hazard

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

Units

Total of all affected units = 5,795,989 units

Sold at

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.

Description

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

Product

MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.

Manufacturer(s)

ICU Medical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →