Z-1723-2022 Class II Ongoing
FDA device recall Z-1723-2022 was initiated by ICU Medical, Inc. on Aug 1, 2022 and is designated Class II. Reason for recall: Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. The recall status is ongoing. Affected quantity: Total of all affected units = 5,795,989 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 21, 2022
- Initiation Date
- Aug 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total of all affected units = 5,795,989 units
Product Description
Reason for Recall
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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1723-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026