Z-1722-2022 Class II Ongoing
Recalled by ICU Medical, Inc.
— San Clemente, CA
FDA device recall Z-1722-2022 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
MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set
Reason for Recall
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
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
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1722-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it.