Z-1723-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 21, 2022
- Initiation Date
- August 1, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total of all affected units = 5,795,989 units
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.
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: CH3771 UDI Code: 0110887709098678172702013050105782919 Lot Numbers: 5782919