FDAFDA · Food and drugs·Recall number Z-1723-2022
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.
Published September 21, 2022 · Recall initiated: August 1, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- 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.
- Lot
- Product Number: CH3771 UDI Code: 0110887709098678172702013050105782919 Lot Numbers: 5782919
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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