ICU Medical, Inc. Recall 90726
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.
ICU Medical, Inc. Recall 90726 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1723-2022 |
| Event ID | 90726 |
| Event 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. |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | Total of all affected units = 5,795,989 units |
| Recall Reason | Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. |
| Device Classification | 20220921 |
| Device Code Info | Product Number: CH3771 UDI Code: 0110887709098678172702013050105782919 Lot Numbers: 5782919 |
| Center Classification Date | 20220909 |
| Recall Initiation Date | 20220801 |
| Recalling Firm | ICU Medical, Inc. |
| Initial Notification | Letter |
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