ICU Medical, Inc. Recall 87703
Description: REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
ICU Medical, Inc. Recall 87703 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1573-2021 |
| Event ID | 87703 |
| Event Description | REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). |
| Product Type | Devices |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain, United Kingdom. |
| Recall Reason | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. |
| Device Classification | 20210519 |
| Device Code Info | REF: CL3946 UDI: (01) 1 0887709 08029 1 (17) 260101 (30) 50 (10) 5142959 Lot Number: 5142959 |
| Center Classification Date | 20210513 |
| Recall Initiation Date | 20210316 |
| Recalling Firm | ICU Medical, Inc. |
| Initial Notification | Letter |
| Similar To |