Device product
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which 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).
Z-0957-2021
Product summary
- Event
- Event 86973
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total Kits = 7,500 for all four lots
- Official record key
device-enforcement:Z-0957-2021
Official wording
Reason: Due to the incorrect filter assembly.
Code information: Model List Number: Z3532 UDI: (01)10887709033174(17)250401(30)50(10)4795091 Lot Number: 4795091
Distribution pattern: Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA and WV. The country of Belgium.
Derived failure modes
-
Unknown
Due to the incorrect filter assembly.