Device product
60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - 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-0955-2021
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-0955-2021
Official wording
Reason: Due to the incorrect filter assembly.
Code information: Model List Number: B2209 UDI: (01)10887709085439(17)250401(30)50(10)4794177 Lot Number: 4794177
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.