Z-0958-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2021
- Initiation Date
- December 2, 2020
- Termination Date
- June 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total Kits = 7,500 for all four lots
Product Description
154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - 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).
Reason for Recall
Due to the incorrect filter assembly.
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.
Code Information
Distributed O.U.S. only Model List Number: 011-H3182 UDI: (01)1084061905261(17)250401(30)50(10)4806428 Lot Number: 4806428