Z-0955-2021 Class II Terminated
FDA device recall Z-0955-2021 was initiated by ICU Medical, Inc. on December 2, 2020 and is designated Class II. Reason for recall: Due to the incorrect filter assembly. The recall status is terminated (terminated June 30, 2023). Affected quantity: Total Kits = 7,500 for all four lots.
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
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).
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
Model List Number: B2209 UDI: (01)10887709085439(17)250401(30)50(10)4794177 Lot Number: 4794177