Device product
Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)
Z-1441-2022
Product summary
- Event
- Event 90304
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 44,040
- Official record key
device-enforcement:Z-1441-2022
Official wording
Reason: May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.
Code information: GTIN: 382903836826 Lot Numbers/Exp.Date: 1082423 3/31/2024 1117627 4/30/2024 1140859 5/31/2024 1210968 7/31/2024
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.
Derived failure modes
-
Unknown
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.