Device product
Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)
Z-1440-2022
Product summary
- Event
- Event 90304
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 40,050
- Official record key
device-enforcement:Z-1440-2022
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: 382903836871 Lot Numbers/Exp.Date: 1082428 3/31/2024 1097856 3/31/2024 1111860 4/30/2024 1188909 6/30/2024 1208182 7/31/2024 1179403 6/30/2024
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.