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Recall Observatory FDA recall evidence

Device product

Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)

Z-1440-2022

May 09, 2022

Class II

Product summary

Firm
Becton Dickinson & Company
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

    reason.no_named_rule · v1.0.0

    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.