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Recall Observatory FDA recall evidence

Device product

BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)

Z-1438-2022

May 09, 2022

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 90304
Status
Ongoing
Classification
Class II
Quantity
448,040
Official record key
device-enforcement:Z-1438-2022

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: 382903950003 Lot Numbers/Exp.Date: 1120604 3/31/2024 1098929 3/31/2024 1123643 4/30/2024 1063423 2/29/2024

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.