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FDA (Device enforcement)Recalled 2022-05-09class ii

Becton Dickinson & Company: Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)

Is my product affected?

Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)

  • UPC 382903836826

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson & Company is recalling Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue), catalog number 383682, distributed worldwide including throughout the United States and several countries in Asia, Europe, and beyond. The product may leak at the stopcock housing component, which could delay or interrupt medical treatment, expose patients to infusate and biohazardous material, result in under-dosing or under-infusion, cause contamination, or allow air to enter the system. A total of 44,040 units are affected across multiple lot numbers with expiration dates ranging from March 31, 2024 through July 31, 2024.

The recall affects patients and healthcare facilities that received this intravenous catheter product. The source document does not specify what remedy consumers or healthcare providers should pursue regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 44,040 Lot/code info: GTIN: 382903836826 Lot Numbers/Exp.Date: 1082423 3/31/2024 1117627 4/30/2024 1140859 5/31/2024 1210968 7/31/2024

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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