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

Becton Dickinson & Company: BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)

Is my product affected?

BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)

  • UPC 382903949113

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

What happened

Becton Dickinson & Company is recalling BD Connecta Plus 360 Blue Blend infusion connectors (Catalog No. 394911) distributed worldwide, including across most U.S. states and multiple countries in Asia, Europe, and South Asia. The recall affects 9,010 units with lot number 1061512 and expiration date of 2/29/2024 (GTIN: 382903949113). The devices may leak at the stopcock housing component, which could delay or interrupt medical treatment, expose patients to infusate and biohazardous materials, result in under-dosing or under-infusion, or allow contamination and air to enter the system.

The recall notice does not specify a remedy or recommended course of action for affected consumers.

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: 9,010 Lot/code info: GTIN: 382903949113 Lot Numbers/Exp.Date: 1061512 2/29/2024

Source

Official record: FDA (Device enforcement) ↗

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

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