BD Connecta Stopcock Recalled for Potential Housing Leakage
Becton Dickinson is recalling approximately 1.96 million BD Connecta Stopcock devices due to potential leakage at the housing component, which could interrupt treatment and expose patients to biohazardous material.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with potential for serious adverse outcomes including treatment delay, biohazard exposure, and contamination. No reported illnesses or injuries; the hazard remains theoretical, meeting the criteria for High severity.
Plain-English summary
Becton Dickinson & Company is recalling approximately 1,960,360 units of the BD Connecta Stopcock Without Extension Tube (Catalog No. 394601) due to potential leakage at the housing component.
The stopcock may develop leakage at the housing, which could result in delay or interruption of infusion treatment, exposure to infusate and biohazardous material, under-dosing or under-infusion, contamination, and air ingress. These potential hazards could affect patient safety during critical medical treatment.
The recalled devices were distributed worldwide, including nationwide distribution across the United States and in Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, and Vietnam. The FDA has identified specific lot numbers and expiration dates for the recalled units.
The recalled product
- Product
- BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Infusion Device
- Hazard
- leakage
- treatment-delay
- biohazard-exposure
- contamination
Distribution
Distributed nationwide across the United States.
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