BD Connecta Stopcock Without Extension Tube Recalled for Potential Leakage Risk
Becton Dickinson & Company is recalling BD Connecta Stopcock units worldwide due to a potential housing leakage defect that could interrupt treatment or cause exposure 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: This is a Class II medical device with potential for leakage that could cause treatment interruption, exposure to biohazardous material, and underdosing. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet occurred.
Plain-English summary
BD Connecta Stopcock Without Extension Tube (Catalog No. 394605) manufactured by Becton Dickinson & Company is being recalled worldwide. The device may develop a leakage at the housing component, potentially resulting in treatment interruption, exposure to infusate and biohazardous material, underdosing, contamination, and air ingress.
The recall affects units distributed nationwide in the United States and internationally in Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, and Vietnam. Affected lot numbers have expiration dates ranging from January to April 2024.
The recalled product
- Product
- BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)
- Manufacturer
- Becton Dickinson & Company
Distribution
Part of a larger recall action
This product is one of 11 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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