The Recall Desk
HighFDA (Devices)·Z-1435-2022·Announced 2022-07-27

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
Hazard
  • leakage
  • treatment-interruption
  • biohazardous-exposure
  • underdosing

Distribution

Distributed nationwide across the United States.