The Recall Desk
HighFDA (Devices)·Z-1432-2022·Announced 2022-07-27

BD Connecta Stopcock Recalled for Potential Housing Leakage

Becton Dickinson is recalling its BD Connecta Stopcock due to potential leakage at the housing component, which may interrupt treatment and 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 an FDA Class II recall with no reported illnesses or injuries. The hazard involves potential leakage that could result in treatment interruption and biohazard exposure, constituting a risk-of-harm product where injury has not yet been reported, meeting the criteria for High severity.

Plain-English summary

Becton Dickinson & Company is recalling the BD Connecta Stopcock Without Extension Tube (Catalog No. 394600). Approximately 2.8 million units are affected.

The stopcock may have potential for leakage at the housing component. This could result in treatment delay or interruption, exposure to infusate and biohazardous material, under-dosing, contamination, and/or air ingress.

The product was distributed in the United States and internationally, including Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, and Vietnam.

Patients and healthcare providers should stop using affected units immediately. Contact your healthcare provider or Becton Dickinson for guidance on replacement products.

The recalled product

Product
BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
Manufacturer
Becton Dickinson & Company
Category
Medical Device
Hazard
  • leakage
  • treatment-interruption
  • biohazard-exposure
  • under-dosing

Distribution

Distributed nationwide across the United States.

Related recalls

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