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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 2,800,270
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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