BD Connecta Stopcock recalled for potential housing leakage risk
Becton Dickinson is recalling BD Connecta Stopcocks due to potential leakage at the housing component. The defect may 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: This is an FDA Class II recall with no reported illnesses or injuries. However, the product defect poses a risk of serious harm—including treatment interruption and exposure to biohazardous material—even though such injuries have not yet been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Company is recalling the BD Connecta Stopcock Without Extension Tube (Catalog No. 394602) due to a potential defect in the housing component that may cause leakage.
The affected product was distributed worldwide and in the United States across multiple states. Approximately 2,100,210 units are affected by this recall. Specific lot numbers and expiration dates are available from the FDA.
The potential leakage may result in treatment delay or interruption, exposure to infusate and biohazardous material, under-dosing or under-infusion, contamination, and air ingress. Healthcare facilities and providers using this product should review the affected lot numbers and expiration dates. If your facility has received affected units, contact Becton Dickinson & Company for instructions on replacement or return.
The recalled product
- Product
- BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)
- Manufacturer
- Becton Dickinson & Company
- Hazard
- leakage
- under-infusion
- biohazard-exposure
- air-ingress
- contamination
Distribution
Distributed nationwide across the United States.
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