BD Connecta Plus3 infusion connector recalled for potential stopcock leakage
Becton Dickinson is recalling BD Connecta Plus3 White Blend infusion connectors (Lot 1127328) due to potential stopcock leakage. The defect may interrupt treatment, expose patients to biohazardous material, or cause under-infusion.
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 medical device recall for a risk-of-harm product with potential for serious patient complications including treatment interruption, medication under-dosing, and exposure to biohazardous material. No illnesses or injuries have been reported, which per the severity rubric limits the score to 3.
Plain-English summary
Becton Dickinson & Company has recalled BD Connecta Plus3 White Blend OEM infusion connectors (Catalog No. 395214, Lot 1127328) due to a potential defect in the stopcock housing component. These sterile connectors are used in medical infusion systems.
The defect may cause leakage, which could delay or interrupt medical treatment, expose patients and healthcare workers to infusate and biohazardous material, result in inadequate medication delivery (under-infusion), cause contamination, or allow air to enter the infusion line.
The recalled devices have been distributed worldwide, including throughout the United States and internationally to Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, and Vietnam.
The recalled product
- Product
- BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)
- Manufacturer
- Becton Dickinson & Company
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: N/A Lot Numbers/Exp.Date: 1127328
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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