The Recall Desk
HighFDA (Devices)·Z-1438-2022·Announced 2022-07-27

BD Connecta White 360 Infusion Connector Recalled for Potential Leakage

Becton Dickinson recalls BD Connecta White 360 infusion connectors for potential leakage at the stopcock housing. The defect may interrupt treatment and expose patients to biohazardous materials.

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 recall involving a risk-of-harm defect (potential leakage in an infusion delivery system) with no reported illnesses, injuries, or deaths. Per the rubric, recalls involving risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

Becton Dickinson & Company is recalling the BD Connecta White 360 Shelf infusion connectors (Catalog No. 395000) distributed worldwide. The product is used in intravenous infusion delivery systems.

The recall addresses a potential defect in the stopcock housing component that may cause leakage. A leak could result in treatment delay or interruption, exposure to infusate and biohazardous material, under-infusion or incomplete drug delivery, contamination, and air ingress into the infusion line.

Approximately 448,040 units were distributed to multiple US states and internationally to Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, and Vietnam. Affected lot numbers are 1120604 (exp. 3/31/2024), 1098929 (exp. 3/31/2024), 1123643 (exp. 4/30/2024), and 1063423 (exp. 2/29/2024).

Healthcare providers should immediately discontinue use of affected units and contact Becton Dickinson for replacement instructions. Patients receiving infusion therapy through this connector should be monitored for signs of treatment interruption or other adverse effects.

The recalled product

Product
BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)
Manufacturer
Becton Dickinson & Company
Hazard
  • leakage
  • treatment-interruption
  • contamination
  • biohazard-exposure

Distribution

Distributed nationwide across the United States.