The Recall Desk
HighFDA (Devices)·Z-1437-2022·Announced 2022-07-27

BD Connecta Plus1 360 Infusion Connector: Potential Housing Leakage

Becton Dickinson is recalling certain BD Connecta Plus1 360 Blue Blend infusion connectors due to potential leakage at the housing stopcock that could interrupt treatment and expose patients to contamination and 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 Class II medical device recall involves potential leakage that could result in treatment interruption and exposure to biohazardous material. No illnesses or injuries have been reported and the hazard is described as potential rather than confirmed, placing this at the High severity level per the rubric criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Company is recalling BD Connecta Plus1 360 Blue Blend infusion connectors (Catalog No. 394911) due to potential leakage at the housing component of the stopcock. The leakage could result in treatment delay or interruption, exposure to infusate and biohazardous material, underdosing or under-infusion, contamination, and air ingress.

The recall affects approximately 9,010 units with worldwide and US distribution including multiple states (AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV) and international countries (Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam). The affected lot number is 1061512 with expiration date February 29, 2024 (GTIN 382903949113).

No illnesses or injuries have been reported to date. Patients and healthcare facilities using these connectors should contact Becton Dickinson & Company for replacement and recall instructions.

The recalled product

Product
BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)
Manufacturer
Becton Dickinson & Company
Category
Medical Device — Infusion Connector
Hazard
  • leakage
  • treatment-interruption
  • biohazard-exposure
  • underdosing

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: 382903949113 Lot Numbers/Exp.Date: 1061512 2/29/2024

Distribution

Distributed nationwide across the United States.

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