The Recall Desk
HighFDA (Devices)·Z-1436-2022·Announced 2022-07-27

BD Connecta 3-Way Stopcocks Recalled Due to Potential Leakage

Becton Dickinson recalls BD Connecta 3-Way Stopcocks due to potential leakage at the housing that may delay 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: FDA Class II recall of a medical device with potential for serious patient harm including treatment interruption, biohazard exposure, and under-dosing. No injuries have been reported. Per the rubric, this qualifies as High (Score 3) for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Company is recalling BD Connecta 3-Way Stopcocks (Catalog No. 394900, OUS) due to a potential manufacturing defect that may allow leakage at the housing component of the stopcock.

The affected units (54010 total) were distributed worldwide, including to hospitals and healthcare facilities across the United States and internationally to Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, and Vietnam. The affected lot number is 1214380 with an expiration date of July 31, 2024.

A leak in the stopcock may result in treatment delay or interruption, exposure of patients to infusate and biohazardous material, under-dosing or under-infusion, contamination, and air ingress into the infusion line. No injuries or illnesses have been reported.

Healthcare facilities and individuals using units from the affected lot should contact their medical device supplier or Becton Dickinson directly for return or replacement instructions.

The recalled product

Product
BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)
Manufacturer
Becton Dickinson & Company
Category
Medical Device — Infusion therapy equipment
Hazard
  • leakage
  • treatment-delay
  • biohazard-exposure
  • under-infusion
  • contamination
  • air-ingress

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: 382903949007 Lot Numbers/Exp.Date: 1214380 7/31/2024

Distribution

Distributed nationwide across the United States.

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