The Recall Desk
HighFDA (Devices)·Z-1440-2022·Announced 2022-07-27

Nexiva Infusion Device Stopcock May Leak During Treatment

Becton Dickinson is recalling Nexiva infusion devices with pink stopcock components due to potential leakage at the housing that could interrupt treatment or expose patients to infusate 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 is an FDA Class II recall of a medical device with potential for serious patient harm, including treatment interruption and exposure to biohazardous material. No illnesses or injuries have been reported to date, which per the rubric limits the score to 3 (High) rather than 4 (Severe).

Plain-English summary

Becton Dickinson & Company is recalling approximately 40,050 Nexiva infusion devices with Single BD Connecta Stopcock Version (Pink, Catalog No. 383687) due to a potential leakage hazard at the housing component of the stopcock.

The leakage may result in interruption or delay of treatment, exposure to infusate (the fluid being infused) and biohazardous material, under-dosing or under-infusion, contamination, and air ingress into the infusion line. These devices are used in hospitals and healthcare settings for intravenous therapy and medication delivery.

The affected devices were distributed worldwide, including throughout the United States. Specific lot numbers with expiration dates ranging from March 31, 2024 through July 31, 2024 are involved. Healthcare facilities that have received affected devices should stop use and contact Becton Dickinson & Company for instructions on replacement or return.

Patients or healthcare providers with questions about affected devices should contact Becton Dickinson & Company with the recall information provided.

The recalled product

Product
Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)
Manufacturer
Becton Dickinson & Company
Hazard
  • leakage
  • treatment-interruption
  • biohazard-exposure
  • under-dosing
  • air-ingress

Distribution

Distributed nationwide across the United States.