Nexiva IV Catheter Stopcock May Leak During Infusion
Becton Dickinson is recalling specific lots of Nexiva IV catheters because the stopcock housing may leak, potentially interrupting treatment and exposing 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 harm including air ingress and exposure to biohazardous material, but no reported injuries or illnesses. It meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Company is recalling specific lot numbers of Nexiva IV catheters with a single BD Connecta stopcock (20 gauge, blue, catalog number 383682) that were distributed internationally. Approximately 44,040 units are affected with lot numbers and expiration dates ranging from March 2024 to July 2024.
The stopcock housing component may develop leakage during use. A leaking stopcock can interrupt or delay patient treatment, allow medication and biohazardous material to escape, result in inadequate medication delivery to the patient, and allow air to enter the infusion line.
Affected products were distributed to numerous U.S. states (Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and West Virginia) and internationally to Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, and Vietnam. Healthcare facilities should identify affected catheters using the provided lot numbers and expiration dates and remove them from service immediately.
The recalled product
- Product
- Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)
- Manufacturer
- Becton Dickinson & Company
- Hazard
- leakage
- air-ingress
- biohazard-exposure
- underdosing
Distribution
Distributed nationwide across the United States.
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