BD Nexiva IV Catheter May Leave Needle Tip Exposed During Withdrawal
The BD Nexiva Closed IV Catheter System tip shield may separate prematurely during needle withdrawal, leaving the needle tip exposed. This affects 56,080 units distributed across multiple U.S. states.
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 medical device with a structural defect that creates a risk of needle-stick injury due to exposed needle tip. No injuries or adverse events are reported in the source material. Per the rubric, risk-of-harm products without reported injury are classified as High (3).
Plain-English summary
The BD Nexiva Closed IV Catheter System (REF 383516, Lot 2168865) is being recalled by Becton Dickinson Infusion Therapy Systems Inc. A total of 56,080 units have been distributed in the United States.
During needle withdrawal, the tip shield may separate prematurely from the catheter adapter, leaving the needle tip exposed rather than safely shielded. This creates a potential risk of needle-stick injury to patients and healthcare workers.
The affected units were distributed to healthcare facilities in the following states: New York, Florida, Maryland, North Carolina, Virginia, Georgia, Rhode Island, New Jersey, Pennsylvania, Illinois, South Carolina, Maine, and Massachusetts. Patients and healthcare providers who have received this product should consult their healthcare provider regarding further guidance and the status of their specific units.
The recalled product
- Product
- BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr)
- Manufacturer
- Becton Dickinson Infusion Therapy Systems Inc.
- Category
- Medical Device — IV Catheter
- Hazard
- exposed-needle
- device-failure
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)
- Catalog Number: 383516 UDI-DI Code: (01)00382903835164 Lot Number: 2168865
Distribution
Distribution scope not specified by the agency.
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