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)
Summary
The FDA issued a Class II for BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 by Becton Dickinson Infusion Therapy Systems Inc.. Reason: During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shi.
Details
Source
Device Recall
External ID
Z-0174-2023
Action Date
2022-11-09
Status
Ongoing
Category
device
Product Description
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)
Lot/Code Info: Catalog Number: 383516 UDI-DI Code: (01)00382903835164 Lot Number: 2168865
Quantity Affected: 56,080 units
Reason for Recall
During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).
Distribution
U.S.: New York, Florida, Maryland, North Carolina, Virginia, Georgia, Rhode Island, New Jersey, Pennsylvania, Illinois, South Carolina, Maine, and Massachusetts. O.U.S.: N/A
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-12
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 124 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Becton Dickinson Infusion Therapy Systems Inc. has 25 FDA actions in our database, including 15 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Becton Dickinson Infusion Therapy Systems Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Becton Dickinson Infusion Therapy Systems Inc. have FDA actions?
Becton Dickinson Infusion Therapy Systems Inc. has 25 FDA actions in our database, including 15 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0174-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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