Class 2 Device Recall BD Nexiva Closed IV Catheter System

• Date Initiated by Firm: October 12, 2022
• Date Posted: November 03, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0174-2023
• Recall Event ID: 90972
• 510(K)Number: K183399
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• 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)
• Code Information: Catalog Number: 383516 UDI-DI Code: (01)00382903835164 Lot Number: 2168865
• Recalling Firm/ Manufacturer: Becton Dickinson Infusion Therapy Systems Inc.; 9450 S State St; Sandy UT 84070-3213
• For Additional Information Contact: Mr. Eric Borin; 201-847-3121
• Manufacturer 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).
• FDA Determined Cause: Storage
• Action: On 10/12/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx and email, to customers informing them that Becton, Dickinson (BD) confirmed that during withdrawal of the Nexiva product, the tip shield may prematurely separate from the catheter adapter and prevent the needle tip from being safely shielded. As a result, the clinicians could potentially experience a contaminated needlestick injury after withdrawal of the needle. Customers are instructed to: 1. Immediately review their inventory for the specific Catalog (Ref) and Lot number listed above. Destroy all unused product subject to the recall following their institution s process for destruction. 2. For indwelling catheters, no further action is needed. As indicated, these catheters can remain in place and continue to be used per the Instructions for Use. 3. If the affected product was previously used in patient care, no further action is needed. 4. Share this recall notification with all users within their facility network of the product to ensure they are also aware of this recall. 5. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not they have any of the impacted material so that BD may acknowledge their receipt of this notification per FDA requirements and subsequently process your product replacement. For questions - contact North America Regional Complaint Center at Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
• Quantity in Commerce: 56,080 units
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FOZ and Original Applicant = Becton Dickinson Infusion Therapy Systems Inc.