Class 2 Device Recall BD NEXIVA Closed IV Catheter System Dual Port18GA 1.25 IN

• Date Initiated by Firm: August 23, 2018
• Create Date: November 04, 2018
• Recall Status: Terminated on February 28, 2020
• Recall Number: Z-0384-2019
• Recall Event ID: 81040
• 510(K)Number: K032843
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539; ; Product Usage:; BD Nexiva Closed IV Catheter System Dual Port (hereafter referred to as BD Nexiva device or catheter) (see Figure below) incorporates a passive needle shielding mechanism that is activated as part of the usual insertion procedure when the needle is withdrawn from the catheter. BD Nexiva device is designed to protect the clinician from accidental needle stick injuries and minimize exposure to blood during the insertion process. The needle shield is designed to not release from the catheter adapter until the needle tip is protected and cannot be rearmed once activated. The BD Nexiva device is intended for use in the peripheral vascular system to provide access for the administration of fluids, medication, blood and blood products, and for the withdrawal of blood samples. This catheter may be used for any patient population with consideration given to patient size, appropriateness for solutions being infused and duration of therapy.
• Code Information: Lot 8087800, UDI (01)30382903835394
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Customer/Technical Support; 888-237-2762
• Manufacturer Reason for Recall: One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick injury.
• FDA Determined Cause: Under Investigation by firm
• Action: Urgent Medical Device Recall notification letters dated 8/23/18 were sent to customers. The letters instruct customers to perform the following actions: 1. Immediately review your inventory for the specific Catalogue (Ref) and lot number listed above and destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users of the product to ensure that they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program. Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 Actions Taken Distributors were instructed to: 1. Immediately review your inventory for the specific Catalogue (Ref) and lot number listed above and return all product subject to recall according to the Packing Instructions enclosed. 2. Identify all your customers that purchased any affected product, as defined in this recall notification. E-mail an excel file listing of all customers to BDMPSRC@bd.com, within 72 hours of receipt of this letter. 3. Complete the attached Wholesaler/Distributor Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your credit accordingly. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program. Web: MedWatch website at www.fda.gov/medwatch Phone: 1
• Quantity in Commerce: 133,230 units
• Distribution: Worldwide Distribution -US Nationwide in the states of: CA, CO, FL, GA, IL, LA, MI, ND, NE, NY, OH, PA, RI, SC, VA, WA and WV. The products were distributed to the following foreign countries: Argentina, Australia, Belgium, Brazil, Canada, Colombia, Costa Rica, Mexico and New Zealand.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FOZ and Original Applicant = BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.