Z-0384-2019Class II

BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539

Name: Z-0384-2019 BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539
Creator: Becton Dickinson & Company
Published: 2018-08-23
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-08-23 / Terminated

FDA source

Becton Dickinson & Company began a recall of 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... on 2018-08-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0384-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-23
Posted: 2018-11-04
Terminated: 2020-02-28
Recalling firm: Becton Dickinson & Co
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a passive needle shielding mechanism that is activated as part of the usual insertion procedure when the needle is withdrawn from the catheter.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.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
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 root 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 [email protected], 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.
Product codes and lots: Lot 8087800, UDI (01)30382903835394

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0384-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0384-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-03

Product code FOZ

K032843Class IINexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. / cleared 2004-02-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)