Z-1710-2019Class II

BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system...

Name: Z-1710-2019 BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system...
Creator: Becton Dickinson & Company
Published: 2019-03-01
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-03-01 / Terminated

FDA source

Becton Dickinson & Company began a recall of BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536 on 2019-03-01. FDA classified it as Class II and gives the reason as "Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1710-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-01
Posted: 2019-06-03
Terminated: 2020-05-21
Recalling firm: Becton Dickinson & Co
Product: BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.
FDA root cause: Release of Material/Component prior to receiving test results
Action: BD MDS (Medication Delivery Solutions) contacted via email and provided a hard copy letter via FedEx on March 1, 2019. The tetter describes the problem , action to take: Immediately review your inventory for the specific Catalog and lot number listed above.Destroy all product subject to the recall following your institutions process for destruction. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. . 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 BD is requesting the distributor to identify their customers and either notify their customers regarding the recall or provide BD a customer list. BD will mail additional communications to the customers that are identified on the lists provided by the distributor. Questions: Customer/Technical Support 888-237-2762 OPT 3, OPT 2 Monday Friday between 8:00am and 5:00pm (EST
Quantity in commerce: 6,720 units
Distribution: US distribution to one distributor in VA.
Product codes and lots: Lot Number: 8337721 Exp. 30-Nov-2021 UDI: 382903835362

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1710-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1710-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-03

Product code FOZ

K161777Class IIBD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. / cleared 2016-08-29

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)