Z-0174-2023Class II

BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660...

Name: Z-0174-2023 BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660...
Creator: Becton Dickinson Infusion Therapy Systems Inc.
Published: 2022-10-12
License: https://open.fda.gov/license/

Becton Dickinson Infusion Therapy Systems Inc. / initiated 2022-10-12 / Open, Classified

FDA source

Becton Dickinson Infusion Therapy Systems Inc. began a recall of 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) on 2022-10-12. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0174-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-12
Posted: 2022-11-03
Recalling firm: Becton Dickinson Infusion Therapy Systems Inc.
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)
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
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 root 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: [email protected]
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
Product codes and lots: Catalog Number: 383516 UDI-DI Code: (01)00382903835164 Lot Number: 2168865

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0174-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0174-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-03

Product code FOZ

K183399Class IIBD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. / cleared 2019-03-20

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)