FDA Medical Device Recalls (openFDA)
Becton Dickinson Infusion Therapy Systems Inc.: 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)
- Recall number
- Z-0174-2023
- 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)
- Status
- Open, Classified
- Initiated
- 2022-10-12
- Posted
- 2022-11-03
- Terminated
- not on file
- Reason
- 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).
- 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: productcomplaints@bd.com
- Quantity
- 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
- Lot, serial or model codes
- Catalog Number: 383516 UDI-DI Code: (01)00382903835164 Lot Number: 2168865
- 510(k) numbers
- ["K183399"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 1710034
- Firm city
- Sandy
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28