The Recall Desk
HighFDA (Devices)·Z-0306-2022·Announced 2021-12-01

BD Nexiva IV Catheters Recalled Due to Non-Sterile Packaging Breach

Becton Dickinson is recalling BD Nexiva IV catheter systems because of a packaging breach that renders them non-sterile. The recall affects 155,840 devices distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a critical medical device with a sterility breach. While no illnesses or injuries have been reported, non-sterile IV catheters present an inherent risk of serious infection, placing this in the High severity category per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

BD Nexiva closed IV catheter systems (20 GA, 1.00 inch, Catalog Number 383536) are being recalled by Becton Dickinson Infusion Therapy Systems Inc. These are over-the-needle, intravascular catheters designed for short-term vascular access to sample blood, monitor blood pressure, or administer fluids.

The recall stems from a breach in the product packaging that renders the devices non-sterile. Non-sterile IV catheters present a significant risk of infection if used in patients.

The recall affects 155,840 devices that were distributed nationwide throughout the United States. The affected lot numbers are 1193055, 1166273, and 1188953, all with an expiration date of June 30, 2024.

Healthcare facilities and individuals in possession of these devices should not use them and should contact Becton Dickinson Infusion Therapy Systems Inc. for replacement or proper disposal instructions.

The recalled product

Product
BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV cat
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
Category
Medical Device — IV Catheters
Hazard
  • non-sterile
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Catalog number/Model number: 383536
  • 2024-06-30
  • Lot: 1166273: (17)240630(10)1166273(30)80/(01)50382903835367
  • 2024-06-30 Lot: 1166273: (17)240630(10)1166273(30)80/(01)50382903835367
  • 2024-06-30 Lot: 1188953: (17)240630(10)1188953(30)80/(01)50382903835367

Distribution

Distributed nationwide across the United States.

Related recalls

Same category