The Recall Desk
HighFDA (Devices)·Z-0384-2019·Announced 2018-11-14

BD Nexiva IV Catheter Recall Due to Needle Shield Failure

Becton Dickinson is recalling 133,230 units of BD Nexiva Closed IV Catheter Systems because a needle shield defect may increase the risk of contaminated needlestick injuries.

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: The recall involves a medical device defect that increases the risk of contaminated needlestick injuries, which falls under the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Company is recalling 133,230 units of the BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (Catalog Number 383539). The recall affects Lot 8087800, identified by UDI (01)30382903835394. These devices are 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.

The recall is being issued because one lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism. This defect may lead to an increased risk of a contaminated needlestick injury. The BD Nexiva device is designed to protect clinicians from accidental needle stick injuries and minimize exposure to blood during the insertion process, but the safety mechanism in this lot may not function correctly.

The affected products were distributed worldwide, including nationwide in the United States 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 also distributed to Argentina, Australia, Belgium, Brazil, Canada, Colombia, Costa Rica, Mexico, and New Zealand. Healthcare facilities and distributors should check their inventory for this specific lot number and UDI and stop using the affected devices.

The recalled product

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 shield
Affected units
133,230

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 (2)

  • Lot 8087800
  • UDI (01)30382903835394

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically: