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FDA (Device enforcement)Recalled 2018-08-23closedclass ii

Becton Dickinson & Company: 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 (hereaft

Is my product affected?

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 shielding mechanism that is act

  • UPC 30382903835394

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson & Company is recalling one lot of BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN catheters (Catalog Number 383539, Lot 8087800) due to a failure in the needle tip shield/safety mechanism. This defect may increase the risk of contaminated needlestick injury. The affected lot consists of 133,230 units that were distributed nationwide across 17 U.S. states and to nine foreign countries including Canada, Australia, Mexico, and Brazil.

The recall affects healthcare facilities and providers who received this catheter lot in California, Colorado, Florida, Georgia, Illinois, Louisiana, Michigan, North Dakota, Nebraska, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Virginia, Washington, and West Virginia, as well as in Argentina, Australia, Belgium, Brazil, Canada, Colombia, Costa Rica, Mexico, and New Zealand. The source document does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick injury.

Details from the source

Reason for recall: One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick injury. Distribution: Worldwide Distribution -US Nationwide 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 distributed to the following foreign countries: Argentina, Australia, Belgium, Brazil, Canada, Colombia, Costa Rica, Mexico and New Zealand. Quantity: 133,230 units Lot/code info: Lot 8087800, UDI (01)30382903835394

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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