Becton Dickinson Infusion Therapy Systems Inc. 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 catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon" catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, dual port adapter, Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

There is a breach in the product packaging that renders the product non-sterile.

Recommended Action

Per FDA guidance

On September 30, 2021, the firm sent out a customer notification letter "Urgent Medical Device Recall" to their customers via Fed-Ex with the instruction due to the packaging breach, identified during the in house internal leak testing. This breach in the product packaging rendered the enclosed IV catheters non-sterile. Holes have been detected on the bottom tray of device unit packages. The notification stated to destroy the devices which are present in customers/distributors inventory. The recalling firm notified in a customer notification letter to fill and send the customer response form with customer's details and acknowledgement of destruction of the device list , lot number and quantities for the replacement. The contact information will be provided for the customers to call : 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 The customer response form to be returned via: E-Mail BDRC17@bd.com, Fax No. is 312-949-0375.