FDA Recall Terminated

BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536

Recall: Z-1710-2019 · Initiated March 1, 2019

Recall

Recall Number
Z-1710-2019
Event Number
82330
Firm
Becton Dickinson & Company
FEI Number
2243072
Product Code
FOZ
Status
Terminated
Root Cause
Release of Material/Component prior to receiving test results
Initiated
March 1, 2019
Terminated
May 21, 2020
Address
1 Becton Dr, Franklin Lakes, NJ, 07417-1815

Description

BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536

Reason

Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.

Action

BD MDS (Medication Delivery Solutions) contacted via email and provided a hard copy letter via FedEx on March 1, 2019. The tetter describes the problem , action to take: Immediately review your inventory for the specific Catalog and lot number listed above.Destroy all product subject to the recall following your institutions process for destruction. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. . Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement BD is requesting the distributor to identify their customers and either notify their customers regarding the recall or provide BD a customer list. BD will mail additional communications to the customers that are identified on the lists provided by the distributor. Questions: Customer/Technical Support 888-237-2762 OPT 3, OPT 2 Monday Friday between 8:00am and 5:00pm (EST

Distribution

US distribution to one distributor in VA.

Quantity

6,720 units