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U.S. Department of Health and Human Services

Class 2 Device Recall BD Nexiva Closed IV Catheter System

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  Class 2 Device Recall BD Nexiva Closed IV Catheter System see related information
Date Initiated by Firm March 01, 2019
Create Date June 03, 2019
Recall Status1 Terminated 3 on May 21, 2020
Recall Number Z-1710-2019
Recall Event ID 82330
510(K)Number K161777  
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
Product BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system
Catalog Number: 383536
Code Information Lot Number: 8337721 Exp. 30-Nov-2021 UDI: 382903835362
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact SAME
201-847-6800
Manufacturer Reason
for Recall		 Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.
FDA Determined
Cause 2		 Release of Material/Component prior to receiving test results
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
Quantity in Commerce 6,720 units
Distribution US distribution to one distributor in VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FOZ and Original Applicant = Becton Dickinson Infusion Therapy Systems, Inc.
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