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U.S. Department of Health and Human Services

Class 2 Device Recall BD Nexiva Closed IV Catheter System Dual Port

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  Class 2 Device Recall BD Nexiva Closed IV Catheter System Dual Port see related information
Date Initiated by Firm September 14, 2020
Create Date October 19, 2020
Recall Status1 Terminated 3 on September 27, 2021
Recall Number Z-0125-2021
Recall Event ID 86434
510(K)Number K183399  
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
Product BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN)
Catalog (Ref) No. 383538

BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
Code Information Lot Number: 9325212 UDI: 30382903835387
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		 Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens issued an "URGENT MEDICAL DEVICE RECALL" letter dated 9/14/20 to Distributors/Medical Facilities on 9/14/20 via FedX , email or faxed stating reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific Catalog (Ref) and Lot number listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users within or outside your facility network to which you may have further distributed the affected product to ensure they are also aware of this recall. 3. 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 per FDA requirements and subsequently process your product replacement. BD Customer/Technical Support, (844) 823-5433 Monday  Friday between 8:30am and 5:00pm (EST) in the United States. For customers outside the US, contact your local BD representative or distributor.
Quantity in Commerce 12,020 units
Distribution US: Nationwide Distribution: AK, AR, AZ, CA, IL, KS, MO, NY, OH, UT, VA; and International to: Canada and Mexico.
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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