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
|
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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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