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U.S. Department of Health and Human Services

Class 2 Device Recall CareFusion

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  Class 2 Device Recall CareFusion see related information
Date Initiated by Firm May 02, 2019
Create Date October 07, 2019
Recall Status1 Terminated 3 on November 30, 2021
Recall Number Z-0049-2020
Recall Event ID 82970
510(K)Number K083472  
Product Classification Set, administration, intravascular - Product Code FPA
Product CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy

Cat. No. MP1000-C
Code Information Lot Number: 18085990; Exp. Date: 15-Aug-2023 UDI: 10885403223228
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		 After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population.
FDA Determined
Cause 2		 Under Investigation by firm
Action BD MDS (Medication Delivery Solutions) initiated communication to US on May 2, 2019 via Fed'X. Letter states product defect, health risk and action to take:1. Immediately review for the specific Catalogue (Ref) and lot numbers . Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users of the product within your facility to ensure that 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 and process your product replacement. Regional Customer Quality 888-237-2762 OPT 3, OPT 2 Monday  Friday between the hours of 8:00am and 5:00pm (CST)
Quantity in Commerce 115,200
Distribution Nationwide Foreign: Canada
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 = FPA and Original Applicant = MEDEGEN INC.
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