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U.S. Department of Health and Human Services

Class 1 Device Recall BD QSyte Extension Set, Luer access extension

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  Class 1 Device Recall BD QSyte Extension Set, Luer access extension see related information
Date Initiated by Firm October 19, 2009
Date Posted February 02, 2010
Recall Status1 Terminated 3 on October 19, 2010
Recall Number Z-0751-2010
Recall Event ID 53749
510(K)Number K013621  
Product Classification Intravascular administration set. - Product Code FPA
Product BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF 385101, Becton Dickinson Infusion Therapy Systems Inc.
Code Information Lot numbers: 8305510, 8331944.
Recalling Firm/
Becton Dickinson Medical Systems
9450 S State St
Sandy UT 84070-3213
For Additional Information Contact
Manufacturer Reason
for Recall
Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
FDA Determined
Cause 2
Process control
Action Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Quantity in Commerce 42,600 units
Distribution Nationwide distribution.
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 = BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.