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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 Recall
BD QSyte Extension Set, Luer access extension
see related information
Date Posted February 02, 2010
Recall Status1 Terminated on October 19, 2010
Recall Number Z-0752-2010
Recall Event ID 53749
Premarket Notification
510(K) Number
K013621 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102, Becton Dickinson Infusion Therapy Systems Inc.
Code Information Lot numbers: 8305511, 8308330, 8354561, 9012072
Recalling Firm/
Manufacturer
Becton Dickinson Medical Systems
9450 S State St
Sandy, Utah 84070-3213
Consumer Instructions No consumer action necessary
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
PRODUCTION CONTROLS: 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 144,900 units
Distribution Nationwide distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
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