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U.S. Department of Health and Human Services

Class 1 Device Recall BD QSyte, Luer Access connector

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 Class 1 Device Recall BD QSyte, Luer Access connectorsee related information
Date Initiated by FirmOctober 19, 2009
Date PostedFebruary 02, 2010
Recall Status1 Terminated 3 on October 19, 2010
Recall NumberZ-0750-2010
Recall Event ID 53749
510(K)NumberK013621 
Product Classification Intravascular administration set. - Product Code FPA
ProductBD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc.
Code Information Lot Numbers 8268863, 8269020, 8275798, 8308321, 8308323, 8309553, 8331937, 8331940, 8354558, 9007921, 9009643, 9009646, 9028838, 9035029, 99035032.
FEI Number 1710034
Recalling Firm/
Manufacturer		 Becton Dickinson Medical Systems
9450 S State St
Sandy UT 84070-3213
For Additional Information Contact
801-565-2341
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
ActionConsignees 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 Commerce950,000 units
DistributionNationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FPA
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