| Class 1 Device Recall BD QSyte Extension Set, Luer access extension | |
Date Initiated by Firm | October 19, 2009 |
Date Posted | February 02, 2010 |
Recall Status1 |
Terminated 3 on October 19, 2010 |
Recall Number | Z-0752-2010 |
Recall Event ID |
53749 |
510(K)Number | K013621 |
Product Classification |
Intravascular administration set. - Product Code FPA
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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 UT 84070-3213
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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 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = FPA
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