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Class 1 Device Recall MPS Acacia TriExtension Set, Luer access extension |
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Date Initiated by Firm |
October 19, 2009 |
Date Posted |
February 02, 2010 |
Recall Status1 |
Terminated 3 on October 19, 2010 |
Recall Number |
Z-0756-2010 |
Recall Event ID |
53749 |
510(K)Number |
K013621
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Product Classification |
Intravascular administration set. - Product Code FPA
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Product |
MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164 |
Code Information |
Lot number: A1951 |
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
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Manufacturer Reason for Recall |
Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
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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 |
2,300 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 and Original Applicant = BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
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