![]() ![]() Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.ĥ10(K)s with Product Code = FPA and Original Applicant = BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 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. It can be found on at ġ A record in this database is created when a firm initiates a correction or removal action. FREE SHIPPING ON ORDERS 99+ WITHIN CANADA. B-D issued a press release on Febriuary 8, 2010. shop online for lowest prices on ADAPTER Q-SYTE VIAL ACCESS BX/25 in Canada. A response card was included to be returned whether or not product was on hand. BD Q-Syte Luer Access Split Septum combines the convenience of a Luer access with the benefits of a split septum design to provide closed access for I. Another letter was sent to all affected customers on notifying them of the extension of the recall to include Nexiva products. For information, call the company at 80, option 2, extension 2341. ![]() Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.Ĭonsignees were notified by B-D Urgent Medical Device Recall letter on and asked to return all unused affected lots. The benefits of this unique split septum design include reliable performance, high flow rates, and a visible fluid path. Product Code FPAīD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Systems Inc. The BD Q-Syte Luer Access Split Septum combines the convenience of a Luer access with the benefits of a split septum design to provide closed access for IV therapy. Class 1 Device Recall BD QSyte Vial Access Adapter, Luer access adapter
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