Class 2 Device Recall Pressure monitoring kit

• Date Initiated by Firm: July 01, 2005
• Date Posted: September 21, 2005
• Recall Status: Terminated on August 09, 2011
• Recall Number: Z-1557-05
• Recall Event ID: 32610
• 510(K)Number: K935782
• Product Classification: System, Measurement, Blood-Pressure, Non-Invasive - Product Code DXN
• Product: BD DTX Plus, 60'' complete single-line pressure monitoring kit.
• Code Information: Part Number 682000, Lot Numbers: 407104, 407387
• Recalling Firm/ Manufacturer: Becton Dickinson Medical Systems; 9450 S State St; Sandy UT 84070-3213
• For Additional Information Contact: 801-565-2772
• Manufacturer Reason for Recall: Actuating tab may detach from the stopcock body, allowing fluid leak.
• FDA Determined Cause: Other
• Action: Consignees were notified by phone and fax on 07/01/2004.
• Quantity in Commerce: 5470 units
• Distribution: Nationwide, including VA facilities in NY, SD, IL, OH and military facilities in GA, NC and Guam. Foreign distribution to Japan.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = DXN and Original Applicant = OHMEDA MEDICAL