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U.S. Department of Health and Human Services

Class 2 Device Recall Pressure monitoring kit

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 Class 2 Device Recall Pressure monitoring kitsee related information
Date Initiated by FirmJuly 01, 2005
Date PostedSeptember 21, 2005
Recall Status1 Terminated 3 on August 09, 2011
Recall NumberZ-1563-05
Recall Event ID 32610
510(K)NumberK935782 
Product Classification System, Measurement, Blood-Pressure, Non-Invasive - Product Code DXN
ProductBD DTX Plus, Custom single-line pressure monitoting kit.
Code Information Part number 687196, Lot number 410174.
FEI Number 1710034
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 2		Other
ActionConsignees were notified by phone and fax on 07/01/2004.
Quantity in Commerce85 units
DistributionNationwide, including VA facilities in NY, SD, IL, OH and military facilities in GA, NC and Guam. Foreign distribution to Japan.
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 = DXN
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