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U.S. Department of Health and Human Services

Class 2 Device Recall Procedure Kit

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  Class 2 Device Recall Procedure Kit see related information
Date Initiated by Firm September 02, 2005
Date Posted October 21, 2005
Recall Status1 Terminated 3 on October 28, 2005
Recall Number Z-0077-06
Recall Event ID 33364
510(K)Number K913682  
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
Product Merit Custom Procedure Kit
Code Information Part Number: K08-01894, Lot Number A306856
Recalling Firm/
Merit Medical Systems, Inc
1600 West Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
Manufacturer Reason
for Recall
Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
FDA Determined
Cause 2
Action Consignees were notified by letter on 9/2/2005.
Quantity in Commerce 99 units
Distribution DC, MD, VA. Foreign distributiion to Netherlands and Switzerland. No government or military accounts.
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 = DQO and Original Applicant = MERIT MEDICAL SYSTEMS, INC.