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U.S. Department of Health and Human Services

Class 2 Device Recall Performa Cardiac Multipack

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  Class 2 Device Recall Performa Cardiac Multipack see related information
Date Initiated by Firm May 02, 2013
Date Posted May 25, 2013
Recall Status1 Terminated 3 on July 22, 2013
Recall Number Z-1408-2013
Recall Event ID 65150
510(K)Number K943739  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Merit Medical PerfOrma Anglographic Catheter 5F Multipack

Product Usage:
Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
Code Information Lot Numbers: 1662386, 1662390, 1662385, 1662387, 1662391 
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan UT 84095
For Additional Information Contact Casey Hughes
801-316-4932 Ext. 349
Manufacturer Reason
for Recall		 Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.
FDA Determined
Cause 2		 Process control
Action Merit sent an Urgent Product Recall Notice letter dated May 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to identify, quarantine, discontinue using products, and contact their sales representative to arrange product return and replacement or credit. For questions call 1-801-208-4468.
Quantity in Commerce 1,465
Distribution USA Nationwide Distribution.
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 = MALLINCKRODT MEDICAL
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