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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DQO
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