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U.S. Department of Health and Human Services

Class 2 Device Recall Performa Cardiac Multipack Catheter

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 Class 2 Device Recall Performa Cardiac Multipack Cathetersee related information
Date Initiated by FirmSeptember 13, 2013
Date PostedOctober 22, 2013
Recall Status1 Terminated 3 on January 03, 2014
Recall NumberZ-0045-2014
Recall Event ID 66400
510(K)NumberK943739 
Product Classification cardiac angiographic catheter - Product Code DQO
ProductMerit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
Code Information Part Number/Lot Number: 7560-43/I663860, 7560-43/I663861, 7560-G3/I664519 and 7560-G3/I666388. 
FEI Number 1721504
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan UT 84095
For Additional Information ContactCasey Hughes
801-316-4932
Manufacturer Reason
for Recall		4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.
FDA Determined
Cause 2		Process control
ActionConsignees were notified on 9/13/13 via Urgent Product Recall Notice, email, and product retrieval forms. Actions required of customers: 1. Please immediately determine if any of the devices are within your facility, quarantine them and discontinue use. 2. Ensure that all personnel to whom the devices were distributed are made aware of this field action. 3. Contact your Merit Sales Representative in order to arrange product return and replacement or credit. 4. If you have any questions concerning this communication, please don't hesitate to contact Guido Sandulli at 1-801-826-4046.
Quantity in Commerce200
DistributionUS Distribution including the states of CO, VA, and MS.
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 = DQO
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