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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 Catheter see related information
Date Initiated by Firm September 13, 2013
Date Posted October 22, 2013
Recall Status1 Terminated 3 on January 03, 2014
Recall Number Z-0045-2014
Recall Event ID 66400
510(K)Number K943739  
Product Classification cardiac angiographic catheter - Product Code DQO
Product Merit 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. 
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan UT 84095
For Additional Information Contact Casey 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
Action Consignees 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 Commerce 200
Distribution US Distribution including the states of CO, VA, and MS.
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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