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U.S. Department of Health and Human Services

Class 2 Device Recall Mistique Infusion Catheter

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  Class 2 Device Recall Mistique Infusion Catheter see related information
Date Initiated by Firm January 06, 2010
Date Posted March 02, 2010
Recall Status1 Terminated 3 on September 13, 2010
Recall Number Z-0874-2010
Recall Event ID 54228
510(K)Number K974067  
Product Classification Continuous Flush Catheter - Product Code KRA
Product Mistique Infusion Catheter, MIC5-90-20-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095

Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
Code Information Lot Number: F523170.
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan UT 84095
For Additional Information Contact
801-253-1600
Manufacturer Reason
for Recall		 Infusion catheters may become brittle and break during use.
FDA Determined
Cause 2		 Storage
Action All affected sales reps were notified by phone and a Mistique Infusion Catheter - Product Recall letter on 01/06/2010 and instructed to contact their accounts, inform them of the recall situation, and complete the Recall Notification form with a site representative. Accounts were to immediately cease use of any affected units and to arrange for return to Merit. Recall actions are to be completed by Jan 22, 2010. Questions should be directed to Greg Turner at 801-316-4998 or Liz Pratt at 801-208-4828.
Quantity in Commerce 4 units
Distribution Worldwide Distribution -- USA, including states of AL, CA, IN, LA, MO, MS, NC, NY, OH, PA, SC, UT, and VA and countries of India, Japan, Poland, San Marino, and UK.
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 = KRA and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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