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U.S. Department of Health and Human Services

Class 1 Device Recall Catheter introducer

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 Class 1 Recall
Catheter introducer
see related information
Date Posted January 28, 2011
Recall Status1 Terminated on July 11, 2011
Recall Number Z-0941-2011
Recall Event ID 57540
Premarket Notification
510(K) Number
K082063 
Product Classification Introducer, Catheter - Product Code DYB
Product Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO, Merit Medical, South Jordan, Utah. Intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. Can also provide access to a native or synthetic graft used for hemodialysis.
Code Information Lot Number: H179575
Recalling Firm/
Manufacturer
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, Utah 84095
Manufacturer Reason
for Recall
Introducer tips may detach and embolize during use, or the tip material may elicit a thrombogenic response.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action Merit Medical Systems, Inc., issued an "Urgent Product Recall Notice" dated December 17, 2010, and contacted all customers (sales reps and authorized distributors) via email, phone and/or fax. The notice described the product, problem and action to be taken by the customers (Sales reps/Distributors). The customers were instructed to contact all their customers to identify, quarantine and return all unused inventory and extend the recall to any of their customers who may have received the affected products. The customers were instructed to complete and return the Manufacturer RECALL NOTIFICATION and Product Retrieval Form via fax to 1-801-208-3378 and send original to: the Manager, Customer Service, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, UT 84095-2416. Questions should be directed to the Senior Product Manager at 801-208-4344 or the Manager, Customer Service at 801-208-4365.
Quantity in Commerce 378 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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