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U.S. Department of Health and Human Services

Class 2 Device Recall PreludeEASE

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  Class 2 Device Recall PreludeEASE see related information
Date Initiated by Firm December 01, 2016
Date Posted January 05, 2017
Recall Status1 Terminated 3 on April 18, 2017
Recall Number Z-0949-2017
Recall Event ID 75999
510(K)Number K140543  
Product Classification Introducer, catheter - Product Code DYB
Product PreludeEASE Hydrophilic Sheath Introducer Dilator
The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires
Code Information Lots: H1014678, H1039272, H1029150, H1039269, H1029151
Recalling Firm/
Manufacturer
Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact Luke Meidell
801-208-4623
Manufacturer Reason
for Recall
Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire.
FDA Determined
Cause 2
Process change control
Action Merit Medical sent an Urgent Product Recall Notice dated December 1, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to identify any affected devices within their facility, quarantine them, and discontinue use. Ensure that all personnel to whom the devices were distributed are made aware of this field action. Consignees were asked to work with their Merit Sales Representative to arrange product return. Consignees with questions were instructed to contact their Merit Sales Representative or Merit Customer Service at response@merit.com or at 801-208-4381. For questions regarding this recall call 801-208-4623.
Quantity in Commerce 335
Distribution Nationwide Distribution
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 = DYB and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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