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U.S. Department of Health and Human Services

Class 1 Device Recall 7F Prelude Short Sheath Introducer

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  Class 1 Device Recall 7F Prelude Short Sheath Introducer see related information
Date Initiated by Firm February 16, 2017
Date Posted March 24, 2017
Recall Status1 Terminated 3 on August 08, 2017
Recall Number Z-1497-2017
Recall Event ID 76596
510(K)Number K082063  
Product Classification Introducer, catheter - Product Code DYB
Product 7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT.

Produc Usage:
The Merit Prelude¿ Short Sheath Introducer is 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. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.
Code Information Lot Numbers: H1041469, H1041473, H1036880, H1041464.
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact Cory Marsh
801-253-1600
Manufacturer Reason
for Recall		 Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude¿ Short Sheath Introducers because the sheath marker tips may detach during use.
FDA Determined
Cause 2		 Process control
Action Consignees notified on 2/16/17 to immediately stop using or distributing the affected lots and return them to Merit. For any questions, please contact your Merit Sales Representative or Merit Customer Service at 801.208.4381.
Quantity in Commerce 1,265 total
Distribution Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
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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