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U.S. Department of Health and Human Services

Class 2 Device Recall Prelude Short Sheath Introducer

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  Class 2 Device Recall Prelude Short Sheath Introducer see related information
Date Initiated by Firm September 29, 2009
Date Posted December 14, 2009
Recall Status1 Terminated 3 on December 15, 2009
Recall Number Z-0518-2010
Recall Event ID 53557
510(K)Number K082063  
Product Classification Short Sheath Introducer - Product Code DYB
Product Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER 21G 6F-SMT 4 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries.
Code Information Lot #: F732268S1
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 Merit Pkwy
South Jordan UT 84095
For Additional Information Contact
801-253-1600
Manufacturer Reason
for Recall		 Potential sterility breach caused by excessive shipment damage.
FDA Determined
Cause 2		 Other
Action Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.
Quantity in Commerce 1 Short Sheath
Distribution US (AL, LA, MO, KY, TN, GA). No military, government or foreign 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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