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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 Recall
Prelude Short Sheath Introducer
see related information
Date Posted December 14, 2009
Recall Status1 Terminated on December 15, 2009
Recall Number Z-0517-2010
Recall Event ID 53557
Premarket Notification
510(K) Number
Product Classification Introducer, Catheter - 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 #: F696474
Recalling Firm/
Merit Medical Systems, Inc.
1600 Merit Pkwy
South Jordan, Utah 84095
Manufacturer Reason
for Recall
Potential sterility breach caused by excessive shipment damage.
FDA Determined
Cause 2
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 4 Sheaths
Distribution US (AL, LA, MO, KY, TN, GA). No military, government or foreign 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.