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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
K082063 
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/
Manufacturer
Merit Medical Systems, Inc.
1600 Merit Pkwy
South Jordan, Utah 84095
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
Potential sterility breach caused by excessive shipment damage.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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.
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