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U.S. Department of Health and Human Services

Class 2 Device Recall MAJESTIK

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 Class 2 Recall
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Date Posted December 14, 2009
Recall Status1 Terminated on December 15, 2009
Recall Number Z-0514-2010
Recall Event ID 53557
Product Classification Injector And Syringe, Angiographic - Product Code DXT
Product Merit Advance Angiographic Needle label reading in part: MAJESTIK SERIES ANGIOGRAPHIC NEEDLES 20 G CATALOG NUMBER AN20T52C for the introduction of vascular access devices.
Code Information Lot #F611693
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 25 angiographic needles
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.