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U.S. Department of Health and Human Services

Class 2 Device Recall Vessel Sizing Angiographic Catheter

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 Class 2 Recall
Vessel Sizing Angiographic Catheter
see related information
Date Posted May 28, 2010
Recall Status1 Terminated on June 01, 2010
Recall Number Z-1731-2010
Recall Event ID 55661
Premarket Notification
510(K) Number
K000659 
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
Product Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
Code Information Lot Number: G775032
Recalling Firm/
Manufacturer
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, Utah 84095
Manufacturer Reason
for Recall
Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Merit Medical Systems, Inc. began notifying sales representatives beginning May 5, 2010 via phone and instructed to contact all of their affected accounts. All affected product was to be returned to the firm. For further information, contact Merit Medical at 1-713-757-5067 or 1-801-208-4468.
Quantity in Commerce 96 units
Distribution Nationwide Distribution -- GA, IL, MO, NY, PA and WI.
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 = DQO and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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