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Class 2 Device Recall Vessel Sizing Angiographic Catheter |
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Date Initiated by Firm |
May 05, 2010 |
Date Posted |
May 28, 2010 |
Recall Status1 |
Terminated 3 on June 01, 2010 |
Recall Number |
Z-1731-2010 |
Recall Event ID |
55661 |
510(K)Number |
K000659
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Product Classification |
Catheter, intravascular, diagnostic - Product Code DQO
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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 UT 84095
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For Additional Information Contact |
801-316-4932
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Manufacturer Reason for Recall |
Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = DQO and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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