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Class 2 Device Recall Fluid Administration Set |
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Date Initiated by Firm |
April 08, 2008 |
Date Posted |
September 11, 2008 |
Recall Status1 |
Terminated 3 on April 06, 2009 |
Recall Number |
Z-1800-2008 |
Recall Event ID |
47880 |
510(K)Number |
K915678
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Product Classification |
Catheter, biliary, diagnostic - Product Code FPA
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Product |
Fluid Administration Set, Custom Kit, REF: K09-05336DP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline from a container to a patient's vascular system. |
Code Information |
Lot Number F605813 |
Recalling Firm/ Manufacturer |
Merit Medical Systems, Inc. 1600 Merit Pkwy South Jordan UT 84095-2416
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For Additional Information Contact |
801-208-4119
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Manufacturer Reason for Recall |
Convenience kits may contain non-filtered drip chambers.
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FDA Determined Cause 2 |
Mixed-up of materials/components |
Action |
An Urgent Product Recall Notice was issued on 04/08/2008 requiring that all affected product be returned to Merit. A response form was included with the notification letter. |
Quantity in Commerce |
99 kits |
Distribution |
Class II Recall - Nationwide Distribution --- including states of IL, SC, VA, 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 = FPA and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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