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U.S. Department of Health and Human Services

Class 2 Device Recall Fluid Administration Set

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  Class 2 Device Recall Fluid Administration Set see related information
Date Initiated by Firm April 08, 2008
Date Posting Updated September 11, 2008
Recall Status1 Terminated 3 on April 06, 2009
Recall Number Z-1800-2008
Recall Event ID 47880
510(K)Number K915678  
Product Classification Catheter, biliary, diagnostic - Product Code FPA
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/
Merit Medical Systems, Inc.
1600 Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
Manufacturer Reason
for Recall
Convenience kits may contain non-filtered drip chambers.
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

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.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = MERIT MEDICAL SYSTEMS, INC.