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U.S. Department of Health and Human Services

Class 2 Device Recall Large Bore Male Luer for use in Fluid Administration Sets.

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  Class 2 Device Recall Large Bore Male Luer for use in Fluid Administration Sets. see related information
Date Initiated by Firm April 17, 2007
Date Posted May 31, 2007
Recall Status1 Terminated 3 on May 05, 2008
Recall Number Z-0845-2007
Recall Event ID 37902
510(K)Number K915678  
Product Classification IV set - Product Code FMG
Product Custom 72inch Spike LG Bore Sub, REF/CAT 520016, for use with fluid administration sets, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Code Information Lot Number F534043.
Recalling Firm/
Merit Medical Systems, Inc.
1600 Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
Manufacturer Reason
for Recall
Male luer in fluid administration sets may crack due to inadequate molding process
FDA Determined
Cause 2
Action Consignees were notified by letter on 04/17/2007 and instructed to quarantine and return any unused product.
Quantity in Commerce 400 units
Distribution CA, IL, NJ, NY. No military, government or foreign distribution.
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 = FMG and Original Applicant = MERIT MEDICAL SYSTEMS, INC.