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Class 2 Device Recall Large Bore Male Luer for use in Fluid Administration Sets. |
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Date Initiated by Firm |
April 17, 2007 |
Date Posted |
May 31, 2007 |
Recall Status1 |
Terminated 3 on May 05, 2008 |
Recall Number |
Z-0844-2007 |
Recall Event ID |
37902 |
510(K)Number |
K915678
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Product Classification |
IV set - Product Code FMG
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Product |
Luer Male Large Bore, REF/CAT No.: 102100001, for use in fluid administration sets, 40000. |
Code Information |
Lot Number F28005. |
Recalling Firm/ Manufacturer |
Merit Medical Systems, Inc. 1600 Merit Pkwy South Jordan UT 84095-2416
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For Additional Information Contact |
801-208-4405
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Manufacturer Reason for Recall |
Male luer in fluid administration sets may crack due to inadequate molding process
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letter on 04/17/2007 and instructed to quarantine and return any unused product. |
Quantity in Commerce |
40,000 units |
Distribution |
CA, IL, NJ, NY. No military, government or foreign distribution. |
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 = FMG and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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