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Class 2 Device Recall Cardiac Cath Pack Kit |
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Date Initiated by Firm |
January 29, 2009 |
Date Posted |
January 29, 2010 |
Recall Status1 |
Terminated 3 on June 16, 2011 |
Recall Number |
Z-0745-2010 |
Recall Event ID |
51104 |
Product Classification |
Cardiovascular procedure kit - Product Code OEZ
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Product |
Custom Cardiac Cath Pack Kit, K09-08945, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Intended for fluid management convenience when catheterization is required. |
Code Information |
Lot number: F565427. |
Recalling Firm/ Manufacturer |
Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan UT 84095
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For Additional Information Contact |
801-253-1600
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Manufacturer Reason for Recall |
A manufacturing defect may prevent adequate sterilization of the entire device.
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FDA Determined Cause 2 |
Process control |
Action |
Applicable Merit sales representatives and distributors were notified by phone and letter beginning January 29, 2009 and instructed to immediately contact all affected consignees. Consignees were to immediately quarantine any remaining product and arrange for return to the firm.
For further information, contact Merit Medical Systems, Inc. at 1-800-356-3748 extensions 4929 or 4998. |
Quantity in Commerce |
20 units |
Distribution |
Worldwide Distribution -- United States ( PA and TX) and Japan. |
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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