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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiac Cath Pack

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  Class 2 Device Recall Cardiac Cath Pack see related information
Date Initiated by Firm January 29, 2009
Date Posted January 29, 2010
Recall Status1 Terminated 3 on June 16, 2011
Recall Number Z-0744-2010
Recall Event ID 51104
Product Classification Cardiovascular procedure kit - Product Code OEZ
Product University Health System Custom Cardiac Cath Pack, K09T-02178, Srterile EO, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095.

Intended for fluid management convenience when catheterization is required.
Code Information Lot numbers: V622183, V630959, V650165.
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan UT 84095
For Additional Information Contact
801-253-1600
Manufacturer Reason
for Recall		 A manufacturing defect may prevent adequate sterilization of the entire device.
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 368 units
Distribution Worldwide Distribution -- United States ( PA and TX) and Japan.
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.
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