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U.S. Department of Health and Human Services

Class 2 Device Recall Merit Custom Kits

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  Class 2 Device Recall Merit Custom Kits see related information
Date Initiated by Firm October 25, 2010
Date Posted December 08, 2010
Recall Status1 Terminated 3 on March 23, 2012
Recall Number Z-0558-2011
Recall Event ID 57176
510(K)Number K913682  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Custom Kit, Sterile EO, Rx Only, Catalog No. K09-10573, Manufactured by Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,
Code Information Lot No.: F745418, F761637, F765749, F770801, F771911, F781166, H101576, H117117, H139097
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan UT 84095
For Additional Information Contact Jackie Preece
801-208-3378
Manufacturer Reason
for Recall		 Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
FDA Determined
Cause 2		 Process control
Action Merit issued an Urgent Product Recall Notice letter dated October 25, 2010 to consignees. Copnsignees were instructed to quarantine the product immediately for return and to notify customers of recall activity and instruct them to return product.. All distributors and customers are to complete and return a Recall Notification Form. For further information about this recall, contact Merit at 800 356-3748.
Quantity in Commerce 265 units
Distribution Nationwide Distribution in the states of CA, IL, IN, and UT.
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 = DQO and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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