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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 Kitssee related information
Date Initiated by FirmOctober 25, 2010
Date PostedDecember 08, 2010
Recall Status1 Terminated 3 on March 23, 2012
Recall NumberZ-0559-2011
Recall Event ID 57176
510(K)NumberK913682 
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
ProductCustom Kit, Sterile EO, Rx Only, Catalog No. K09-10573, Revision A, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,
Code Information Lot No.: H158143
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan UT 84095
For Additional Information ContactJackie 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
ActionMerit 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 Commerce57 units
DistributionNationwide Distribution in the states of CA, IL, IN, and UT.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQO
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