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U.S. Department of Health and Human Services

Class 3 Device Recall Custom Waste Management Kit

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  Class 3 Device Recall Custom Waste Management Kit see related information
Date Initiated by Firm September 12, 2008
Date Posted January 13, 2009
Recall Status1 Terminated 3 on January 13, 2009
Recall Number Z-0578-2009
Recall Event ID 49526
510(K)Number K913682  
Product Classification Diagnostic Intravascular Catheter - Product Code DQO
Product Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095
Code Information Lot number F622787
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 Merit Pkwy
South Jordan UT 84095
For Additional Information Contact
801-208-4748
Manufacturer Reason
for Recall		 Leak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak. For further information, please contact Merit Medical Systems, Inc. by telephone at 801-208-4748.
FDA Determined
Cause 2		 Process control
Action All consignees were notified by sales reps via phone, fax or visit between 09/15/2008 and 10/09/2008. Sales reps were to instruct them to immediately discontinue use and quarantine all affected products. A Product Retrieval Form was to be completed and signed by the customer's site representative. More information available at 801-316-4998.
Quantity in Commerce 399 kits
Distribution United States including the states of AR, AZ, CA, CO, FL, KY, IL, IN, MA, MI, MN, MO, NJ, NY, PA, SC, TX, UT, VA, WI, and WV. No military or foreign distribution. VA facilities in CA and FL.
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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