| Class 3 Device Recall Custom Waste Management Kit | |
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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = DQO
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