Date Initiated by Firm |
September 23, 2016 |
Date Posted |
November 19, 2016 |
Recall Status1 |
Terminated 3 on March 27, 2017 |
Recall Number |
Z-0633-2017 |
Recall Event ID |
75367 |
Product Classification |
Single use instrument tray - Product Code OJV
|
Product |
Waste Management Kit. Catalog Number K10-04381AP |
Code Information |
Lot Number: H996569 |
Recalling Firm/ Manufacturer |
Merit Medical Systems, Inc. 1600 W Merit Pkwy South Jordan UT 84095-2416
|
For Additional Information Contact |
Ileana Davis 801-253-1600
|
Manufacturer Reason for Recall |
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
|
FDA Determined Cause 2 |
Process control |
Action |
Consignees notified via letter on 09/23/16 to quarantine any devices and discontinue use, ensure all personnel to whom the devices were distributed are made aware of the field action, and return affected devices to Merit Medical. |
Quantity in Commerce |
30 units |
Distribution |
Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees. |
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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