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U.S. Department of Health and Human Services

Class 2 Device Recall Convenience Kit

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  Class 2 Device Recall Convenience Kit see related information
Date Initiated by Firm April 10, 2008
Date Posted September 19, 2008
Recall Status1 Terminated 3 on September 22, 2008
Recall Number Z-1808-2008
Recall Event ID 47881
Product Classification Kit, surgical instrument, disposable - Product Code KDD
Product Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products' intended uses.
Code Information Lot Number V477096
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
801-208-4795
Manufacturer Reason
for Recall		 Sterility Compromised - Component of convenience kit was recalled by its manufacturer for non-sterility.
FDA Determined
Cause 2		 Packaging
Action Site Visit - There is only one consignee that received product. That single consignee was visited by Merit sales rep on 04/14/2008 with instructions to discontinue use and quarantine any affected product. No Hemovac inventory and no affected kits remained in Merit's inventory at the time of notification from Zimmer. The consignee site representative verified that all 60 of the affected kits received by them had already been used.
Quantity in Commerce 30 kits
Distribution Class II Recall - Nationwide Distribution --- including state of NY.
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.
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