Class 2 Device Recall Convenience Kit

• Date Initiated by Firm: March 14, 2008
• Date Posted: September 11, 2008
• Recall Status: Terminated on September 09, 2008
• Recall Number: Z-2197-2008
• Recall Event ID: 48658
• Product Classification: Kit - Product Code KDD
• Product: CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, 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 V583783
• FEI Number: 1721504
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: 801-208-4349
• Manufacturer Reason for Recall: Component of convenience kit may not be sterile.
• FDA Determined Cause: Packaging
• Action: The sole direct account (distributor) and the sole end-user were notified by letter on 03/13-14/2008. Direct account was instructed to return any affected product still in inventory. End user was advised to discard the blades or re-sterilize them according to blade manufacturer's instructions, which were included. For assistance, contact Merit Medical at 1-801-208-4349.
• Quantity in Commerce: 36 kits
• Distribution: PA. No military, government, or foreign distribution.
• 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.