Class 2 Device Recall StayFix

• Date Initiated by Firm: September 29, 2009
• Date Posted: December 14, 2009
• Recall Status: Terminated on December 15, 2009
• Recall Number: Z-0521-2010
• Recall Event ID: 53557
• Product Classification: Catheter Fixation Device - Product Code KGZ
• Product: Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation Device for Percutaneous Catheters Used to secure catheters in place without the use of sutures, reducing the exposure of sharps and sharp-related accidents.
• Code Information: Lot #9H4824
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 Merit Pkwy; South Jordan UT 84095
• For Additional Information Contact: 801-253-1600
• Manufacturer Reason for Recall: Potential sterility breach caused by excessive shipment damage.
• FDA Determined Cause: Other
• Action: Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.
• Quantity in Commerce: 5 fixation devices
• Distribution: US (AL, LA, MO, KY, TN, GA). 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.