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.