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U.S. Department of Health and Human Services

Class 2 Device Recall StayFix

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  Class 2 Device Recall StayFix see related information
Date Initiated by Firm September 29, 2009
Date Posting Updated December 14, 2009
Recall Status1 Terminated 3 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/
Merit Medical Systems, Inc.
1600 Merit Pkwy
South Jordan UT 84095
For Additional Information Contact
Manufacturer Reason
for Recall
Potential sterility breach caused by excessive shipment damage.
FDA Determined
Cause 2
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.