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U.S. Department of Health and Human Services

Class 2 Device Recall StayFix

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 Class 2 Recall
StayFix
see related information
Date Posted December 14, 2009
Recall Status1 Terminated on December 15, 2009
Recall Number Z-0521-2010
Recall Event ID 53557
Product Classification Accessories, Catheter - 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, Utah 84095
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
Potential sterility breach caused by excessive shipment damage.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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