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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 February 15, 2007
Date Posted March 15, 2007
Recall Status1 Terminated 3 on November 09, 2011
Recall Number Z-0628-2007
Recall Event ID 37422
Product Classification Percutaneous catheter fixation device. - Product Code KMK
Product StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit Medical, Unomedical, Ltd., Great Britain.
Code Information Lot Numbers: 547745, 551172, 554699, 555705, 555706, 556394, 556395, 556396, 556876, 556877, 558988, 560767, 560768, 560781, 561127, 561144, 562749, 562750, 563256, 563257, 563387, 564684, 564685, 565284, 565285, 565353, 565955, 566684, 566905, 566906, 566907, 567383, 567513, 567728, 569474.
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc
1600 West Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
801-208-4284
Manufacturer Reason
for Recall		 Sterility of some units may be compromised due to damaged packaging.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on 02/23/2007. They were instructed to stop use of and return all affected product to Merit.
Quantity in Commerce 51,584 units
Distribution Worldwide, including USA, France, Germany, and United Kingdom.
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.
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