| Class 2 Device Recall StayFix | |
Date Initiated by Firm | February 15, 2007 |
Date Posted | March 15, 2007 |
Recall Status1 |
Terminated 3 on November 09, 2011 |
Recall Number | Z-0627-2007 |
Recall Event ID |
37422 |
Product Classification |
Percutaneous catheter fixation device. - Product Code KMK
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Product | StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Merit Medical, Unomedical, Ltd., Great Britain. |
Code Information |
Lot numbers: 551268, 551537, 551615, 551616, 551702, 551703, 551704, 553104, 553360, 553361, 553362, 553363, 554362, 554367, 554368, 554483, 554497, 554504, 554505, 554506, 554723, 554764, 554765, 554766, 555638, 555639, 555655, 555656, 555657, 555658, 556406, 556407, 556408, 556409, 556410, 556411, 556842, 556843, 556844, 556845, 556846, 556847, 556871, 556872, 556873, 556874, 556875, 562518, 562748, 562874, 563254, 563255, 563388, 563389, 566538, 566899, 566900, 566901, 566902, 566903, 566904, 567248, 567515, 567596, 567599, 567600, 567601, 567767, 567835. |
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 | 195,001 units |
Distribution | Worldwide, including USA, France, Germany, and United Kingdom. |
Total Product Life Cycle | TPLC Device Report |
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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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